DHS Adverse Event Reporting Requirements

1. DHS Adverse Event Reporting Requirements With Associated Revisions to the UCLA Event Reporting System Presented by the Quality Resource Department June 6, 2007

2. Senate Bill 1301 • Added sections to the Health and Safety Code mandating California hospitals report “Never 27 Adverse Events” to DHS • “Never 27 Adverse Events” is a list of serious reportable events in health care that should never occur • Reporting effective July 1, 2007

3. Adverse Event Reporting to DHS • Specific adverse events must be reported to DHS within 5 days of discovery and within 24 hours if the adverse event is an ongoing urgent or emergent threat to the safety of patients, staff, or visitors • DHS will assess fines if the event is not reported in the defined time frame

4. Process for Reporting DHS Adverse Events 2. Adverse Event Reported in Event Reporting System 1. Adverse Event Occurs 3. Email Automatically Sent to DHS Coordinator with Link to Event Report 4. Investigation into Adverse Event and Reported to DHS if Appropriate

5. Surgical Events • Surgery performed on a wrong body part • Surgery performed on the wrong patient • Wrong surgical procedure performed

6. Surgical Events • Unintentional retention of foreign object in a patient after surgery or other procedure

7. Surgical Events • Unexpected death during anesthesia or within 24 hours after induction of anesthesia

8. Product or Device Events • Patient death/serious disability associated with the use of a contaminated drug/device or biologic

9. Product or Device Events • Patient death/serious disability associated with the use/function of a device in ways other than intended – catheter, drain, or other specialized tube, infusion pump, or ventilator

10. Product or Device Events • Patient death/serious disability associated with intravascular air embolism (excluding certain neurosurgical procedures)

11. Patient Protection Events • An infant discharged to the wrong person

12. Patient Protection Events • Patient death/serious disability associated with patient disappearance for more than four hours (excluding adults with capacity)

13. Patient Protection Events • Patient suicide or attempted suicide while being cared for in a health facility resulting in serious disability

14. Care Management Events • Death/serious disability associated with a medication error

15. Care Management Events • Death/serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products

16. Care Management Events • Maternal death/serious disability associated in low-risk pregnancy (including 42 days post delivery) – excluding deaths from pulmonary/amniotic fluid embolism, acute fatty liver of pregnancy, cardiomyopathy

17. Care Management Events • Death/serious disability directly related to hypoglycemia onset in hospital

18. Care Management Events • Death/serious disability associated with failure to identify and treat hyperbilirubinemia in neonates during the first 28 days of life

19. Care Management Events • Stage 3 or 4 ulcer acquired after admission (excluding progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission)

20. Care Management Events • Death/serious disability due to spinal manipulation at hospital

21. Environmental Events • Patient death/serious disability associated with an electric shock (excluding planned treatments)

22. Environmental Events • Any incident where line designated for oxygen or other gas contains wrong gas or is contaminated by toxic substance

23. Environmental Events • Patient death/serious disability associated with a burn incurred from any source while being cared for in a health care facility

24. Environmental Events • Patient death/serious disability associated with a fall

25. Environmental Events • Patient death/serious disability associated with the use of restraints or bedrails

26. Criminal Events • Care ordered or provided by someone impersonating a licensed health care provider

27. Criminal Events • Abduction of a patient of any age

28. Criminal Events • Sexual assault of a patient

29. Criminal Events • Death or significant injury of a patient or staff member resulting from physical assault

30. “Never Event 28” • An adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor.

31. What’s Next? • Staff education provided regarding new reporting requirements • Revisions to Event Reporting System “go live” June 15th • Reporting to DHS effective July 1, 2007 • January 1, 2009 – Information will be made readily accessible to consumers about substantiated adverse events and investigation outcomes • January 1, 2015 – Substantiated adverse events and investigation outcomes will be available on the DHS website