Adverse event reporting.pdf

More documents

Recommendations

Info

Expert analysis Whether analysing relatively simple reports to identify and understand new hazards, or searching for common underlying contributing factors in serious adverse events, all reporting systems need experts who understand the content and context of reported events. Experts determine whether reports are for identifying trends only, require follow-up with the reporter for further information, should trigger an on-site investigation, or herald an emerging hazard that warrants alerting the health-care organizations. To provide meaningful recommendations, it is necessary to have experts who understand the practice concerns, clinical significance, systems issues, and potential preventive measures for the problems raised by the reports. Ultimately, it is human experts who must translate the knowledge gleaned from aggregated reports into meaningful recommendations for action to improve care. Capacity to disseminate findings and recommendations To fulfill their mission, reporting systems must communicate back to the community from which the reports are received. Reports, newsletters, communications, or alerts distill the meaning of aggregated reports into meaningful themes, identify proposed actions to prevent harm, inform policy-makers of issues, broadcast solutions and best practices, or alert pharmaceutical companies, device manufacturers, or health-care providers to new hazards. This requires staff to write reports and a mechanism to disseminate reports, such as large-scale mailings, press releases, newsletters, or electronic bulletins. At a higher level, findings from the reporting system inform new safety initiatives that are generated and implemented by the appropriate authority. The National Reporting and Learning System of England and Wales, for example, feeds information and recommendations to the National Patient Safety Agency, which develops initiatives and campaigns to implement solutions. While ultimately the effectiveness of a reporting system is measured by improvements in clinical outcomes, an intermediary measure is the number of recommendations generated from analyses of reports. Security issues Whereas reports within a health-care organization often have rich detail and usually contain information that makes it possible to identify the people concerned, it is important that such information is removed from external reports and de-identified to protect patients, providers and reporters. Confidentiality protection against unauthorized access must be implemented with a data security system. This may include a process for de-identifying reports upon their receipt or after a follow-up
investigation has occurred. A lock box or “firewall” may be indicated to protect against inadvertent data sharing with other parties or agencies. Data encryption methods are essential for web-based reporting systems. Data security systems also should have a mechanism for identifying breaches of security.
Page 2 and 3:
WHO/EIP/SPO/QPS/05.3 © World Healt
Page 4 and 5:
ACKNOWLEDGEMENTS WHO wishes to ackn
Page 7: TABLE OF CONTENTS 1. INTRODUCTION .
Page 10 and 11: The guidelines draw on a review of
Page 12 and 13: nursing practice standards to label
Page 14 and 15: 2. THE ROLE OF REPORTING IN ENHANCI
Page 16 and 17: ous contributing factors that lead
Page 18 and 19: 3. COMPONENTS OF A REPORTING SYSTEM
Page 20 and 21: The Netherlands has a two-tiered pr
Page 22 and 23: dosage (7). Adverse drug reactions
Page 24 and 25: A higher level of structured report
Page 26 and 27: scales and definitions; these are o
Page 28 and 29: Analysis Hazard identification At a
Page 30 and 31: the outcome. For example, regressio
Page 32 and 33: 4. ALTERNATIVE SOURCES OF INFORMATI
Page 34 and 35: Medical record review Medical recor
Page 36 and 37: and solutions. Observation can also
Page 38 and 39: y a central oversight authority wit
Page 40 and 41: A major issue for all reporting sys
Page 42 and 43: What is reported: Patient safety in
Page 44 and 45: Ireland Type of reporting system: T
Page 46 and 47: Private and non-government initiate
Page 48 and 49: Who reports: Reports are received f
Page 50 and 51: during accreditation survey. The JC
Page 52 and 53: Non-punitive. The most important ch
Page 54 and 55: References 1. 2. 3. 4. 5. 6. 7. Coh
Page 56 and 57: of quality improvement and error pr
Page 60 and 61: 8. RECOMMENDATIONS TO WHO MEMBER ST
Page 62 and 63: will be referenced to illustrate se
Page 64 and 65: highlighting a single element as th
Page 66 and 67: Latent errors pose the greatest thr
Page 68 and 69: • a set of processes that identif
Page 70 and 71: Another aspect of making systems mo
Page 72 and 73: Where processes may have been monit
Page 74 and 75: and the use of simulators for train
Page 76 and 77: 32. Cook and Woods, 1994. 33. Reaso
Page 78: 7. What is the data infrastructure?
show all

Adverse event reporting.pdf

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?