IQC trending with unity software and evaluation of the bio-rad EQAS blood typing system

Abstract

Derby Teaching Hospitals NHS Foundation Trust provides both acute hospital and community based health services, serving a population of over 600,000 people in and around Southern Derbyshire. The Royal Derby Hospital, which incorporates the Derbyshire Children's Hospital, and is a busy acute teaching hospital. The Trust treats a million patients each year and more than 6,000 babies are born in its maternity unit annually. 72,000 elective operations take place every year in the hospital's suite of 35 modern operating theatres, an average of more than 280 operations per day. The hospital has a total of 1,100 beds. Pathology at the Royal Derby Hospital consists of three departments, Blood Sciences (Incorporating Haematology, Biochemistry, Immunology and Blood Transfusion), Cellular Pathology and Microbiology. The Blood Transfusion Laboratory is CPA Accredited, MHRA compliant, meets current BCSH Guidelines and participates in all relevant Quality Assurance schemes. The department processes around 60,000 blood group and antibody screens annually utilising two Biorad IH-1000 analysers and Biorad column technology. Routine Internal quality assurance is performed daily using the Biorad Basic QC package. Other tests performed are Antibody identification, Compatibility testing including serological crossmatch and electronic issue, Neonatal sample testing, Kleihauer testing and Direct Antiglobulin testing is undertaken. The department provides an Antenatal Screening Service and a routine Antenatal Anti-D prophylaxis (RAADP) programme. In January 2016 Bio-Rad installed a software package called Unity onto the Bio-Rad analysers for evaluation. Unity can be utilised to provide trend analysis/monitoring of sensitivity of the internal quality control material being processed routinely on the analysers. It is a requirement of the International Standard ISO 15189:2012 (E), 5.6.2.3 that: 'Quality control data shall be reviewed at regular intervals to detect trends in examination performance that may indicate problems in the examination system'. Initial results show that the Basic QC 1 & 2 cell samples in routine use on both the analysers appear to be stable throughout the period they are used maintaining consistent strengths of reaction for both grouping and antibody screening. Reports can be generated from the Unity software as PDF documents which are reviewed at local Quality meetings. Remote access for managers to the results on Unity via the hospital network is also a useful feature. In addition to evaluating the Unity software for IQC we were also involved in trialling the new Bio-Rad EQAS blood typing system. In February 2016 we received the first cycle of EQAS material which consisted of four blind samples, three samples suitable for Blood Grouping, phenotyping, antibody screening and antibody identification plus a further sample to act as a donor sample for compatibility testing. The samples were run routinely on the IH-1000 analysers and the results subsequently submitted before the closing date on the dedicated EQAS online portal via the Bio- Rad QCnet website. An EQAS online account was set up for the Derby Blood Transfusion Laboratory, which allowed us access to the portal to set up the instrument requirements (IH- 1000) and test requirements. Once the system was configured we could then enter the results for each test performed and submit the results accordingly. The report being made available 48 h later, which provided a comparison with other EQAS users using similar and alternative technologies. Further evaluation of the EQAS blood typing system will take place in Cycles 2 and 3 available in June and October 2016. (Table Presented).