ISO15189 - Subclause 4.14.6
“The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken.”
Bio-Rad Mission: Control
Bio-Rad Mission: Control is a tool for labs interested in improving patient safety through implementing QC strategy based on a quantitative assessment of patient risk. With Bio-Rad Mission: Control, laboratories may better assess their current risk of reporting incorrect patient results, by quantifying the likelihood and severity of harm associated with reporting an incorrect result. Labs can evaluate the impact of work process and potential failures on patient safety, then document decisions and actions taken to reduce patient risk, simplifying regulatory compliance. After determining how much patient risk exists in their current quality system, Bio-Rad Mission: Control recommends an approach to reduce that risk through implementing a proper Quality Control Plan.
ISO15189 - Subclause 5.6.2.3
“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure.”
Data Management Products & Connectivity Solutions
Bio-rad offers a comprehensive portfolio of QC Data Management Solutions designed to improve laboratory analytical performance and optimize workflow. Our connectivity solutions allow your lab to connect instruments into one streamlined workflow, transcribing data easily, automatically and error free. With a Connectivity solution in place you’ll be able to harness the full power of Unity Real Time. Analyze up to the minute QC data and make run-time decisions in real-time. Bio-Rad’s QC Data Management solutions are designed to help you work proactively identifying trends and making corrections before results are compromised, helping your organization achieve its quality goals efficiently and effectively.