Ensuring reagent quality is essential to protect the unique specimen and achieve an accurate diagnosis.
ISO 15189:2022 states that:
“The laboratory shall have processes for the selection, procurement, reception, storage, acceptance testing and inventory management of reagents and consumables.”
“a new lot or shipment, shall be verified for performance before placing into use”
“Consumables that can affect the quality of examinations shall be verified for performance before placing into use.”
Carrying out acceptance testing of formalin, xylene and alcohol to ensure the reagents are fit for purpose has been a difficult and time consuming process, until now! AnatoPath are proud to introduce you to our range of QA products. These products are designed specifically to identify breaches in quality that put patient samples at risk.