GENERAL ADMINISTRATIVE POLICY: ADVERSE EVENT REPORTING TO CALIFORNIA DEPARTMENT OF PUBLIC HEALTH (CDPH) Effective Date: 02/12 Page No. 1 of 7 I. PURPOSE To comply with mandated reporting requirements of the California Health and Safety Code 1279.1(b) which supports the improvement of patient safety and quality and performance improvement initiatives. II. POLICY It is the policy of The University of California Irvine Medical Center (Medical Center) to report an adverse event, as defined within the California Health and Safety Code 1279.1(b) to the California Department of Public Health(CDPH) no later than 5 days after the event has been detected; or, if the event is an ongoing, urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, no later than twenty-four (24) hours after the adverse event has been detected. It is also the policy of The University of California Irvine Medical Center to fully investigate the event, initiate any mitigation actions that may be indicated and to fully cooperate with CDPH throughout the process. III. DEFINITIONS Serious : 1. Physical or mental impairment that substantially limits one or more of the major life activities of an individual, if the impairment lasts more than 7 days or is still present at the time of discharge, or 2. The loss of bodily function, if the loss lasts more than 7 days or is still present at the time of discharge, or 3. The loss of a body part Reportable Adverse Event: Includes adverse events resulting from the unauthorized disclosure of Protected Health Information (SB541) or the below listed events (SB1301). SURGICAL EVENTS 1. Surgery performed on a wrong body part that is inconsistent with the documented informed consent of the patient (note: a reportable event does not include a situation requiring a prompt action that occurs in the course of surgery or a situation that is so emergent as to 1
Page 2 of 7 preclude obtaining informed consent) 2. Surgery performed on the wrong patient 3. The wrong surgical procedure performed on a patient that is inconsistent with the documented informed consent of the patient (note: a reportable event does not include a situation requiring a prompt action that occurs in the course of surgery or a situation that is so emergent as to preclude obtaining informed consent) 4. Unintentional retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as a part of a planned intervention and objects present prior to the surgery that are intentionally retained 5. Death during or up to 24 hours after induction of anesthesia after surgery of a normal, healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance and from whom the pathologic processes for which the operation is to be performed are localized and do not entail a systemic disturbance. PRODUCT OR DEVICE EVENTS 1. Patient death or serious disability associated with the use of a contaminated drug, device, or biologic provided by the medical center when the contamination is the result of generally detectable contaminants in the drug, device, or biologic, regardless of the source of the contamination or the product. 2. Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended. Device may include but is not limited to a catheter, drain, or other specialized tube, infusion pump, or ventilator. 3. Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in the medical center, excluding deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism. PATIENT PROTECTION EVENTS 1. An infant discharged to the wrong person 2. Patient death or serious disability associated with a patient s disappearance for more than four (4) hours (excludes events involving adults who have competency or decision-making capacity. 3. Patient suicide or attempted suicide resulting in serious disability due to patient actions after admission to the medical center (excludes deaths from self-inflicted injuries that resulted in admission to the medical center) CARE MANAGEMENT EVENTS 1. Patient death or serious disability associated with a medication error, including but not limited to: an error involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration (excludes reasonable differences in clinical judgment on drug selection and dose) 2. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products. 3. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy, including events that occur within 42 days post-delivery (excludes deaths from 2
Page 3 of 7 pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy) 4. Patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for by the medical center 5. Patient death or serious disability, including kernicterus, associated with failure to identify and treat hyperbilirubinemia in neonates during the first 28 days of life (hyperbilirubinemia is defined as bilirubin levels greater than 30 milligrams per deciliter) 6. A Stage 3 or Stage 4 ulcer acquired after admission (excludes progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission) 7. Patient death or serious disability due to spinal manipulative therapy performed at the medical center ENVIRONMENTAL EVENTS 1. Patient death or serious disability associated with an electric shock while being cared for in the medical center (excludes events involving planned treatment such as electric countershock) 2. Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by a toxic substance 3. Patient death or serious disability associated with a burn incurred from any source while being cared for by the medical center 4. Patient death associated with a fall 5. Patient death or serious disability associated with the use of restraints or bedrails CRIMINAL EVENTS 1. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider 2. Abduction of a patient of any age 3. The sexual assault on a patient within or on the grounds of the medical center 4. Death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the ground of the medical center 5. An adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor IV. DISCLOSURE OF ADVERSE EVENTS After consultation with Risk Management and/or Senior Hospital Management, the patient, or the legal representative of the patient, will be notified by the primary attending physician or his/her designee, of the nature of the adverse event by the time the report to CDPH is made. Such disclosure will be documented in the patient s medical record. The patient, or the patient s legal representative, shall not be provided a copy of the report made to CDPH. The report made to CDPH will not be placed in the patient s medical record, but will be retained by the Office of Risk Management. V. ADJUSTMENT OF HOSPITAL CHARGES After consultation with the Chief Medical Officer, the Director, Risk Management may make adjustments to hospital and professional fee charges related to the adverse event if the event has been 3
Page 4 of 7 determined to have been preventable. VI. PROCEDURES RESPONSIBLE PERSON(S)/DEPT. Faculty, Staff PROCEDURE A. INTERNAL NOTIFICATION OF ADVERSE EVENT Upon identification of an adverse event as defined above, the faculty or staff member responsible for detecting the event shall do the following: 1. Complete an online incident report (see Attachment I: Category Mapping). The report should include sufficient information to identify the nature and other pertinent or material facts of the event. The online incident report will electronically send an email notification to the Chief Medical Officer, Chief Nursing Officer, Legal Counsel and Risk Management. 2. After submission of the online incident report, the reporter will contact the Office of Risk Management at ext. 5676 to file a verbal report. B. REPORTING TO DEPARTMENT OF HEALTH SERVICES (CDPH) Risk Management 1. Any adverse event deemed as potentially reportable to CDPH will be clinically validated. 2. It will be the responsibility of the Director, Risk Management to develop and submit the initial report to CDPH, as well as serve as the liaison with CDPH during the subsequent investigation process. Disclosure of individually identifiable patient information is permitted and shall be consistent with applicable law. 3. In the event of absence of the Director of Risk Management, the initial report will be prepared by the Office of Risk Management, under the direction of the Chief Medical Officer and/or the Chief Nursing Officer. 4. The initial report will be submitted in accordance with the requirements set forth by CDPH (no later than 5 days after the event has been detected; or, if the event is an ongoing, urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, no later than twenty-four (24) hours after the adverse event has been detected) C. INVESTIGATION Risk Management 1. An investigation into the cause of the adverse event may be undertaken pursuant to the Medical Center s Intensive Review Process policy. The investigation would be conducted for the purpose of the evaluation and improvement of the quality of care in the medical center. It shall be the responsibility of Risk Management to coordinate the initial investigation and support the Root Cause Analysis investigative process within the framework of the Performance Improvement Committee. 2. Any errors or issues associated with either personnel or systems performance discovered during the course of the investigation and Intensive Review process shall be addressed through a Plan of 4
Page 5 of 7 Chief Executive Officer Director, Risk Management Correction ( Action Item Report ) submitted to the Patient Safety Steering Committee. 3. Preparation of the CDPH Corrective Action Plan shall be the responsibility of the Director, Risk Management. Such response will be prepared and submitted to the CDPH within the legal time frame. 3. The Action Item Report will remain open until such time as all recommended actions have been completed and/or addressed. D. APPEAL OF PENALTY 1. If a penalty is imposed by the Department of Health Services, the decision to contest such penalty will be made by the Chief Executive Officer after consultation with the Chief Medical Officer, Chief Nursing Officer, Risk Management, and Legal Counsel. 2. In the event the decision is made to contest a penalty, the Director of Risk Management will request an adjudicative hearing pursuant to Health and Safety Code 100171 and the provisions of the Government Code 11400 and 11500 et seq. Payment of penalties will be made only if (1) the findings have not been reversed in whole or in part, and (2) the appeal process has been exhausted. IV. REFERENCES California Health & Safety Code Senate Bill 1301 Senate Bill 541 Policy: Intensive Review Process Date Written: 05/07 Date Reviewed/Revised: 11/08, 02/12 Author: Approvals: Nance Hove, CPHRM, LHRM Risk Management Reviewed w/no changes February 27, 2012 Policy Review Committee November 11, 2008 Performance Improvement Committee November 12, 2008 Med Exec Committee November 17, 2008 Governing Body November 24, 2008 5
Page 6 of 7 INCIDENT REPORTING SYSTEM MAPPING TO REPORTABLE EVENTS REPORTABLE EVENT TO DHS INCIDENT REPORT CATEGORY INCIDENT REPORT SUBCATEGORY SURGICAL EVENTS Surgery Performed on Wrong Body Part Surgical Issues Wrong Site/Side/ Patient/Procedure Surgery Performed On Wrong Patient Surgical Issues Wrong Site/Side/ Patient/Procedure Wrong Surgical Procedure Surgical Issues Wrong Site/Side/ Patient/Procedure Unintentional Retention of Foreign Object Surgical Issues Unintentional Retention of Foreign Object Death During Or Up to 24 Hrs After Induction of Anesthesia PRODUCT OR DEVICE EVENTS Pt death/serious disability associated with use of contaminated drug, device, biologic Surgical Issues Anesthesia Issues Medical Devices/Products Death in OR Death Within 24 Hours Death/Serious Pt death/serious disability associated with use or Medical Devices/Products Death/Serious function of device Pt death/serious disability associated with intravascular air embolism Diagnosis/Treatment Issues PATIENT PROTECTION EVENTS Infant discharged to wrong person Patient Protection Infant discharge to wrong person Patient death/serious disability associated with patient s disappearance Patient suicide/attempted suicide resulting in serious disability CARE MANAGEMENT EVENTS Pt death/serious disability associated with medication error Pt death/serious disability associated with hemolytic reaction Maternal death/serious disability associated with labor or delivery in a low risk pregnancy Pt death/serious disability directly related to hypoglycemia Pt death/serious disability, incl. kernicterus, associated With failure to identify/treat hyperbilirubinemia in neonates Neuropsych Behavior Patient Protection Medication Related Event Transfusion Issues (Blood Bank Staff) Diagnosis/Treatment Issues Diagnosis/Treatment Issues Diagnosis/Treatment Issues Patient Disappearance Patient Suicide/Attempted suicide Death/Serious Maternal Death Stage 3 or 4 ulcer acquired after admission Skin Issues Pressure Ulcers: Stage 3/4 Pt death/serious disability due to spinal manipulative therapy Diagnosis/Treatment Issues ENVIRONMENTAL EVENTS Pt death/serious disability assoc. w/electric shock Environmental Safety Death/Serious 6
Page 7 of 7 Any incident in which a line designated for oxygen or Environmental Safety Wrong Gas/Contamination other gas contains wrong gas or is contaminated by a toxic substance Pt death/serious disability associated with a burn Environmental Safety Death/Serious incurred from any source while hospitalized Pt death associated with a fall Fall/Injury Other than Fall Death/Serious (Patient) Pt death/serious disability associated with use of Fall/Injury Other than Fall Death/Serious restraints or bedrails (Patient) CRIMINAL EVENTS Any instance of care ordered or provided by someone Other Criminal Event impersonating a physician, nurse, pharmacist or other licensed healthcare provider Abduction of a patient of any age Patient Protection Abduction Sexual assault on a patient Patient Protection Patient Assault Death/significant injury of patient or staff member resulting from a physical assault Patient Protection Workplace Violence Patient Assault Staff Death/Significant Adverse event, or series of events, that cause the death/serious disability of a patient, visitor, or personnel Injury Note: covered under multiple other categories 7