1. Clinical risk management Open Disclosure

2. Controlling Unpredictability of health Laws Civil law Parliamentary law & statues Client rights Professional standards Nursing Boards Nurse patient relationship Clinical standards GCP Organizational policies and protocols Ethics

3. Clinical Risk Management Nurses in all levels and areas of practice have a stringent responsibility to reduce and where possible prevent the incidence and impact of preventable adverse events in health care We need to move away from ‘name, blame, shame’ attitude.

4. Human Error: models and management The person approach The system approach

5. The person approach Focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness Focuses on the unsafe acts: error and procedural variations Followers of this approach tend to treat errors as moral issues, assuming bad things happen to bad people Reason, J 2000

6. The system approach Concentrates on the conditions under which individuals work and tries to build defences to aver errors or reduce their effects The basic premise is that humans are fallible and errors are to be expected, even in the best organizations. Errors are consequences, due to systemic factors

7. The system approach The central idea is that of system defences. When an adverse event occurs, the important issue is not who blundered, but how and why the defences failed Reason, J 2000

8. Adverse Event An untoward incident, therapeutic misadventure, iatrogenic injury, or other adverse occurrence directly associated with care or services provided within the jurisdiction of health care service Undesired patient outcomes that may or may not be the result of errors

9. Sentinel Events Are unexpected occurrences involving: Death Major or permanent loss of function (sensory, motor, physiologic or intellectual impairment not present and the time of admission) AND Associated with the treatment, lack of treatment, or delay in treatment.

10. Australian Sentinel Events Procedures involving the wrong patient or body part Suicide Retained instruments or other material requiring further surgical procedure Intravascular gas embolism resulting in death or neurological damage

11. Australian Sentinel Events Haemolytic blood transfusion Medication error leading to death Maternal death or serious morbidity associated with labour or delivery Infant abduction or discharge to the wrong family.

12. Root causes of medication errors Communication Orientation/ training Standardization Availability of information Staffing levels Competence Supervision Storage/ access Labeling Distraction

13. Action following and adverse event Local management and investigation Root cause analysis Aggregated reviews Root cause analysis is not conducted if there has been a suspected criminal act. It is important to report near misses By not communicating and sharing adverse events there is a chance the event will be repeated.

14. Topic 05 Open Disclosure (OD) “ Oh Dear “!!!

15. The introduction Open Disclosure It also includes providing feedback on investigations including the steps taken to prevent an even from recurring. It is also about providing information that will enable systems of care to be changed to improves patient safety

16. Definition of OD Process of Open discussion on Adverse event or outcomes between the healthcare professionals and the healthcare consumers” Adverse event is “ Unintended or intentional harm or suffering caused by any aspect of healthcare management” Preventive, investigative, curative, rehabilitative - Australian patient safety foundation-

17. Reasons for Adverse events System errors Human errors

18. System errors Methods – Lack of or inadequacy of Policies & protocols Supervision - Supervisory / management decisions Resources – Inadequacy or lack of recourses Human Equipments space supplies

19. Human errors Knowledge Understanding Non qualification Skill Implementing methods/ procedures Technical incompetency Experience Attitude

20. Key principles of OD Openness and timelines of communication Acknowledgement of error and expression of regret Recognition of the reasonable expectations of the consumer Confidentiality Support for health staff

21. What is the process of Open Disclosure High level of responseLow level of response Step 03 Identification of the consequence Step 02 Immediate prevention of the further ham / AE Step 01 Identification of the harm/ Adverse Event

22. Level of response High level of response Low level of response

23. High Level of response Consequence All of these not related to the patients existing condition such as ; Death / major permanent loss of function Lessening of function Needs a higher level of care Action Immediate notification to the manager of clinical risk Disclosure process by senior healthcare professional In-depth investigation and feed back

24. Examples Unexpected return to theatre Fall out of bed resulting in fracture Delayed or missed diagnosis causing permanent injury or requiring increased level of care Suicide

25. Low Level of response Consequence All of these not related to the patients existing condition such as No permanent loss of function No Need of a higher level of care Action Local management Incident report Disclosure process by senior healthcare professional

26. Examples Fall out of bed with no injury sustained Medication error with no permanent injury or increased level of care required Incorrect diagnostic test performed

27. Who is responsible for open disclosure process Experience staff nurse Senior physician

28. Case studies on OD

29. Thank you !