OTIS in the Media

Sept. 2015
MedicalLab Management
“Biologic Product Deviation Reporting in the Blood Bank”
By Randy German, MT(ASCP)SBB

March 2015
ADVANCE for Administrators of the Laboratory
“Panning for Gold in a ‘Just Culture’;
Nonconforming event reporting as a quality management cornerstone”
By Randy German, MT(ASCP)SBB

Aug. 8, 2014
CAP TODAY Recommends
“Webinar: Nonconforming event reporting

Sept. 2008
Transfusion (AABB Journal)
“Comprehensive Error and Accident Management Using Occurrence Tracking Information System (OTIS) Software” (AP 75) 48:277A
By R German, G Behr, A Shapiro, C Vanderree, K Austin, J Smith

Current good manufacturing practice requires an investigation of all deviations or unexpected events that have the potential to affect the safety, purity or potency of a blood component. Conducting thorough and well documented investigations and trending data can be challenging using a paper-based system.

We developed an occurrence tracking information system (OTIS) designed to ensure timely investigation, effective root cause analysis, user-friendly trending capability and complete regulatory documentation. OTIS is network-capable and stores data in a standard access database. The main screen is a log with user definable columns displaying key data elements which allow instant trending on any element. Detailed data for each report is organized into a tabbed folder structure with each tab containing required elements of the investigation. Green/red LED indicators for each data element indicate completion status.

Reports are reviewed on-screen by the Quality unit with focus on completeness of documentation, corrective actions and identification of trends and/or systems problems. Data can be easily sorted by key elements or filtered via an automated word search for instant trend analysis. Trends identified are targeted for competency assessments, systems changes, staff meetings, audits or other corrective actions. Inclusion and review of the involved sop(s) contributes to keeping them current and effective. Completion status display ensures all required steps are complete at which time a hard copy report is generated, reviewed and signed by the Medical Director.

OTIS is an effective tool for conducting thorough and meaningful occurrence reviews. This system ensures that the report is complete, provides an audit trail and facilitates easy review during meetings or regulatory inspections. Trending data is used to direct quality improvement, education, competency assessments and audits. Including employee statements and staff notifications have been key in root cause analysis, raising staff awareness of risk areas and gaining feedback for systems improvement.

Access full Transfusion abstract at Hoag/OTIS.

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