S3E4 - All you need to know about instrument validation.
Ask Stago (english version)
Shownotes Transcript
Welcome to Ask Stago, the podcast dedicated to provide expert answers to your expert questions in coagulation.
In today’s episode, our guest Kaitlyn Pelc will explain further the different steps to validate an instrument at the installation.
Previous episodes in relation to the topic:
S2E18 – Practical check list of the implementation of an instrument in your lab: https://www.podcastics.com/podcast/episode/s2e18-practical-check-list-of-the-implementation-of-an-instrument-in-your-lab-103649/)
S2E3 – How to establish and control the reference range of my assay: https://www.podcastics.com/podcast/episode/s2e3-how-to-establish-and-control-the-reference-range-of-my-assay-60155/)
S2E2 - How to calibrate your reagent as a pro: https://www.podcastics.com/podcast/episode/s2e2-how-to-calibrate-your-reagent-as-a-pro-58249/)
Literature sources:
CLSI. Protocol for the Evaluation, Validation and Implementation of Coagulometers; Approved Guideline. CLSI document H57-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
CLSI. One-Stage Prothrombin Time (PT-Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline- Second Edition. CLSI document H47-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
CLSI. Procedures for Validation of INR and Local Calibration of PT/INR Systems; Approved Guideline. CLSI document H54-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
CLSI. Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition. CLSI document EP28-A3c. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
CLSI. Measurement Procedure Comparison and Bias Estimation Using Patient Samples. 3rd ed. CLSI guideline EP09c. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.
CLSI. User Verification of Precision and Estimation of Bias; Approved Guideline- Third Edition. CLSI document EP15-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
College of American Pathologists. All Common Checklist. Northfield, IL: College of American Pathologists; 2021.
Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.