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has developed a taxonomy for medication errors for the recording and tracking of errors. General reporting programs (not specific to medications) include JCAHO's sentinel events reporting program and some state programs.

3. "State Agency Experiences Regarding Mandatory Reporting of Sentinel Events," JCAHO draft survey results, April 1999.

4. Billings, Charles, "Incident Reporting Systems in Medicine and Experience With the Aviation Safety Reporting System," in Cook, Richard; Woods, David; and Miller, Charlotte, A Tale of Two Stories: Contrasting Views of Patient Safety, Chicago: National Patient Safety Foundation of the AMA, 1998.

5. Office of the Inspector General, "The External Review of Hospital Quality: A Call for Greater Accountability," http://www.dhhs.gov/progorg/oei/reports/oei-01-97-00050.htm.

6. Additional strategies include field investigations, epidemiological studies and other focused studies.

7. "Sentinel Event Policy and Procedure," Revised: July 18, 1998. Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, Illinois.

8. Joint Commission on Accreditation of Healthcare Organizations, Sentinel Event Alert, Number Three, May 1, 1998.

9. Heigel, Fred, presentation at 12th Annual State Health Policy Conference, National Academy for State Health Policy, Cincinnati, Ohio, August 2, 1999.

10. "Federal Aviation Administration, Office of System Safety, Safety Data," http://nasdac.faa.gov/safety_data.

11. Billings, Charles, "Incident Reporting Systems in Medicine and Experience With the Aviation Safety Reporting System," Appendix B in A Tale of Two Stories, Richard Cook, David Woods and Charlotte Miller, Chicago: National Health Care Safety Council of the National Patient Safety Foundation at the AMA, 1998.

12. Federal Aviation Administration, "Aviation Safety Action Programs (ASAP)," Advisory Circular No. 120-66, 1/8/97.

13. "All About OSHA," U.S. Department of Labor, Occupational Safety and Health Administration, OSHA 2056, 1995 (Revised).

14. Brewer, Timothy and Colditz, Graham A. Postmarketing Surveillance and Adverse Drug Reactions, Current Perspectives and Future Needs. JAMA. 281(9):824–829, 1999. See also: FDA, "Managing the Risks from Medical Product Use, Creating a Risk Management Framework," Report to the FDA Commissioner from the Task Force on Risk Management, USDHHS, May, 1999.

15. Billings, Charles, presentation to Subcommittee on Creating an External Environment for Quality Health Care, January 29, 1999.

16. Brewer and Colditz, 1999. See also: FDA, "Managing the Risks from Medical Product Use," May 1999.

17. FDA, "Managing the Risks from Medical Product Use," May 1999.

18. As part of the FDA Modernization Act of 1997, the FDA is mandated to shift from a universal mandatory reporting system for users (hospitals and nursing homes) of medical devices to one where only a subset of facilities report. In their pilot test, they believed that faster and better feedback to reporters contributed to improved reporting. FDA, May 1999. See also: Susan Gardner, Center for Devices and Radiological Health, personal communication, November 24, 1998.



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