.Health MEMO RANDUM TO: Deborah A. McGrew Vice President & Chief Operations Officer, UTMB Health System FROM:

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MEMO RANDUM TO: FROM: DATE: Deborah A. McGrew Vice President & Chief Operations Officer, UTMB Health System Kimberly K. Hagara, CPA, CIA, CISA, C fl )..J-k>.t..._. Vice President,?Y '..r(f - February 23, 2017 SUBJ ECT: CMC-HG Patient Safety Reporting Process Engagement Number 2017-012 Attached is the final audit report regarding the Texas Department of Criminal Justice (TDCJ) Hospital Galveston (HG) and Correctional Managed Care (CMC) patient safety reporting processes. This audit will be presented at the next Institutional Audit Committee meeting. Additionally, please find attached audit recommendation follow up policy. Each of the recommendations is classified by type at the end of its identifying number: System Priority (SP), Risk Mitigation (R), or Process Improvement (P). As you will note in the policy, the classification of the recommendation determines the frequency of our follow up. All follow up results are reported quarterly to the Institutional Audit Committee. Thank you for your cooperation and assistance during the course of this review. If you have any questions or comments regarding the audit or the follow-up process, please feel free to contact me at (409) 747-3277. Attachment c: Donna K. Sollenberger Owen J. Murray, DO Olugbenga B. Ojo, MD

utmb Health The University of Texas Medical Branch Audit Report CMC-HG Patient Safety Reporting Process Engagement Number 2017-012 The University of Texas Medical Branch 301 University Boulevard, Suite 4.100 Galveston, Texas 77555-0150

Background The University of Texas Medical Branch's (UTMB Health's) Correctional Managed Care Program provides or oversees the medical, mental health, and dental services for more than 126,ooo offender patients located in more than 100 adult and juvenile correctional facilities throughout Texas. Patients receive services at their designated unit, a local "free world" facility, or at UTMB Health's Galveston Campus, which provides both inpatient and outpatient care within the Texas Department of Criminal Justice's Hospital Galveston (HG) and other campus clinics. "Delivering high-quality patient outcomes that improve health care delivery" represents one of the four strategic goals outlined in the University of Texas Medical Branch's (UTMB Health's) institutional vision, The Road Ahead. Attaining this goal requires communication and teamwork to identify and correct incidents and situations that impact or could jeopardize the safety of patients, visitors, and co-workers. To help facilitate its safety and clinical effectiveness efforts, UTMB Health utilizes a web-based incident reporting tool known locally as the "Patient Safety Net" (PSN). Reporting data received from the Quality Management Department's Risk Management division (Risk Management) indicates 439 HG-related events were reported during fiscal year (FY) 2015. As illustrated in the table at right, patientrelated events represented approximately 91% of the total reported. HG PSN Reported Events FY 16 m Pa\Jtrc!t Uns.1f Cond1tK>Os T V1 tof\ With a similar patient safety philosophy, CMC utilizes an online incident report form, accessible to users with access to the UTMB Correctional Managed Care website. The CMC online Incident Report Form (Form) is a version of the PSN incident reporting tool utilized to capture "patientonly'' adverse events. All UTMB CMC healthcare personnel involved in or witness of a patient incident (i.e. medication errors, falls, equipment failures, procedures) are advised to complete a Form as soon as possible after awareness of the event to ensure accurate information is captured. The database does not permit edits to the Form after submission by the user. The Quality & Outcomes for CMC departmental personnel are responsible for making changes in the event a change needs to occur. Medication errors and falls are the most commonly reported incidents by UTMB CMC nurses. CMC uses the Department of Veterans Affairs Healthcare Administration standard of 5.5 to benchmark their monthly and annual fall rates. Fall Rates as reported for FY 2016 are below the defined standard. Page 1of5

Ensuring a safe environment and healthcare experience for patients, visitors, and staff is critical to the overall success of UTMB Health. Audit Objective The primary objective of this audit was to assess the effectiveness of CM C's and HG's patient safety reporting processes by reviewing how incident reporting is recorded, monitored, addressed and communicated. Scope of Work and Methodology The scope of the engagement included review of the current patient event reporting processes in place for CMC units and Hospital Galveston (HG). Our audit methodology included interviewing key personnel; review of relevant documentation; and limited data analysis. Additionally, we relied on knowledge gained during the FY 2016 Patient Safety Net (PSN) Reporting Process Audit and the subsequent follow-up audit. The audit was conducted in accordance with the International Standards for the Professional Practice of Internal Auditing as promulgated by the Institute of Internal Auditors. Audit Results - HG HG - Recording Incidents UTMB Health Institutional Handbook of Operating Procedures (IHOP) policies, 9.13.13 Unusual Event Reporting and 9.13.16 Sentinel Events define unusual, sentinel and adverse events, as well as near misses. The Department of Quality and Healthcare Safety recently revised these policies based on recommendations from our prior audit. Currently, the draft policies are awaiting final approval for publishing to the Institutional Handbook of Operating Procedures (IHOP). HG - Addressing Incidents After submission, reported HG events are dispersed based on the nature and criticality /impact or "harm score" of the event within PSN to numerous institutional recipients, including the "Front Line Reporter's" manager. Additionally, PSN reports are reviewed, as deemed necessary, by unit nurse managers; Hospital Galveston-Based Clinical Leadership Team; Safety and Security Management Sub-Committee of Environment of Care (visitor related PSNs); Human Resources; various Quality Committees, and designated Health System Leadership. Risk Management and the HG Director of Patient Care Services and Assistant Chief Nursing Officer (CNO) review all HG related reported events, identifying the high harm critical events or events seeming unusual based on the reviewer's professional discretion. If a reported event (case) appears to be an event warranting further investigation, Risk Management performs an initial investigation of the event, which can include interviews with individuals involved in the event or those with pertinent knowledge and review of the medical record. A case synopsis may be prepared and presented to the Safety Event Action Team (SEAn for further review and discussion. SEAT may refer events to a department and/ or another committee for review or action according to the event scope of responsibility. SEAT reviewed three HG related incident cases during FY16. Page 2 of5

HG - Monitoring and Communication In addition to managing PSN reports, reviewing reported events for identified risks and investigating those events deemed critical, Risk Management monitors resolutions of SEAT follow-up items and, if necessary, will assist those responsible to accomplish resolution in a timely manner. Communication related to PSN reporting occurs on several levels. SEAT routinely reviews event trends and reports corrective actions to the Health System Executive Team. Risk Management prepares trend and detailed reports for various institutional committees and leadership. Additionally, Risk Management provides educational sessions and a periodic newsletter advocating safe health care practices. UTMB Health also reports key safety performance measures to several external groups including the Joint Commission and the Centers for Medicare and Medicaid Services (CMS). Communication back to the Front End Reporter rests with the reviewing Manager and Hospital Galveston-Based Clinical Leadership dyad. Staff meetings and daily communications with staff serve as platforms for discussing PSN reported outcomes and implemented processes resulting from PSN Institutional reviews. HG - User Account Management Risk Management serves as UTMB Health's on-site administrator for PSN, assigning event locations, deactivating users, and, assigning user specifications within the system. Our review of procedures performed by Risk Management for managing PSN user, administrative, and generic accounts noted they comply with prescribed governance as outlined in UTMB Health Practice Standard 1.2Account Management. Audit Results - CMC CMC - Recording Incidents The UTMB CMC Risk Management Program states that an on-going and proactive Risk Management program be established, maintained and supported to include a streamlined, easily accessible and well-communicated process for all UTMB CMC employees to identify and report instances. CMC provides an online guide instructing the user on the purpose of and assistance of Form completion. CMC - Addressing Incidents Once submitted, CMC Forms accumulate in a database accessible by the Quality & Outcomes for CMC departmental personnel. The Program/Case Manager (or back-up) reviews each Form submitted for completeness. The Unit Nurse Manager receives an electronic non-editable copy of the completed Form for review purposes. The Program/Case Manager discusses sentinel rated incidents promptly to the Director for review and informs additional CMC Leadership and the Executive Quality Council (EQC), as needed. If a root cause analysis (RCA) is deemed necessary, the Program/Case Manager will perform one and create an agreed upon plan for the Unit to report to the EQC for approval. Page 3of5

CMC - Monitoring and Communication The EQC receives and reviews reports for medicine errors and falls on a monthly and quarterly basis. The Quality & Outcomes for CMC department is not involved with activities beyond reporting to Leadership. Education/training opportunities are responsibilities left to the discretion of the Units involved. CMC - User Account Management The CMC Form is accessible by any user with access to the TDCJ website. As communicated to, once submitted the Form is only accessible by one of three individuals in the Quality & Outcomes for CMC department. UTMB Health Information Systems (IS) designed the Form and related database in this manner. was unable to obtain any documentation verifying the number of user accounts with access to the database. However, the application resides on a CMC specific network and access from connections external to that CMC network is restricted. Additional inquiry regarding network security resulted in the determination that the application is running on Windows 2003 operating system (OS). UTMB Health IS considers this OS an "end of life" high-risk system with multiple vulnerabilities. The Quality & Outcomes for CMC department currently has no ability to add/change/delete user accounts. interviews with IS and CMC personnel indicated there was an unexpected change in the System Administrator role in June 2016 resulting in the loss of system knowledge, access, and capabilities. Our review identified to the department a need to gain password-protected access to this system, a better understanding of system functionality and consider implementation of a best practice succession plan for future turnover. The Programmer/ Analyst is in current discussions with UTMB-Health IS to determine what action steps to perform. Additional items relate to user Account Management. The CMC system is in scope for further examination by Information Technology team in its upcoming System Authentication audit. Recommendation 2017-012-01-RM: CMC IS leadership, working with UTMB-Health IS leadership, should develop and implement a plan to upgrade the operating system that the CMC Incident Report database currently utilizes. Management's Response: We agree with Recommendation 2017-012-01-RM and are working with CMC IT to address the operating system upgrade suggested. Given the current availability of resources and existing staff the timeline will be a minimum of 12 months for completion. Implementation Date: March 2018 Page 4of5

Recommendation 2017-012-02-RM: CMC IS leadership, working with UTMB Health-IS department, should gain appropriate access to the database and design a plan for on-going system maintenance. Management's Response: We agree with Recommendation 2017-012-02-RM and are working CMC IT and UTMB Health-IS to address both the database access and on-going maintenance. Given the current availability of resources and existing staff the timeline will be a minimum of 12 months for completion. Implementation Date: March 2018 Conclusion Hospital Galveston, in conjunction with UTMB Health, and CMC have appropriate processes in place for the reporting, addressing, monitoring and communicating of patient safety events. Opportunities exist to strengthen security to the reporting database and provide system maintenance as appropriate. We greatly appreciate the assistance provided by personnel in CMC, TDCJ Hospital Galveston and the Department of Quality & Healthcare Safety and hope that the information presented in our report is beneficial. Kimberly K. Hagara, CPA, CIA, CISA, CRMA Vice President, Barbara L. Winburn, RHIA, CIA, CRMA Senior Manager Pages of5