Clinical Interdepartmental Policy and Procedure

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Clinical Interdepartmental Policy and Procedure Policy: Staff Response to Medical Errors/Adverse Events Policy Number: MR-006 Joseph S. Gordy, CEO Signature: Flagler Hospital Originator: President Coordinating Departments: All Departments Original Issue Date: May 13, 2002 Current Revision Date: 5/14/04 10/27/05 6/9/06 1/8/15 Last Review Date: Chapter: Regulatory References: Other References: Medical Error Reporting 2655Page 1 of 5 Flagler Hospital 400 Health Park Blvd. St. Augustine, Fl. 32086

POLICY: STAFF RESPONSE TO MEDICAL ERRORS/ ADVERSE EVENTS OBJECTIVE: It is a policy of this hospital to establish a procedure for the immediate response to medical/health care errors, including care of the affected patient, containment of risk to others, and preservation of factual information for subsequent analysis. RESPONSE TO ERROR Upon identification of a medical/health care error, the patient care provider will immediately: 1. Perform necessary healthcare interventions to protect and support the patient's clinical condition. 2. As appropriate to the occurrence, perform necessary healthcare interventions to contain the risk to others - example: immediate removal of contaminated IV fluids from floor stock should it be discovered a contaminated lot of fluid solutions was delivered and stocked. Also, immediately remove from service any malfunctioning equipment that was involved in a medical error refer to the P&P on Defective Equipment. P&P - DEFECTIVE EQUIPMENT JAN 2015 EOC-007 3. Contact the patient's attending physician and other physicians, as appropriate, to report the error, carrying out any physician orders as necessary. 4. Preserve any information related to the error (including physical information). Examples of preservation of physical information are: Removal and preservation of blood unit for a suspected transfusion reaction; preservation of IV tubing, fluids bags and/or pumps for a patient with a severe drug reaction from IV medication; preservation of medication label for medications administered to the incorrect patient. Preservation of information includes documenting the facts regarding the error on an incident report, and in the medical record as appropriate to organizational policy and procedure. 5. Report the medical/health care error to the staff member's immediate supervisor. 6. Submit the incident report to the Risk Manager per organizational policy. 7. The physician or his designee shall be responsible for informing the patient of the error, the potential or actual impact of the error on his or her physical and/or psychological condition, and the subsequent care that will be provided. (See policy on Disclosure of Medical Errors). P&P - DISCLOSURE OF MEDICAL ERRORS JAN 2015 MR-001 8. Any individual in any department identifying a potential patient safety issue will immediately notify his or her supervisor and submit an incident report within 72 hours via RL Solutions to the Risk Manager. 2655 Page 2 of 5

9. Staff response to medical/health care errors is dependent upon the severity of the error identified: SEVERITY LEVELS: v Near Miss Errors: o Definition: Circumstances or events that have the capacity to cause error or an error occurred but the error did not reach the patient. o Reporting Tool: Staff should make every effort to report near miss errors in RL Solutions. If a more anonymous approach is necessary, then the error can be reported via the red box anonymous reporting system, or the F.H. Intranet giving the circumstances of the event. o Notification: The staff member may have the option of reporting this error to a supervisor; however, in the interest of patient safety, near misses should be quickly identified and addressed to prevent an actual error from occurring. v No Harm Errors: o Definition: These are errors that reached the patient but did not cause patient harm and may or may not have resulted in the need for increased patient monitoring. o Reporting Tool: A No Harm Error should be reported via incident report (within 72 hours of the event) in RL Solutions. These types of errors could include a medication error or patient fall where no injury to the patient was sustained. v Mild Adverse Outcome Errors: o Definition: Error that resulted in the need for treatment or intervention and caused temporary patient harm. o Reporting Tool: A Mild Adverse Outcome Error should be reported via incident v Moderate Adverse Outcome Errors: o Definition: An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm. o Reporting Tool: A Moderate Adverse Outcome Error should be reported via incident 2655 Page 3 of 5

v Severe Adverse Outcome Errors: o Definition: An error that resulted in permanent patient harm, a near death event (anaphylaxis, cardiac arrest), or patient death. o Reporting Tool: A Severe Adverse Outcome Error should be reported via incident The staff member should also immediately notify the Risk Manager (within 24 hours) or the administrator on call. RESPONSE TO ADVERSE EVENTS 1. The following are categories of incidents that should be reported to Leadership through the following reporting mechanisms: TYPES OF INCIDENTS v Adverse Clinical Event: o Definition: an injury related to medical care may or may not be due to error. o Reporting Tool: Incident Report - Staff shall report these events via an incident report (RL Solutions) submitting the report to the Risk Manager per organizational policy. v Medication Error: o Definition: Inappropriate processes in drug therapy that may cause adverse drug events. These processes include errors in prescribing, distribution, and administration. o Reporting Tool: Incident Report submitted within 72 hrs via RL Solutions. v Patient Falls: o Definition: A fall is a loss of upright position that results in landing on the floor, ground or object of furniture or sudden uncontrolled, unintentional, non-purposeful, downward displacement of the body to the floor, stairs, etc. It includes an unwitnessed fall, a near fall, or an assisted fall. o Reporting Tool: Incident Report submitted within 72 hrs via RL Solutions. v Adverse Drug Reaction: o Definition: An untoward drug effect that occurs during normal and correct medical care, not related to an error. o Reporting Tool: Incident Report submitted within 72 hrs via RL Solutions or E-mail to pharmacy director the chart #, date of reaction, drug name and reaction noted; or, call the Pharmacy, or notify via the FH Intranet. v Transfusion Reaction: o Definition: An untoward blood transfusion effect that occurs during normal and correct medical care, not related to an error. o Reporting Tool: Transfusion Reaction Form. If reaction was due to an ERROR, then must ALSO complete an incident report and submit to the Risk Manager per organizational policy. o Notification: Notify the attending physician. 2655 Page 4 of 5

v Hazardous Condition/Patient Safety Issue o Definition: any set of circumstances, exclusive of the disease or condition for which the patient is being treated, which significantly increases the likelihood of a serious physical or psychological adverse patient outcome. o Reporting Tool: Complete an Incident Report submitting the report to the Risk Manager per organizational policy. o Notification: The staff member shall notify his/her immediate supervisor. Consider notifying the Safety Director. o Containment: as appropriate, and if possible, staff will contain the hazardous condition or patient safety issue. 2655 Page 5 of 5