ISO 15189

Steps To Compliance

The medical laboratory plays a critical role in high quality patient care. The laboratory's aim is not to simply provide reliable results to assure the safety of the patient, but to do so within a reasonable turnaround time, with traceability for all lab procedures and with respect to ethics. Given the importance of laboratory output and the potential harm of incorrect laboratory results, worldwide opinion leaders in the laboratory profession feel there is a need for an internationally recognized standard of practice for medical labs. ISO 15189 accreditation is a “procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks” [ISO/IEC Guide 2]. This accreditation is an acknowledgement that your lab observes those recognized standards and practices that are so critical to assuring the safety of the patient.
ISO15189 - Subclause 5.6.3
“The laboratory shall participate in an interlaboratory comparison programme(s) … that substantially fulfill the relevant requirements of ISO17043”
“Whenever an interlaboratory comparison is not available, the laboratory shall develop other approaches…”

Unity Interlaboratory Program & External Quality Assurance Services

Participation in a well established interlaboratory program is critically important for laboratories to help assess the reliability and precision of testing systems. An interlaboratory program can help labs identify shifts and trends that may have otherwise gone unnoticed, helping verify the reliability of laboratory testing. Pairing interlaboratory participation with EQAS programs designed to improve laboratory proficiency can have a tremendous impact on laboratory performance.

ISO15189 - Subclause
“Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”
“The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples.”

Independent Third Party Controls

Independent Quality Control Materials are an essential part of the laboratory’s quality control system. When constituted from a human base matrix, independent control materials are similar to patient samples. Because they are manufactured independently of the instrument, reagents and calibrators, they may provide better assessment of the test system’s reliability. Best of all, many independent controls offer a long shelf life which allows the same quality control to be used across multiple reagent lots to reduce cross over studies and to detect shifts that may occur with new reagents and calibrators.

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
“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.