INSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section:
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1 HOSPITAL NAME INSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section: TITLE/DESCRIPTION POLICY NUMBER OCCURRENCE VARIANCE REPORT SYSTEM EFFECTIVE DATE REVIEW DUE REPLACES NUMBER NO. OF PAGES APPROVED BY APPLIES TO PURPOSE To provide a systematic, standardized hospital-wide mechanism to identify and/or to develop prevention /improvement programs which have direct or indirect adverse effect on patient care; and which represent a potential hazard to patients, visitors, volunteers, trainees, employees or the facility as quality improvement approach. OVR shall be used as a mechanism for monitoring, Quality Improvement in a Non Punitive Approach. DEFINITION 1. An Occurrence: any occurrence that is not consistent with the routine operation which happens at the premises, Housing (owned, lease), external Activities, and transportation or whenever there is an unusual or unexpected response by a patient to standard treatment or medical intervention, any routine operation that adversely affects or threatens the health or life of patient, visitor, employee, trainee or volunteer; or which involves loss or damage to personal or Hospital property. An occurrence also includes any event might result in any other adverse situation that violates the code of conduct or a claim against the organization. 2. Occurrence Variance Report (OVR): an internal form used to document the details of the occurrence/event and the investigation of an occurrence and the corrective actions taken. 3. On-the-job Occurrence: an occurrence that takes place in the Hospital or outside the premises when the employee is carrying out his/her duties, such as Home Health care staff. 4. Adverse Drug/Instrument Event: any occurrence in which the use of medication (drug or biologic) at any dose, a medical device, improper administration of medications or a special nutritional product (for example dietary supplement, infant formula, medical food) may have resulted in an adverse outcome in a patient. 5. Adverse Event: are unexpected incidents, therapeutic misadventures, iatrogenic injuries or other adverse occurrences directly associated with care or services provided. Adverse events can be categorized as either a sentinel event or near miss that results from acts of commission or omission (e.g. administration of the wrong medication, failure to make a timely diagnosis or institute the appropriate therapeutic intervention, adverse reactions or negative outcomes of treatment, etc.). Some examples of adverse events include: patient falls, medication errors, procedural errors/complications, completed suicides, para suicidal behaviors (attempts/gestures/threats), and missing patient events. 6. Sentinel Event: A Sentinel Event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof, not related to the natural course of a patient s illness or underlying condition. The phrase serious physical or psychological injury specifically includes loss of limb or function. The phrase or the risk thereof includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome and includes delays in diagnosis and treatment. The following events are considered Sentinel Events even if the outcome is not death or major permanent loss of function: Suicide Standards Page 1 of 5
2 Homicide Surgery on the wrong patient or body part Impairment (major/permanent loss of bodily function i.e. serious physical or psychological injury or the risk thereof) that is not the result of the patient s underlying medical condition. Any unexpected death that is not the result of the patient s underlying medical condition Rape Child Abduction or discharge to the wrong family Hemolytic Blood Transfusion 7. Near Miss: Is an event or situation that could have resulted in an accident, injury or illness, but did not, either by chance or through timely intervention. An example of a Near Miss would be: surgical or other procedure almost performed on the wrong patient due to lapses in verification of patient identification but caught at the last minute by chance. Near misses will receive the same level of analysis as Adverse Events that result in actual injury, and for learning purposes. 8. Malpractice: Improper or unethical conduct or unreasonable lack of skill by a holder of a professional or official position, often applied to physicians, dentists, nursing to denote negligent or unskillful performance of duties when professional skills are obligatory. Malpractice is a cause of action for which damage are allowed. 9. Variation: the differences in results obtained in measuring the same event more than once. The sources of variations can be grouped into two major classes: common causes and special causes. Too much variation often leads to waste and loss, such as the occurrence of undesirable patient health outcomes and increased cost of health services. RESPONSIBILITY 1. It is the responsibility of the person in charge to ensure that all OVR involving patient, personnel, or visitor injury, occupational illness to assure the stability of any injury in the first priority and have the OVR completed. 2. Resolution of problems identified thorough OVR system should always take place when possible within and between department(s) by responsible supervisory and management personnel including consultation with involved employee. 3. The Employee who witness or discover an occurrence has the professional obligations and responsibility for: a. Immediately notifying: i. The physician on call if the occurrence involves any question of patient or employee injury or harm. ii. The area supervisor. b. Initiating the OVR form before the end of the occurrence shift. c. Submitting the original of the OVR form to the supervisor on duty for completion. 4. The Supervisor is responsible for: a. Ensuring that all employees are aware of OVR system and how to report and process of OVR Standards Page 2 of 5
3 form. b. Conducting immediate follow-up of the occurrence by initiating and documenting on the OVR the actions taken at the time of the occurrence and any corrective measures taken to prevent a recurrences of the events. c. Ensuring thorough and accurate completion of the OVR form. d. Forwarding the completed OVR form to concerned person and CC to the office within 72 hours of the occurrence. e. Conducting any further investigation and documenting investigative findings of the reported occurrence upon request of the hospital administration, the QM committee or the safety committee. 5. The Physician: she/he is responsible to document a brief statement of his/her action(s) on the OVR form immediately upon completion the patient / employee examination and or the required care. 6. QM Department is responsible for: a. Monitoring all OVR(s) for follow up to the proper authorities so that necessary steps may be taken by those in-charge to resolve the situation if necessary. b. Trending and preparing a monthly summary of all reported occurrences. c. Submitting a quarterly report to the TQM committee for discussion and further action if deemed necessary by QM committee. d. Maintaining a file of all OVR submitted to the TQM office for 3 years. 7. The Safety Officer is responsible for: a. Investigating all safety related occurrences for investigation initiated by the TQM department b. Activating a Review Team of selected committee members to investigate critical safety related occurrences. c. Documenting the results of investigation and corrective action taken on the OVR form. d. Returning the completed form to the TQM office. e. Reviewing monthly summary data to determine if safety hazard issue exists and report to safety committee. 8. Annual Evaluation An annual evaluation of the OVR system shall be conducted and reported to the QM committee as part of the annual evaluation of the QM plan by the QM director. CROSS REFERENCES POLICY 1. It is the responsibility of all employees to immediately report the details of any occurrence that may negatively impacts the care of a patient. 2. The OVR form will be initiated immediately following any unusual or dangerous occurrence. 3. All sections of the OVR form must be completed and submitted to the immediate supervisor within the current work shift. 4. This report is to be used to identify the facts surrounding the occurrence and will not be used to criticize or speculate on actions of the staff involved 5. Corrective actions shall be taken to minimize risk of injury and adverse outcomes. Corrective action(s) shall be documented. Standards Page 3 of 5
4 6. The OVR form shall not be photocopied or placed in the medical record. The terms incident and error shall not be used in the medical record when making an entry regarding an occurrence or the results of an occurrence. 7. It is the responsibility of patient Safety manager to supply the Safety Committee with a quarterly summary of patient incidents. 8. In case of Adverse Drug Reactions, follow the Adverse Drug Reactions Reporting Policy. 9. In case of Medication Errors, follow the Medication Errors Reporting Policy # 10. Confidentiality: a. All OVR shall be handled and maintained in a confidential manner, with access to such documentation restricted to authorized individuals. b. OVR shall not be duplicated, with exception of the TQM department, when deemed necessary. c. The information contained in the OVR form cannot and shall not be used against any individual as the sole basis for disciplinary action. d. Hospital staff is not at liberty to discuss the contents of an OVR or the events and circumstances relative to the occurrence either with patient, visitor or other members of the staff, unless clarifying facts under investigation with the proper authorities. e. Discussion of general issues on OVR for instructional or educational purposes with view to improving patient care is, however, strongly encouraged. f. Names of involved / concerned person should not be used. Use ID # PROCEDURE General instructions: (guidelines how to use the Form) a. Use of OVR template. b. If not possible use blue ink. Avoid pencils, in clear legible handwriting c. Write objective view and comments. Avoid personal opinions. d. The OVR form consists of the following sections i. Upper right corner: Patient Information ii. Occurrence Details: (by the person witnessed / affected by the occurrence) iii. Person(s) affected iv. Affected employee information v. Occurrence brief description vi. Immediate action taken vii. Witness(es) Information viii. Supervisor Notification (included decision of sentinel event) ix. Physician Follow Up Notification x. Severity of Injury: 1. Slight / minor treatment: the incident resulted in abrasion, reddening of the skin, a bruise or other apparently minor damage to tissue. The treatment required was non-invasive for e.g. topical ointment, dressing or ice packs. Medication incidents that may require monitoring such as changes in vital signs or lab tests. 2. Moderate injury: the incident resulted in hemorrhage, tissue impairment and required clinical intervention. For e.g. suturing, first and second degree burns. Medication incidents with potential for serious outcomes that require intervention and monitoring. 3. Serious injury: the incident resulted in fracture, hemorrhage, aspiration, third degree burns, Standards Page 4 of 5
5 serious drug reaction or the incident resulted in admission to hospital (if outpatient), transfer to critical care area, or increase in length of stay (inpatient). 4. Death xi. Integrated Occurrence Strategy (as needed) Follow up, by responsible person/department, to include recommendations xii. TQM office comments xiii. Type of occurrences xiv. Contributing factors FORMS OVR Form EQUIPMENT REFERENCES APPROVAL: Prepared by Reviewed by Approved By Approved By Latest Revision Approved By Name Signature Date Standards Page 5 of 5
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HOSPITAL NAME INSTITUTIONAL POLICY AND PROCEDURE (IPP) Department: Manual: Section: TITLE/DESCRIPTION POLICY NUMBER SENTINEL EVENTS AND ROOT CAUSE ANALYSIS EFFECTIVE DATE REVIEW DUE REPLACES NUMBER NO.
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