Cerner Quality System (CQS)

Cerner Quality System (CQS)

Contingent Workforce: Cerners Internal Complaint Handling System - CHIA Contingent Workforce: Cerners Internal Complaint Handling System - CHIA Version: 1 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information belonging to Cerner Corporation and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of Cerner. Overview (continued) Some of Cerners solutions are considered medical devices. Therefore, Cerner must meet the Quality System Regulations (QSR 820.100 & QSR 820.198) of the FDA, which requires Cerner to have a complaint handling system. Cerner must document how the investigation was performed and the response to those issues. Cerners system is called the CHIA system. Cerners global locations also have Competent Authorities that require formal processes to address client concerns. Complaints are defined as any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, safety, effectiveness, or performance of a device after it is released for distribution.

All associates, including contingent workers, are responsible for knowing about the existence of Cerner's CHIA system. In addition, all associates have a responsibility to record any event and all subsequent activities related to an event that qualifies for CHIA reporting. CHIAs can be identified internally (i.e. during testing, etc.) or from external data inputs (client feedback, Post-market surveillance, etc.) 2011 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. 2 Overview (continued) Once a possible CHIA is identified, there is a specific process for communication to clients, documentation of the event, investigation of the event, corrective action/preventive action documentation, and review for closure. There are stringent timelines that must be adhered to so time is of the essence when identifying an issue requiring a CHIA. For complete details regarding the CHIA process, ask your monitor for a copy of 01WI000001 CHIA Work Instructions. The CHIA process is Cerners internal means of escalating and resolving critical issues that

may relate to a number of situations, including, but not limited to patient safety. Do not share CHIA information with Cerner clients; this information is considered confidential Any mention of CHIAs in SRs should be marked as internal. Identifying and escalating suspected CHIA issues to your monitor immediately is critical so that Cerner can meet our required timelines: CHIA records be opened within 7 days from the date Cerner was made aware of the issue Due to escalation processes for patient care events, high risk CHIAs (i.e. those resulting in MDRs/Vigilance Reports) must be reported to appropriate regulatory agencies within 30 days. Cerner is responsible for notifying all affected clients of issues that have broad impact. The turn-around time for applicable client notifications (e.g., Flash) associated with CHIAs is 30 days from the date the issue was identified. 2011 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. 3 CHIAs for example Security breaches Unauthorized access to data

Improper access to client environment or mishandling of Protected Health Information (PHI) by a Cerner Associate May impact compliance with security and privacy regulations such as HIPAA, Safe Harbor, etc. Hardware/software failures Unscheduled down time Warning messages not displayed or incorrect Functions not working as intended Software issues (dates showing incorrectly, truncation, etc.) Incorrect or incomplete patient information in inquiries or on charts Incorrect software calculation causing incorrect results Service Client complaints related to significant installation, service issues and contract disputes User error Cerner responsible Client alleges breach of contract by Cerner Financial /Regulatory Incorrect/incomplete capture of patient billing information (May cause issues with billing regulations)

Unscheduled down time Labeling Incomplete or incorrect user documentation 2011 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. 4 Client Request/Complaint Escalation There are three levels of client request/complaint escalation: MDRs/Vigilance Reports CHIAs Service Requests, emails, and letters MDRs/Vigilance Reports Vigilance Reports are a small sub-set of elevated complaints that are reported by Cerner to the FDA or other global regulatory agencies after the severity and recurrence factors of a CHIA are evaluated and determined to have a high level of risk to patient safety. CHIAs These are complaints that are identified as an event that has resulted or may result in significant financial, patient/donor care, privacy or security, or regulatory

impact. Service Requests, Emails, Letters Not all complaints are escalated; for example, simple database changes that do not affect patient care are considered a Service Request and do not require escalation. 2011 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. 5 Determining if an issue requires a CHIA Severe issues must be reported to Cerners Regulatory Affairs group (RA/QA) immediately. Escalate severe issues to your monitor as soon as they are discovered so that your monitor can notify RA/QA. If you need assistance determining if an issue requires a CHIA, contact you monitor, and they will engage the appropriate Compliance Analyst or RA/QA if additional help is needed. If a CHIA is necessary, notify your monitor so they can

ensure that the appropriate Quality Representative or Compliance Analyst opens the record within the required 7 days. For additional information regarding the CHIA process, contact your monitor. RA/QA also can provide additional information and assistance. Email questions to [email protected] mailbox 2011 Cerner Corporation. All rights reserved. This document contains Cerner confidential and/or proprietary information which may not be reproduced or transmitted without the express written consent of Cerner. 6 For For questions, questions, contact contact [email protected] [email protected]

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