Patient Safety Program Research Articles

A complex endeavour: an ethnographic study of the implementation of the Sepsis Six clinical care bundle.

BackgroundImplementation of the ‘Sepsis Six’ clinical care bundle within an hour of recognition of sepsis is recommended as an approach to reduce mortality in patients with sepsis, but achieving reliable delivery of the bundle has proved challenging. There remains little understanding of the barriers to reliable implementation of bundle components. We examined frontline clinical practice in implementing the Sepsis Six.MethodsWe conducted an ethnographic study in six hospitals participating in the Scottish Patient Safety Programme Sepsis collaborative. We conducted around 300 h of non-participant observation in emergency departments, acute medical receiving units and medical and surgical wards. We interviewed a purposive sample of 43 members of hospital staff. Data were analysed using a constant comparative approach.ResultsImplementation strategies to promote reliable use of the Sepsis Six primarily focused on education, engaging and motivating staff, and providing prompts for behaviour, along with efforts to ensure that equipment required was readily available. Although these strategies were successful in raising staff awareness of sepsis and engagement with implementation, our study identified that completing the bundle within an hour was not straightforward. Our emergent theory suggested that rather than being an apparently simple sequence of six steps, the Sepsis Six actually involved a complex trajectory comprising multiple interdependent tasks that required prioritisation and scheduling, and which was prone to problems of coordination and operational failures. Interventions that involved allocating specific roles and responsibilities for completing the Sepsis Six in ways that reduced the need for coordination and task switching, and the use of process mapping to identify system failures along the trajectory, could help mitigate against some of these problems.ConclusionsImplementation efforts that focus on individual behaviour change to improve uptake of the Sepsis Six should be supplemented by an understanding of the bundle as a complex trajectory of work in which improving reliability requires attention to coordination of workflow, as well as addressing the mundane problems of interruptions and operational failures that obstruct task completion.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-016-0518-z) contains supplementary material, which is available to authorized users.

Temporal Patterns of In-Hospital Falls of Elderly Patients.

A potentially important factor yet to receive adequate study is the time when hospital falls occur. A prior study conducted before the system-wide introduction of preventive measures revealed a biphasic 24-hour pattern of hospital falls with major peak in the morning. The purpose was to identify the temporal patterning of falls among elderly patients in hospitals with comprehensive fall prevention programs in place. A 4-year observational study was conducted by the local health authority in the five nonteaching public hospitals located in the province of Ferrara, Italy. Fall records involving patients of ages ≥65 years hospitalized in the general medical departments were used. Single- and multiple-component cosinor (time series) analyses were used to explore 24-hour, weekly, and annual patterns of falls. A total of 763 falls were experienced by 709 different elderly hospitalized patients. Falls typically took place in the patient's hospital room (72%) and bathroom (23%). Major causes were patient instability (32%) and accident (13%), and most occurred when not wearing footwear (45%) or wearing inappropriate sling-back open-toe shoes (39%). Falls happened while standing (39%), while seated (21%), and while getting into, out of, or laying in bed (32%)-either with the bed rails raised or lowered. Fall outcome usually involved no injury (58%) or slight injury (35%), but some (7%) were disabling. Fall occurrence was higher during the night (46%) compared to either the morning (30%) or afternoon (24%) shift. Patterns across 24 hours were characterized by a single major and one or more minor peaks that seemed to be associated with a variety of scheduled patient, hospital, and nursing activities. Multiple-component cosinor analysis identified significant (p < .05) prominent day-night patterns according to fall location, patient position, cause, injury severity, and type of footwear. Falls were more frequent, but not significantly so, on Fridays, Sundays, and Mondays compared with Tuesdays, and were more frequent in winter and spring (p = .003). Documentation by cause and circumstance of these moderate- to high-amplitude temporal patterns in hospital falls of elderly patients advances the knowledge of fall epidemiology by identifying the times of day, week, and year and nursing shifts of elevated risk that is of critical importance to improving hospital patient safety programs.

Patient safety and nursing implication: Survey in Catalan hospitals

ObjectiveThis study aims to describe the implementation of the patient safety (PS) programmes in Catalan hospitals and to analyse the level of nursing involvement. MethodMulticenter cross-sectional study. To obtain the data two questionnaires were developed; one addressed to the hospital direction and another to the nurse executive in PS. The survey was distributed during 2013 to the 65 acute care hospitals in Catalonia. ResultsThe questionnaire was answered by 43 nursing directors and 40 nurse executive in PS. 93% of the hospitals responded that they had a PS Programme and 81.4% used a specific scoreboard with PS indicators. The referent of the hospital in PS was a nurse in 55.8% of the centres. 92.5% had a system of notification of adverse effects with an annual average of 190.3 notifications. In 86% of the centres had a nurse involved in the PS programme but only in the 16% of the centres the nurse dedication was at full-time.The nurse respondents evaluate the degree of implementation of the PBS programme with a note of approved and they propound as improvement increase the staff dedicated to the PS and specific academic training in PS. ConclusionsThe degree of implementation of programmes for patient safety is high in Catalan acute hospitals, while the organisational structure is highly diverse. In more than half of the hospitals the PS referent was a nurse, confirming the nurse involvement in the PS programmes.

Engaging Learners Through Modules in Quality Improvement and Patient Safety.

Residents are on the front lines of medical care in academic institutions. Their daily interactions are crucial to the quality of care received by patients in these settings, and thus, knowledge of patient safety and quality improvement is essential. The Accreditation Council for Graduate Medical Education requires all residents to participate in quality improvement and patient safety programs as part of their residency training. To meet this need, we developed a curriculum in patient safety and quality improvement for pediatric residents. This curriculum describes four short modules focused on quality improvement, patient safety, evidence-based practice, and other quality improvement-related topics. These modules can be given during one rotation, throughout residency, or partnered with a practical application, such as a project. A 17-question quality improvement and patient safety knowledge test was developed after an extensive literature review to reflect module goals and objectives. A validated, 12-question attitudes survey was administered before and after the modules. Of the 57 eligible residents, 42 completed the knowledge pretest, and 20 completed the posttest. Mean posttest results (M = 91.00 [± 9.12]) were considerably higher than mean pretest scores (M = 75.24 [± 11.74]) when utilizing the independent t test (p &lt; .001). Of the 57 eligible residents, 11 completed the attitude presurvey, and 13 completed the attitude postsurvey. Median responses from the survey mostly fell within the 2-3 range of slightly to moderately comfortable. Significant differences showing improvement between presurvey and postsurvey time frames were found in identifying and comparing best practices (p = .02), using the PDSA model (p = .002), and identifying how data are linked (p = .001). Knowledge and perception surveys suggest that resident knowledge and attitudes statistically improved, and faculty and residents participated in even more quality improvement initiatives after completing the curriculum.

ISQUA16-2853ANALYSIS OF PATIENT SAFETY INCIDENTS IN BRAZILIAN ACCREDITED HOSPITALS - THE SAFETY SENTINEL PROJECT:

The objective of this study was to identify critical points concerning patient safety through the analysis of a database with compiled incident notifications from 107 health organizations in Brazil. Since 2002 IQG - Health Services Accreditation (IQG) follows the voluntary reporting of patient safety incidents, carried out by Brazilian accredited institutions. In 2014 the Brazilian Patient Safety Program (PBSP) team began to conduct this process, improving the communication channels, aiming to strengthen the safety and learning net, prioritize critical points concerning patient safety, identify intervention strategies, and promote best practices in incident analysis. Healthcare …

ISQUA16-2875THE BRAZILIAN PATIENT SAFETY PROGRAM - BUILDING A NETWORK TO HELP BRAZILIAN HOSPITALS TO IMPROVE QUALITY OF CARE OFFERED TO THE POPULATION

To create a network of collaboration and communication between Brazilian hospitals, who join voluntarily, generating a fundamental change in the culture of the hospitals, to exchange experiences, dissemination of best care practices, structuring clinical protocols related to the quality and safety of patient and promotion of training of multidisciplinary teams in order to continuously improve the quality of care in Brazil and the spread of a concept of intolerance to avoidable harm. In 2008, the IQG – Health Services Accreditation (IQG) developed the Brazilian Patient Safety Program (PBSP). Through the voluntary participation of Brazilian hospitals, the Program promotes the dissemination of safety practices and the exchange of experiences among …

Stop the Blame Game: Restructuring Morbidity and Mortality Conferences to Teach Patient Safety and Quality Improvement to Residents.

Adverse events leading to patient harm are rarely the result of an individual error but are instead due to a series of errors resulting from system breakdowns. Thus, the Accreditation Council for Graduate Medical Education requires all residents to participate in quality improvement and patient safety programs. However, a major reported obstacle to sustainable quality improvement and patient safety curricula, as well as meaningful practice improvement, is the small number of faculty with expertise or training in these topics. This workshop provides a simple framework for redesigning traditional morbidity and mortality conferences for faculty who have minimal quality improvement training. The materials associated with this publication include a standardized presentation template, sample teaching points, and a faculty facilitator's guide. Between August 2014 and February 2015, 135 trainees from one of our tertiary training sites attended seven of these redesigned conferences. The largest gains were made in teaching residents how to use a systems-based approach to analyze medical error and how to identify corresponding error-reduction strategies. Residents also perceived themselves as more likely to put their knowledge into action through filing an incident report after attending the conference. The one item that did not change was the residents' perception of safety culture at their institution, suggesting that attendance at a monthly conference is not sufficient to change culture. Similarly formatted M&Mconferences may help institutions address several aspectof the ACGME CLER program that provides programswith periodic feedback regarding trainee education onpatient safety and quality improvement as well.

The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study.

BackgroundResearch on patient safety has focused largely on secondary care settings, and there is a dearth of knowledge relating to safety culture or climate, and safety climate improvement strategies, in the context of primary care. This is problematic given the high rates of usage of primary care services and the myriad of opportunities for clinical errors daily. The current research programme aimed to assess the effectiveness of an intervention derived from the Scottish Patient Safety Programme in Primary Care. The intervention consists of safety climate measurement and feedback and patient chart audit using the trigger review method. The purpose of this paper is to describe the background to this research and to present the methodology of this feasibility study in preparation for a future definitive RCT.MethodsThe SAP-C study is a feasibility study employing a randomised controlled pretest-posttest design that will be conducted in 10 general practices in the Republic of Ireland and Northern Ireland. Five practices will receive the safety climate intervention over a 9-month period. The five practices in the control group will continue care as usual but will complete the GP-SafeQuest safety climate questionnaire at baseline (month 1) and at the terminus of the intervention (month 9). The outcomes of the study include process evaluation metrics (i.e. rates of participant recruitment and retention, rates of completion of safety climate measures, qualitative data regarding participants’ perceptions of the intervention’s potential efficacy, acceptability, and sustainability), patient safety culture in intervention and control group practices at posttest, and instances of undetected patient harm identified through patient chart audit using the trigger review method.DiscussionThe planned study investigates an intervention to improve safety climate in Irish primary care settings. The resulting data may inform our knowledge of the frequency of undetected patient safety incidents in primary care, may contribute to improved patient safety practices in primary care settings, and may inform future research on patient safety improvement initiatives.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-016-0096-5) contains supplementary material, which is available to authorized users.

Postoperative pain assessment in hospitalised patients: National survey and secondary data analysis

BackgroundMeasuring pain is important for the adequate pain management of postoperative patients. The actual compliance with pain assessment in postoperative patients after implementation of a national safety program is unknown. ObjectivesThe aim of this study is to examine the compliance with pain assessment in postoperative patients after implementation of a national safety program, according to the national quality indicators for pain assessment in postoperative patients. Furthermore, organisational factors associated with this compliance were determined. Study designIn this study, two data sources were used: 1) data from an evaluation study of the Dutch Hospital Patient Safety Program; and 2) data from a questionnaire survey. MethodsThe compliance with two different pain process indicators was determined: 1) 3 pain measurements a day, all three full days after surgery; and 2) ≥1 pain measurement a day, all three full days after surgery. Multilevel logistic regression analysis was used to investigate the association between organisational factors in hospitals and compliance with pain process indicators. ResultsData of 3895 patient records from 16 hospitals was included in this study. In 12% of the postoperative patients, pain was measured 3 times a day, all three full days after surgery. In 53% of the postoperative patients, pain was measured ≥1 time a day, all three full days after surgery. Compliance was highest in general hospitals compared to tertiary teaching and academic hospitals, and was statistically significantly higher at the surgery and surgical oncology department compared to the other departments. ConclusionsLow compliance was shown with pain assessment in postoperative patients, according to the process indicator pain after surgery in Dutch hospitals. This suggests that the implementation of measuring pain in hospitals is still insufficient.

Prediction of clinical risks by analysis of preclinical and clinical adverse events

Display Omitted The predictive value of animal safety studies for humans is studied.The statistical impact of specific adverse events for drug withdrawal is studied.Specific animal adverse events which impact human safety are identified.A model for predicting risk of withdrawal or drug failure due to safety is reported. This study examines the ability of nonclinical adverse event observations to predict human clinical adverse events observed in drug development programs. In addition it examines the relationship between nonclinical and clinical adverse event observations to drug withdrawal and proposes a model to predict drug withdrawal based on these observations. These analyses provide risk assessments useful for both planning patient safety programs, as well as a statistical framework for assessing the future success of drug programs based on nonclinical and clinical observations.Bayesian analyses were undertaken to investigate the connection between nonclinical adverse event observations and observations of that same event in clinical trial for a large set of approved drugs. We employed the same statistical methods used to evaluate the efficacy of diagnostic tests to evaluate the ability of nonclinical studies to predict adverse events in clinical studies, and adverse events in both to predict drug withdrawal. We find that some nonclinical observations suggest higher risk for observing the same adverse event in clinical studies, particularly arrhythmias, QT prolongation, and abnormal hepatic function. However the lack of these events in nonclinical studies is found to not be a good predictor of safety in humans. Some nonclinical and clinical observations appear to be associated with high risk of drug withdrawal from market, especially arrhythmia and hepatic necrosis. We use the method to estimate the overall risk of drug withdrawal from market using the product of the risks from each nonclinical and clinical observation to create a risk profile.

SEGURANÇA DO PACIENTE EM HOSPITAIS DE GRANDE PORTE: PANORAMA E DESAFIOS

O presente estudo tem por objetivo explorar a situação de segurança do paciente em quatro hospitais de grande porte de Santa Catarina. A amostra foi constituída pelos coordenadores de segurança do paciente e por profissionais da equipe multidisciplinar. Utilizou-se como instrumento de coleta de dados um questionário elaborado a partir de formulário proposto pela Organização Mundial de Saúde para avaliação da situação de segurança do paciente. Os principais resultados apontam para a necessidade de promover a cultura de segurança nas instituições de saúde, englobando: questões estruturais; de comunicação e educação permanente; melhorias nos processos de trabalho com ênfase em elaboração de protocolos e outros instrumentos de gestão; notificação e investigação de eventos adversos; avaliação de indicadores; fortalecimento de parcerias e pesquisas na área. Conclui-se que existem ações de segurança em desenvolvimento e um movimento para a implantação do Programa Nacional de Segurança do Paciente no Estado de Santa Catarina.

Alternatives to Indwelling Catheters Cause Unintended Complications

To reduce the risk of catheter-associated urinary tract infection (CAUTI), limiting use of indwelling catheters is encouraged with alternative collection methods and early removal. Adverse effects associated with such practices have not been described. We also determined if CAUTI preventative measures increase the risk of catheter-related complications. We hypothesized that there are complications associated with early removal of indwelling catheters. We described complications associated with indwelling catheterization and intermittent catheterization, and compared complication rates before and after policy updates changed catheterization practices. We performed retrospective cohort analysis of trauma patients admitted between August 1, 2009, and December 31, 2013 who required indwelling catheter. Associations between catheter days and adverse outcomes such as infection, bladder overdistention injury, recatheterization, urinary retention, and patients discharged with indwelling catheter were evaluated. The incidence of CAUTI and the total number of catheter days pre and post policy change were similar. The incidence rate of urinary retention and associated complications has increased since the policy changed. Practices intended to reduce the CAUTI rate are associated with unintended complications, such as urinary retention. Patient safety and quality improvement programs should monitor all complications associated with urinary catheterization practices, not just those that represent financial penalties.

Effective Perioperative Communication to Enhance Patient Care

Breakdowns in health care communication are a significant cause of sentinel events and associated patient morbidity and mortality. Effective communication is a necessary component of a patient safety program, which enables all members of the interdisciplinary health care team to effectively manage their individual roles and responsibilities in the perioperative setting; set expectations for safe, high-reliability care; and measure and assess outcomes. To sustain a culture of safety, effective communication should be standardized, complete, clear, brief, and timely. Executive leadership and support helps remove institutional barriers and address challenges to support the engagement of patients in health care communication, which has been shown to improve outcomes, reduce costs, and improve the patient experience.

Department of Veterans Affairs Chief Resident in Quality and Patient Safety Program: A Model to Spread Change.

Department of Veterans Affairs Chief Resident in Quality and Patient Safety Program: A Model to Spread Change.

SU‐D‐201‐07: A Survey of Radiation Oncology Residents’ Training and Preparedness to Lead Patient Safety Programs in Clinics

Purpose:Safety and quality has garnered increased attention in radiation oncology, and physicians and physicists are ideal leaders of clinical patient safety programs. However, it is not clear whether residency programs incorporate formal patient safety training and adequately equip residents to assume this leadership role. A national survey was conducted to evaluate medical and physics residents’ exposure to safety topics and their confidence with the skills required to lead clinical safety programs.Methods:Radiation oncology residents were identified in collaboration with ARRO and AAPM. The survey was released in February 2016 via email using REDCap. This included questions about exposure to safety topics, confidence leading safety programs, and interest in training opportunities (i.e. workshops). Residents rated their exposure, skills, and confidence on 4 or 5‐point scales. Medical and physics residents responses were compared using chi‐square tests.Results:Responses were collected from 56 of 248 (22%) physics and 139 of 690 (20%) medical residents. More than two thirds of all residents had no or only informal exposure to incident learning systems (ILS), root cause analysis (RCA), failure mode and effects analysis (FMEA), and the concept of human factors engineering (HFE). Likewise, 63% of residents had not heard of RO‐ILS. Response distributions were similar, however more physics residents had formal exposure to FMEA (p&lt;0.0001) and felt they were adequately trained to lead FMEAs in clinic (p&lt;0.001) than medical residents. Only 36% of residents felt their patient safety training was adequate, and 58% felt more training would benefit their education.Conclusion:These results demonstrate that, despite increasing desire for patient safety training, medical and physics residents’ exposure to relevant concepts is low. Physics residents had more exposure to FMEA than medical residents, and were more confident in leading FMEA. This suggests that increasing resident exposure to specific topics may increase their confidence.

The WakeWings Journey: Creating a Patient Safety Program

AORN JournalVolume 103, Issue 6 p. 636-639 Column The WakeWings Journey: Creating a Patient Safety Program Elizabeth Mills MSN, RN, CNOR, CSSM, Elizabeth Mills MSN, RN, CNOR, CSSMSearch for more papers by this author Elizabeth Mills MSN, RN, CNOR, CSSM, Elizabeth Mills MSN, RN, CNOR, CSSMSearch for more papers by this author First published: 25 May 2016 https://doi.org/10.1016/j.aorn.2016.04.004 Editor's note: The Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery is a trademark of The Joint Commission, Oakbrook Terrace, IL. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Volume103, Issue6June 2016Pages 636-639 RelatedInformation

Performance improvement and patient safety program-guided quality improvement initiatives can significantly reduce computed tomography imaging in pediatric trauma patients.

Morbidity and mortality of cervical spine (C-spine) injury in pediatric trauma patients are high, necessitating quick and accurate diagnosis. Best practices emphasize minimizing radiation exposure through decreased reliance on computed tomography (CT), instead using clinical assessment, physical examination, and alternate imaging techniques. We implemented an institutional performance improvement and patient safety (PIPS) program initiative for C-spine clearance in 2010 because of high rates of CT scans among pediatric trauma patients. A retrospective review of pediatric trauma patients, aged 0 years to 14 years, in the pre- and post-PIPS implementation periods was conducted. Rates of C-spine CT, overall CT, other imaging modalities, radiation exposure, patient characteristics, and injury severity were compared, and compliance with PIPS protocol was reviewed. Patient characteristics and injury severity were similar before and after PIPS implementation. C-spine CT rates decreased significantly between groups (30% vs. 13%, p < 0.001), whereas C-spine plain x-ray rates increased significantly (7% vs. 25%, p < 0.001). There was no difference in C-spine magnetic resonance imaging between groups (12% vs. 10%, p = 0.11). In 2007, 71% of patients received a CT scan for any reason. However, the overall CT rate decreased significantly between groups (60% vs. 45%, p < 0.001). There was an estimated 22% decrease in lifetime attributable risk (LAR) for any cancer due to ionizing imaging exposure in males and 38% decrease in females between the pre- and post-PIPS groups. There was a 54% decrease in LAR for thyroid cancer in males and females between groups; 2014 compliance with the protocol was excellent (82-90% per quarter). Performance improvement and patient safety program-generated protocol can significantly decrease ionizing radiation exposure. We demonstrate that a simple protocol focused on C-spine imaging has high compliance, decreased C-spine CT scans, and decreased LAR for thyroid cancer. A secondary benefit is a reduction in total CT imaging, with an associated decrease in LAR for all cancers. Therapeutic study, level IV; diagnostic study, level III.

Patient safety and nursing implication: Survey in Catalan hospitals.

This study aims to describe the implementation of the patient safety (PS) programs in catalan hospitals and to analyze the level of nursing involvement. Multicenter cross-sectional study. To obtain the data two questionnaires were developed; one addressed to the hospital direction and another to the nurse executive in PS. The survey was distributed during 2013 to the 65 acute care hospitals in Catalonia. The questionnaire was answered by 43 nursing directors and 40 nurse executive in PS. 93% of the hospitals responded that they had a PS Program and 81.4% used a specific scoreboard with PS indicators. The referent of the hospital in PS was a nurse in 55.8% of the centres. 92.5% had a system of notification of adverse effects with an annual average of 190.3 notifications. In 86% of the centres had a nurse involved in the PS program but only in the 16% of the centres the nurse dedication was at full-time. The nurse respondents evaluate the degree of implementation of the PBS program with a note of approved and they propound as improvement increase the staff dedicated to the PS and specific academic training in PS. The degree of implementation of programs for patient safety is high in Catalan acute hospitals, while the organizational structure is highly diverse. In more than half of the hospitals the PS referent was a nurse, confirming the nurse involvement in the PS programs.

Infective endocarditis in patients on haemodialysis – possible strategies for prevention

Infective endocarditis is an important cause of morbidity and mortality in patients receiving haemodialysis for established renal failure. We carried out a prospective audit of patients developing infective endocarditis in a single renal unit. From 1 January 2000 to 31 December 2013, we collected data on all cases of endocarditis occurring in patients receiving haemodialysis at Monklands Hospital, Airdrie. Twenty-nine patients developed endocarditis during our audit period. Twenty-three (79.3%) of the patients had pre-existing cardiac valve abnormalities such as regurgitation or calcification. Staphylococcus aureus was the most common microorganism cultured from the blood of 22 patients (75.9%). MRSA bacteraemia was identified in eight of these patients and all eight patients died during that first presentation. Different strategies were introduced within the unit during the audit period aiming to reduce the rate of bacteraemia. Since 2011, a successful strategy has been introduced under the auspices of the Scottish Patient Safety Programme. This led to our Staph aureus bacteraemia rate related to non-tunnelled venous catheters going from an average of 15 days between episodes to having had no episodes between 2 December 2011 and the end of the study period (760 days). This also appears to have had a positive impact on reducing the rate of endocarditis. Infective endocarditis remains a devastating consequence of bacteraemia in patients receiving haemodialysis. An effective strategy aimed at reducing the rate of bacteraemia appears to have a similar effect on the rate of endocarditis.

Results from the National Perinatal Patient Safety Program in Sweden: the challenge of evaluation.

We studied the effects of the national Perinatal Patient Safety Program in Sweden, addressing local improvement measures, changes in the proportion of low Apgar score and the number of settled injury claims due to asphyxia. Final reports on achieved improvements from all Swedish obstetric units were analyzed and categories of the improvement measures taken in perinatal risk areas were established. Data on all term newborns during 2006-12 were obtained from the Medical Birth Registry. Incidence of 5-min Apgar score <7 was analyzed before, during and after the intervention. The odds ratio for low Apgar score in period ÍII vs. period I was calculated. Patient injury claims from The Swedish National Patient Insurance Company (LÖF) were analyzed. Numerous local improvement initiatives were reported. The incidence of 5-min Apgar score <7 on a national level remained unchanged during the study periods. The units with the highest rate of Apgar score <7 showed a significant decrease in Apgar score of 4-6 after the intervention, whereas units with the lowest rate of Apgar score <7 showed a significant increase in Apgar score <7 after the intervention. A decline in settled claims due to substandard care was observed (7.5%, 2012-14; p for trend 0.049). The national incidence of low Apgar score remained unchanged but a reduction of settled claims of severely asphyxiated neonates was observed. The study highlights the need for robust designs when evaluating large-scale initiatives for improving patient safety at delivery, along with the difficulties in performing them.