02-04.07 ADVERSE EVENT REPORTING AND REVIEW PROCEDURE I. OVERVIEW A. PURPOSE: To detail the process for reviewing and reporting Adverse Events. II. DEFINITIONS A. Adverse Event: An untoward, undesirable, and usually unanticipated event such as sentinel event, critical event, or risk event. B. Sentinel Event is defined as follows: 1. An unexpected occurrence involving death (not due to the natural cause or a health condition) or risk thereof. a. The phrase: or risk thereof includes any process variation for which reoccurrence would carry a significant chance of a serious adverse outcome. 2. Serious physical or psychological injury or risk thereof. Serious injury specifically includes loss of limb or function (Commission on Accreditation for Residential Facilities (CARF) sentinel event definition, 2017 Behavioral Health Standards Manual pg. 368). 3. Is an unexpected occurrence involving death or serious physical or psychological injury or risk thereof. 4. Serious injury specifically includes permanent loss of limb or function. 5. Injury or death that occur from the use of any behavior intervention (MDHHS Contract 2017). C. Critical Event Events that have resulted in harm to individuals who are actively receiving services. Critical events include the following events: 1. Suicide a. Defined: CMHSP (Community Mental Health Service Provider) or Coroner s Report determines death was a suicide. A best judgment can be made by the CMHSP if death report is not available. b. Who: Was a recipient at the time of death, was actively receiving services or received emergency services within last 30 calendar days. 2. Non-Suicide Death a. Defined: Any recipient death not otherwise reported as suicide. b. Who: Recipient was actively receiving services AND either living in specialized residential or CCI (Child Caring Institution) or receiving CLS (Community Living Supports), Supports Coordination, Targeted Case Management, ACT (Assertive Community Treatment), Home based, Wrap Around, HSW (Habilitation Supports Waiver) services, SED (Serious Emotional Disturbance) Waiver Services, or Children s Waiver services. Page 1 of 9
3. Emergency Medical Treatment (EMT) due to injury or medication error a. Defined: Injury to recipient, or medication error, that results in face-to-face treatment. Any treatment facility, such as physician, urgent care, Emergency Room (ER), etc. b. Who: Recipient, at the time of event, was actively receiving services AND Either living in specialized residential, children s crisis residential/cci or Receiving HSW services, SED Waiver services, or Children s Waiver services. 4. Hospitalization due to injury or medication error a. Defined: Inpatient admission as a result of Injury or Medication Error. b. Who: Recipient, at the time of event, was actively receiving services AND Either living in specialized residential, children s crisis residential/cci or Receiving HSW services, SED Waiver services, or Children s Waiver services. 5. Arrest of an individual a. Defined: Situations where individual is held or taken by law enforcement officer based on the belief that a crime may have been committed. Transport for emergency services or protective custody are not considered arrest. b. Who: Recipient, at the time of event, was actively receiving services AND Either living in specialized residential, children s crisis residential/cci or Receiving HSW services, SED Waiver services, or Children s Waiver services. 6. Physical management and/or involvement of law enforcement, permitted for intervention in emergencies only, are considered critical incidents that must be managed and reported according to the Quality Improvement and Performance Improvement Program (QAPIP) standards. D. Actively Receiving Services: for the sake of Critical Incident Reporting, an individual is considered to be actively receiving services when any of the following occur: 1. A face-to-face intake has occurred and the individual was deemed eligible for ongoing service, or 2. The CMHSP/Prepaid Inpatient Health Plan (PIHP) has authorized the individual for ongoing service, either through a face to face assessment or a telephone screening, or 3. The individual has received non-crisis, no-screening encounter. The period during which the individual is considered to be actively receiving services shall take place between the following begin date and end date, inclusively: a. Begin Date: Actively receiving services begins when the decision is made to start providing on-going non-emergent services. Specifically, the beginning date shall be the first date that any of the 3 conditions referenced above occurs. b. End Date: When the individual is formally discharged from services. The date the discharge takes effect shall be the end date. This should also be the date that is Page 2 of 9
supplied to the individual when the individual is notified that services are terminated. E. Risk Events Adverse events that put individuals at risk of harm; these events minimally include the following: 1. Actions taken by individuals who cause harm to themselves 2. Actions taken by individuals who cause harm to others 3. Two or more unscheduled admissions to a medical hospital (not due to planned surgery or the natural course of a chronic illness, such as when an individual has a terminal illness) within a 12-month period. F. Near Misses A situation in which consequence was avoided however a review maybe required to promote a safer environment. III. PROCEDURE A. Adverse events are to be recorded in LifeWays Electronic Organizer (LEO LifeWays electronic medical records program) as follows: 1. Sentinel Event a. Once the Incident Report (IR) is received by the Office of Recipient Rights (ORR), the ORR shall categorize the IR by checking under Severity: Potential Sentinel Event and Immediately Reportable Event (please see below applicable screenshot from LEO). b. The ORR shall also identify the individuals notified on the IR in LEO under Persons Notified which for sentinel events includes at a minimum: i. Chief Executive Officer (CEO), Chief Operations Officer (COO), Chief Clinical and Quality Officer (CCQO), Medical Director, Risk Manager and they must be notified IMMEDIATELY. c. The ORR shall record the sentinel event in LEO under Sentinel Events by clicking Add Sentinel Event under All Sentinel Events. Because all sentinel events are critical events the ORR will need to identify which critical event the sentinel event is. NOTE: not all critical events are sentinel events refer to definitions in this procedure, but every sentinel event is a critical event. d. The ORR shall also document dates regarding Root Cause Analysis. 2. Critical Event a. Once the IR is received by the ORR, the ORR shall categorize the Incident Report by checking under Severity: Potential Critical Event Page 3 of 9
b. The ORR shall also identify the individuals notified on the IR in LEO under Persons Notified which for critical events include at a minimum: i. All Deaths the medical director and the Risk Manager ii. All Critical Events the Critical Event Review Team c. The ORR shall notify its Administrative Assistant or designee of each Critical Event. d. Within 1 business day, the ORR Administrative Assistant or designee shall report the Critical Event in LEO under MDCH Reporting MDCH Event Reporting by Individual - Add Critical Event (please see flow chart). e. Prior to monthly submission, ORR Supervisor shall review historical IR s to verify all CI s were reported. f. Monthly submission shall occur on the last Friday of the month by the ORR Supervisor (please see flow chart). 3. Risk Event a. Once the IR is received by the ORR, the ORR shall categorize the IR by checking under Severity: Potential Risk Issue b. The ORR shall also identify the individuals notified on the Incident Report in LEO under Persons Notified which for risk events include at a minimum: i. Risk Manager B. Adverse events are to be reported as follows: Event Type Reported Timeliness Method Responsible To Sentinel Event CARF Within 30 days of the event CARF Form Sentinel Event via email: asc@carf.org or fax (520) 495-7080 and Office of Recipient Rights LifeWays Quality Improvement must be cc d Sentinel Event MDHHS Immediately Via email communication to the MDHHS Risk Manager contract manager and LifeWays CEO must be cc d Sentinel Event MSHN Immediately Via email communication to the MSHN Risk Manager contract manager and LifeWays CEO must be cc d Critical Event: Suicide Non-Suicide EMT Hospitalization Arrest MSHN Within 30 days after the end of the month in which the event occurred. Via Electronic Medical Record MDCH Reporting Module Submit All Events Office of Recipient Rights Critical Event: Physical management or law enforcement involvement MSHN Within 30 days after the end of the quarter in which the event occurred. Spreadsheet sent via email to MSHN Todd.Lewicki@midstatehealthnetwork.org and katy.hammock@midstatehealthnetwork.org Quality Improvement Page 4 of 9
C. Events types are determined and categorized by the ORR according to definitions used in this procedure. D. Events are submitted to the ORR by IR. IRs are to be submitted through LEO and in the event the scanner is not working, by fax. E. All IRs received via faxed shall be uploaded to LEO. IV. ADVERSE EVENT REVIEW A. All sentinel events must be reviewed and acted upon as appropriate, with root cause analyses to commence within two business days of the sentinel event as requested by Critical Event Review Team (CERT) member. B. Staff involved in reviewing and analyzing sentinel events must have the appropriate credentials to review the scope of care. Sentinel events that involved death or serious medical conditions, must involve a physician or nurse. C. All unexpected deaths (suicide, homicide, an undiagnosed condition, were accidental, or were suspicious for possible abuse or neglect) of Children s Waiver and SED Waiver beneficiaries, who at the time of their deaths were receiving specialty supports must be reviewed and must include: 1. Screens of individual deaths with standard information (e.g. coroner s report, death certificate) 2. Involvement of medical personnel in the mortality reviews. 3. Documentation of the mortality review process, findings, and recommendations. 4. Use of mortality information to address quality of care. 5. Aggregation of mortality data over time to identify possible trends. D. All critical events are to be reviewed by the CERT committee, which is a quality improvement committee. ORR is responsible for preparing all events to be reviewed by CERT refer to the CERT Charter for details. E. All Risk Events shall be reviewed by the Risk Manager who shall take appropriate action to reduce risk to the agency and refer to CERT as needed for ongoing quality improvement efforts. 1. The Risk Manager shall reflect all activities performed to reduce risk in the Risk Management Plan and measure their effectiveness. ATTACHMENTS Process Flow Monthly Critical Event Submission Page 5 of 9
Process Flow Individual Critical Event Entry REFERENCES Audience: LifeWays Staff LifeWays Provider Network MSHN Critical Incidents Procedure MSHN Contract MDHHS Contract CARF Behavioral Health Standards Manual HISTORY Effective 05/29/1998 Reviewed/Revised: Rev. 9/12, 4/13, 4/14, 11/14, 2/15, 2/16, 2/17, 2/18 Page 6 of 9
Process Flow Individual Critical Event Entry 1. ORR Supervisor/Specialist receives individual IR. 2. After ORR Supervisor/Specialist codes IR, IR is noted as a Critical Event: a. Suicide b. Non-suicide Death c. Emergency Medical Treatment due to Injury or Medication Error d. Hospitalization due to Injury or Medication Error e. Arrest of Consumer 3. ORR Supervisor/Specialist sends daily notice, when applicable, of Critical Event(s) to ORR Administrative Assistant via email. 4. Once received, ORR Administrative Assistant selects Critical Event in MDCH Reporting tab in LEO. 5. ORR Administrative Assistant then selects MDCH Event Reporting by Consumer. 6. ORR then enters consumer information within 1 business day. 7. ORR then selects events. Page 7 of 9
8. Then selects Add Critical Event. 9. Once in Critical Event: a. Add Event Date. b. Select Event Type. c. Then select if event is reportable. d. Then select Save. Page 8 of 9
Process Flow Monthly Critical Event Submission 1. On the last Friday of each month, ORR Supervisor selects MDCH Reporting tab in LEO. 2. ORR Supervisor selects MDCH Event Reporting History. 3. ORR Supervisor selects here or submit all CRITICAL Events. to submit critical events on monthly basis. 4. In the event that ORR Supervisor gets an error, please enter a LEO Help Desk Ticket. 5. The EMR Administrator will have to reset the password for the account to submit Critical Events. Page 9 of 9