Supporting accreditation for new track-based haematology platform

With changing accreditation requirements for quality management in pathology laboratories, such as the transition from Clinical Pathology Accreditation (CPA) to ISO 15189 United Kingdom Accreditation Service (UKAS) accreditation, there is a great deal that the diagnostics industry can do to assist its customers. Although the transition from CPA accreditation is now officially complete, the new ISO 15189 quality standard requires a more comprehensive validation process for new equipment. Additionally, demonstration of continuing improvement and competence assessment within laboratories is required. Consequently, HORIBA Medical looks to support its customers fully and work in partnership with them to meet all quality standards. One such example follows the first global installation of HORIBA Medical’s new HELO high-throughput, fully automated haematology platform in Torbay Hospital (Fig 1), part of the Torbay and South Devon NHS Foundation Trust (TSDFT).

Validation support

This first successful installation of the HELO track-based haematology system follows a response to tender by HORIBA Medical in 2017 for a new fully automated haematology platform to replace Torbay’s 12-year-old Pentra DX 120 haematology analysers. Alongside the requirement for assistance in verification of the new system and ongoing assessment of competence via HORIBA’s Quality Accreditation Programme (QAP), other ‘must haves’ within the tender were robust white cell linearity, optical platelet counts and nucleated red blood cell counts.  In addition, Torbay was keen to have in place the very latest haematology technology, fully supported by a strong team of haematology experts.