Safety Learning Report

CHILDREN S HOSHTALS AND CLINICS OFFICE OF PATIENT SAFETY 

The information you report is generated and maintained for quality improvement purposes under Minnesota Statute 145.61 et seq and is confidential under that statue. 

Accident/Near miss/System breakdown/ Good catch/How safety was created/ Hazardous situation/Accident wait/Happen/ Normalization of deviance 

Addressograph or name/medical record /DOB/account number 

MEDICATIONS INVOLVED (include med name, admin route) 

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Like the ASRS form, the Children s Hospitals and Clinics safety learning report asks the reporter an open-ended question about the incident "What happened " There is ample room for a written response. The reporter then clicks through to a new screen and is prompted with additional questions ... 

Sharing the Knowledge from Safety Learning Reports... 

As implied by its title, the safety update report is not submitted with the original BLA, but is submitted in the form of updates at specific points in the application review process. Applicants must submit safety update reports 4 months after the BLA submission, after receipt of a complete response letter, and other times requested by CBER. In these reports, the sponsor must update the pending BLA with new safety information learned about the product that may reasonably affect the labeling statements in the contraindications, warnings, precautions, and adverse reactions sections. The updates must include the same types of information from clinical studies, animal studies, and other sources, and must be submitted in the same format as the BLA s integrated safety summary. They must also include case report forms for each patient who died during a clinical study or who did not complete the study because of an adverse event. 

The UK national patient safety agency reporting and learning system... 

Lessons learned stimulate imagination and prompt ideas for improving safety as reports are gathered and analyzed, and lessons learned are reported back to the organization. Feedback and communication nurture the safety culture, and the safety culture in turn cultivates and improves the reporting system (see Figure 6.3). 

D. Abramowitz, Response to DCHAS-L Inquiry Glassware injury lesson learned report , American Chemical Society, Division of Chemical Health and Safety, DCHAS-L ListServe, July 2, 2015 at 12 13 pm. 

Tlie DOE Office of Environmental Safety and Health distributes monthly summaries ba.scd on data retreived from the DOE Occurrence Reporting and Processing System (ORPS) to share chemical safety concerns throughout the industry to alert operators of similar processes. In addition quarterly and annual reviews feature lessons learned from ORPS by trending analyses of ini an... 

Develop and implement a program for reporting reactive incidents that includes the sharing of relevant safety knowledge and lessons learned with your membership, the public, and government to improve safety system performance and prevent future incidents. 

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