Quality Management Department Occurrence /

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Description: Quality Management Department Occurrence Variance Reporting Management Definition and Classification Occurrences An event or circumstance that harmed or has the potential to harm a person or a property in relation to the organization,

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slide1. Quality Management Department Occurrence / Variance Reporting & Management<br>
slide2. Definition and Classification Occurrences
An event or circumstance that harmed or has the potential to harm a person or a property in relation to the organization, resulting from human behavior and /or system failure.
Variances
A circumstance considered not within the standard routine operation/care or involving inconsistencies with approve written hospital policies and procedures, protocol, guideline, standard operating procedure, standard of care, etc.
Near Miss “Close Call , Good Catch”
An event with the potential for harm that did not result in harm because it did not reach the individual due to timely intervention or good fortune.<br>
slide3. Definition and Classification Adverse Event
An event that results in unintended harm to the patient, and is related to the care and/or services provided to the patient rather than to the patients underlying medical condition, e.g. HAIs, Patient Fall, Pressure Ulcer, etc.
Patient Safety Mandatory Reportable Events
Refers to a subset of patient safety adverse events that must be reported in the Ministry of Health electronic system and are defined as serious patient safety occurrences.
Sentinel Event
Is any event leading to serious patient harm or death and is caused by healthcare rather than the patient’s underlying illness.<br>
slide4. Definition and Classification Adverse Drug Event
Is an injury resulting from medical intervention related to a drug. This includes medication errors, adverse drug reactions, allergic reactions, and overdoses.
Adverse Drug Reaction
A response to a drug that is noxious and unintended and occurs at doses normally used for the prophylaxis, diagnosis, or therapy of disease or for modification of physiological function..
Just Culture
A culture in which frontline personnel are comfortable disclosing errors, including their own, while maintaining professional accountability, recognizing individual practitioners should not be held accountable for system failings over which they have no control, yet does not tolerate conscious disregard of clear risks to patients or gross misconduct.<br>
slide5. Definition and Classification Root Causes Analysis (RCA)
It is an analytic tool that can be used to perform a comprehensive, system based review of critical occurrences/variances. It includes the identification of the underlying reason and contributory factors, identification or risk reduction strategies, and development of action plans along with measurement strategies, to evaluate the effectiveness of the plans.
Disclosure
The process by which an adverse event or event is communicated to the patients/families or their authorized legal representatives by healthcare providers<br>
slide6. SAUDI CBAHI STANDARDS QM.14. The hospital has an incident (occurrence/variance) management mechanism that supports improvements of care processes.<br>
slide7. Policy Statement All occurrences/variances when identified shall be immediately managed in accordance with the procedures outlined in this Policy and shall ensure the health and safety of those affected are the primary focus of attention.
In any safety event where harm reached the patient, appropriate disclosure shall be given to the patient and/or their families. Patients and their families are entitled at all times to truthful and transparent communication and explanation of any safety events happening to them.
All staff must receive orientation, education and training on the OVR policy and procedure.<br>
slide8. Policy Statement The OVR E-Form shall not be used to criticize or speculate on actions of the staff involved. State only facts not your personal opinions.
The information contained in the OVR cannot and shall not be used against any individual as the sole basis for disciplinary action.
If a patient is involved in occurrences/variances, the OVR shall not be recorded in the patient Medical Record. However, assessment, investigation, and treatments shall be documented in the patient medical record.
All information resulted from investigation shall be documented in the OVR system.
During system downtime, paper-based OVR forms shall be used
All information related to OVR must be kept confidential and retained in a locked cabinet (paper based) and in the OVR System for a period of three (3) years under the responsibility of Quality Management Department (QMD).<br>
slide9. Who should report?<br>
slide10. What to report?<br>
slide11. Work-Related Injury and disease An injury or disease that occurs on the job as a direct result of duties assigned to the specific job position.<br>
slide12. Sentinel Event Is any event leading to serious patient harm or death and is caused by healthcare rather than the patient’s underlying illness.<br>
slide13. Chief Officer Concerned shall ensure obligations and requirements for reporting Occurrence/Variances to governmental agencies such as Central Board of Accreditation for Health Care Institution (CBAHI), Ministry of Health (MOH), Saudi Food and Drug Authority (SFDA) and/or Riyadh Civil Defense are completed as appropriate.

Sentinel Events must be reported to CBAHI within (5) working days of the internal notification of the event. Root Cause Analysis (RCA) with a risk reduction action plan must be submitted to CBAHI within (30) working days .

Sentinel Events must be reported to Ministry of Health (MOH) within 48 hours of the internal notification of the event. Notification to External Agencies<br>
slide14. SAUDI PATIENT SAFETY TAXONOMY<br>
slide15. Occurrence / Variance Reporting Flowchart<br>