METHODS: An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.
RESULTS: All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders.
CONCLUSIONS: We identified the diversification in terminology and code selection for reporting MDAEs.
DESIGN/METHODOLOGY/APPROACH: Using difference in differences model, BIMC Hospitals and Siloam Hospital Bali were compared before and after shift schedule realignment to test the association between shift schedule realignment and patient safety culture.
FINDINGS: Shift schedule realignment was associated with a significant improvement in staffing (coefficient 1.272; 95% CI 0.842 - 1.702; p<0.001), teamwork within units (coefficient 1.689; 95% CI 1.206 - 2.171; p<0.001), teamwork across units (coefficient 1.862; 95% CI 1.415 - 2.308; p<0.001), handoffs and transitions (coefficient 0.999; 95% CI 0.616 - 1.382; p<0.001), frequency of error reported (coefficient 1.037; 95% CI 0.581 - 1.493; p<0.001), feedback and communication about error (coefficient 1.412; 95% CI 0.982 - 1.841; p<0.001) and communication openness (coefficient 1.393; 95% CI 0.968 - 1.818; p<0.001).
PRACTICAL IMPLICATIONS: With positive impact on patient safety culture, shift schedule realignment should be considered as quality improvement initiative. It stretches the compressed workload suffered by staff while maintaining 40 h per week in accordance with applicable laws and regulations.
ORIGINALITY/VALUE: Shift schedule realignment, designed to improve patient safety culture, has never been implemented in any Indonesian private hospital. Other hospital managers might also appreciate knowing about the shift schedule realignment to improve the patient safety culture.
DESIGN: Quasi-experimental study consisting of a single group before-and-after study design.
SETTING: A public emergency hospital in Mecca, Saudi Arabia.
PARTICIPANTS: 660 (preintervention) and then 498 (postintervention) handwritten physician orders, medication administration records (MRAs) and pharmacy dispensing sheets of 482 and 388 patients, respectively, from emergency wards, inpatient settings and the pharmacy department were reviewed.
INTERVENTION: The intervention consisted of a series of interactive lectures delivered by an experienced clinical pharmacist to all hospital staff members and dissemination of educational tools (flash cards, printed list of HRAs, awareness posters) designed in line with the recommendations of the Institute for Safe Medical Practices and the US Food and Drug Administration. The duration of intervention was from April to May 2011.
MAIN OUTCOME: Reduction in the incidence of HRAs use from the preintervention to postintervention study period.
FINDINGS: The five most common abbreviations recorded prior to the interventions were 'IJ for injection' (28.6%), 'SC for subcutaneous' (17.4%), drug name and dose running together (9.7%), 'OD for once daily' (5.8%) and 'D/C for discharge' (4.3%). The incidence of the use of HRAs was highest in discharge prescriptions and dispensing records (72.7%) followed by prescriptions from in-patient wards (47.3%). After the intervention, the overall incidence of HRA was significantly reduced by 52% (ie, 53.6% vs 25.5%; p=0.001). In addition, there was a statistically significant reduction in the incidence of HRAs across all three settings: the pharmacy department (72.7% vs 39.3%), inpatient settings (47.3% vs 23.3%) and emergency wards (40.9% vs 10.7%).
CONCLUSIONS: Pharmacist-led educational interventions can significantly reduce the use of HRAs by healthcare providers. Future research should investigate the long-term effectiveness of such educational interventions through a randomised controlled trial.
METHODS: A questionnaire based on the Joint Commission International Accreditation Standards was electronically sent to 3 institutions each in 10 geographical regions across 9 Asian countries. Questions addressing 45 practices were divided into 3 categories. A five-tier scale with numerical scores was used to evaluate safety practices in each institution. Responses obtained from three institutions in the United States were used to validate the execution rate of each surveyed safety practice.
RESULTS: The institutional response rate was 70.0% (7 Asian regions, 21 institutions). 44 practices (all those surveyed except for the application of wrist tags for identifying patients with fall risks) were validated using the US participants. Overall, the Asian participants reached a consensus on 89% of the safety practices. Comparatively, most Asian participants did not routinely perform three pre-procedural practices in the examination appropriateness topic.
CONCLUSION: Based on the responses from 21 participating Asian institutions, most routinely perform standard practices during radiological examinations except when it comes to examination appropriateness. This study can provide direction for safety policymakers scrutinizing and improving regional standards of care.
ADVANCES IN KNOWLEDGE: This is the first multicenter survey study to elucidate pre-procedural safety practices in radiological examinations in seven Asian regions.
DESIGN: We conducted a multi-country cross-sectional study.
METHODS: Following a literature review and patient focus groups, an expert panel generated questionnaire items. Following a pilot study, item numbers were reduced. The final questionnaire consisted of three sections: demographics, perceived QoC and one open-ended question. Data was collected from patients (n = 531) discharged from hospitals across seven countries in South East Europe (languages: Turkish, Greek, Portuguese, Romanian, Croatian, Macedonian and Bulgarian). Reliability and validity of the measure were assessed.
RESULTS: Confirmatory factor analysis was used to compare various factor models of patient-perceived QoC. Good model fit was demonstrated for a two-factor model: communication and interpersonal care, and hospital facilities.
CONCLUSIONS: The ORCAB (Improving quality and safety in the hospital: The link between organisational culture, burnout and quality of care) Patient QoC questionnaire has been collaboratively and exhaustively developed between healthcare professionals and patients. It enables patient QoC data to be assessed in the context of the IOM pillars of quality, considering both technical and interpersonal dimensions of care. It represents an important first step in including the patient perspective.