Incident Reporting & Customer Complaint Management

1. Incident Reporting &Customer Complaint Management 2009 Yvonne Ciaravino Barbara Ann Karmanos Cancer Center April, 2009

2. What is an “Incident” • A situation or event that is out of the ordinary for routine patient care or the hospitals normal functioning. • A situation or event that could harm or potentially harm the health, life, comfort or property of: • a patient (Patient Incident) • an employee (Employee Incident) • a visitor (Visitor Incident)

3. What is an “Incident” • Examples of incidents include: • Adverse Drug Event: • Adverse Drug Reaction: Unexpected, unintended, undesired or excessive response to a medication • Medication Variance: a preventable event that may cause or lead to inappropriate medication use or patient harm • Property Incident: • Lost or damaged property belonging to visitors or KCC employees • These type of incidents are reported directly to Security

4. Patient Incidents (Patient Safety Events) • Situations or events that impact or nearly impact the patient include: • Medication events • Injury, falls, hospital acquired pressure ulcers • Missed, delayed or wrong treatment / procedure • Incidents involving a medical device: Where the device caused or almost caused patient harm: • Remove the device from service, leave the device plugged in to retain the ability to retrieve an electronic history, tag it and report incident immediately; • Include identifying features of the device (serial number, model number, name of equipment etc...) in the incident report • Breech of patient confidentiality (HIPPA violations) • Lost or damaged patient belongings

5. Documenting a Patient Incident • It is necessary to document patient incidents in the medical record. • Place an objective note in the patient’s chart documenting the facts of the event, physician findings and treatment. • DO NOT document that an incident report has been filed or refer to the incident number.

6. Employee Incidents (Employee Safety Events) • A situation or event occurring to an employee at Karmanos Cancer Center or its premises, that is not consistent with the employee’s routine work and may adversely affect or threaten to affect, the health, life, comfort or property of an employee. • Occurrences to be reported include: • Slip, trips and falls • Needle / sharps injuries • Blood or body fluids to exposures • Other incidents that result in potential Workers’ Disability claims or which require a Michigan Occupational Safety & Health Administration (MIOSHA) filing • Incidents of workplace conflict and /or verbal, physical, emotional abuse or harassment

7. Employee Incidents • Employee incidents must be reported to the department manager and entered into the incident reporting system. Incident entry can be done by the employee, manager or witness to the incident. • The Employee Injury/Illness Report must also completed per MIOSHA regulations. • The employee must report to the Emergency Department (ED) or Occupational Health Services (OHS). • The employee must take the Employee Injury/Illness Report with them when they report for evaluation or treatment to the ED or OHS. • Human Resources must be informed of all employee injuries.

8. Reporting Incidents • Employee Responsibility: • Report the incident as soon as it happens or as soon as you find out about it—after ensuring safety of the patient, employee or visitor • Report the incident to your supervisor or department manager • Enter the incident into the web based incident reporting system • Immediately report work-related accidents, injuries, or near miss events to your supervisor or department manager

9. Incident ReportingandFollow-up • Management Responsibility: • If the “downtime” paper form was used to report an incident, enter information into the web based incident reporting system and destroy the paper form after entry is complete. • Investigate the incident: • Interview staff and determine additional factual information • Update the documentation in the incident • Add corrective actions • Adjust level of impact as appropriate • Communicate incidents to other departments involved as indicated. • Ensure that all events are reviewed and have follow-up documentation within 14 days of event entry. • Close all events within 30 days of event entry with the exception of medication events and events with severity level of “F” or higher.

10. Incident ReportingandFollow-up • Management Responsibility: • Notify the Department Director, Administrator, Quality Department and Risk Management regarding any situation which may have the potential for significant negative outcomes, serious patient injury or adverse media attention. • Notify the Safety Officer regarding unsafe or hazardous conditions. • Report any employee lost time to Human Resources within 24 hours of incident. • Identify, implement, educate and document actions taken to lessen likelihood of incident recurring. • Encourage incident identification and entry by staff.

11. Incident Reporting andFollow-up • Other Department Responsibilities: • Pharmacy: • Pharmacy reviews and closes all medication related events. • If a drug is reported to the FDA Medical Products Reporting Program (MEDWATCH), pharmacy will document this in the “follow up” section of the incident report. • Quality & Regulatory Affairs: • Reviews all incidents. • Closes all events (excluding medication events) with severity level of “F” or higher.

12. Complaint Reporting • Patient, Family and Visitor Complaints: • Karmanos Cancer Center encourages patients, families and visitors to freely express their grievances, complaints, concerns, dissatisfactions and inquiries through established channels without being subject to coercion, discrimination, reprisal, or unreasonable interruption of care, treatment and services. • We welcome feedback from our patients, families and visitors and are attentive to all concerns shared. • Feedback provides us with the opportunity to learn about our customer’s experience and make improvements if necessary to exceed their expectations.

13. Complaint Reporting • Patient, Family and Visitor Complaints—definitions: • Medical Grievance: Any complaint (written or verbal) the subject of which is the quality of care received, or premature discharge, or release of patient, including complaints against physicians. • Concern / Dissatisfaction: Any expression of concern or dissatisfaction (written or verbal) with a service or facility provided by the Karmanos Cancer Center, that is resolved to the satisfaction of the complainant, at the point of complaint or at the point of service.

14. Complaint Reporting • Patient, Family and Visitor Complaints—definitions: • Grievance: Any expression of dissatisfaction (complaint) related to an occurrence within a Karmanos Cancer Center facility, which is of such severity that it is not able to be resolved to the satisfaction of the complainant at point of service. Examples include: • Delays in service • Patient care • Facility policy or procedure • Cost / billing / insurance • Lack of respect / privacy • Safety of patient environment • Environmental concerns • Equipment

15. Complaint Reporting • Patient, Family and Visitor Complaints—timeliness: • Whenever possible, employees will address and attempt to resolve issues immediately, at the point of service. • If the complaints cannot be resolved at point of service to the satisfaction of the patient, family or visitor, it will be entered into the Incident and Complaint Management System. • The complaint will then be managed as a formal grievance by the Customer Service Department. • Management and the Customer Service Department will attempt to contact the patient/family within 2 business days. • All formal grievances are brought to closure within 30 days of receipt. • A summary of our investigational findings is provided to the complainant in a formal letter format within the 30 day period.

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