Beverley Straker-Bennett POCT Lead ADAS Blackpool Teaching - PowerPoint PPT Presentation

Beverley Straker-Bennett POCT Lead ADAS Blackpool Teaching Hospitals.

Current Liquid Thromboplast Reagent discontinued by supplier • Desire to improve the quality and reproducibility of the INR results by reducing • the complexity the complexity of the process Mandatory introduction of ISO 15189:2012 Medical laboratory standards and • ISO 22870:2006 POCT standards. Standardisation of methodology across the trust including cardiology. • Immediate result availability for Domiciliary visits. • Reducing operator errors and repeat INR tests . •

• Result not linked to patient specific identifier • Sampling errors • Cuvette / reagent preparation errors • Pipetting errors of blood into cuvettes • Reagent stability issues • No user log in / audit trail • No QC lockout / fail safe • Limited linearity / high no of repeats • Inability to upload results to EPR / Dawn • No audit trail of reagent lot used for result • Machine failure / printer failures

120,000 tests per year • 18 clinic sessions, 90-150 patients per session • 120 Domiciliary visits per day • Previously paid on block contract • New costs £ / test • 30 Coaguchek XS Pro / printers, cobas it 1000 • CCG discussions • Business case to trust • Procurement process •

OCT-NOV 2014 - Method evaluation of Thrombotrak DEC 2014 - Risk assessment JAN 2015 - Business case Full trial and evaluation of Coaguchek XS pro Costings FEB 2015 - Specifications developed MARCH 2015 - Procurement Implementation plans APR 2015 - Delivery of systems Staff training Competency assessment MAY 2015 - Validation of systems Domiciliary visits to go live JUN 2015 - Clinics to go live

53 ADAS patient samples • Run on the Coaguchek XS Pro systems, KC4 and a venous sample run on the • laboratory TOP analyser.

3 NEQAS samples; • low INR, therapeutic INR and higher INR • Run in replicate on the Coaguchek XS Pro devices. • NEQAS NEQAS NEQAS SAMPLE XS-15- SAMPLE XS-14- SAMPLE XS-13- 01 (INR) 07 (INR) 08 (INR) 4.1 1.3 2.2 4.1 1.3 2.2 4.0 1.3 2.2 4.1 1.3 2.1 4.0 1.3 2.1 4.0 1.3 2.1 4.2 1.4 2.2 4.1 1.3 2.2 4.0 1.3 2.2 4.1 1.3 2.1 4.1 1.4 2.1 4.1 1.3 2.2 MEAN INR 4.08 1.32 2.16 STANDARD DEVIATION 0.06 0.04 0.05 %CV 1.53 2.96 2.39 ACCEPATBLE INR RANGE 3.8-5.2 1.2-1.6 2.0-2.6

90% Reduction in clinic repeats Only repeat >5 (venous >8) • Error codes • Venous comparison for Anti phospholipid patients • NO OF REPEAT INR’S IN CLINIC NO OF REPEATS THAT WOULD BE NEEDED IF USING KC4 USING COAGUCHEK PRO 10 1 7 1 12 1 6 1 3 1 5 0

35 Staff BMS/ Nurse/ Mlas • 4 x 2 hours sessions • Roche trainer • Practical Demo • Competency assessment • Continuation training •

Link patient unique identifier directly to result • Full audit trail of users / tests / QC performed on the devices • QC performed / lockout facility • Result validation • Reagent pre acceptance / monitoring storage • QC review. • Monitored training and competency • Full validation of new systems • EQA •

User list / permissions / password lockout • Device management • Scanning of NHS barcodes • QC lockout • PAS feed for INR results to EPR • QC performance statistics • Reagent performance statistics • Auto re-certification of users • Validation of results / adherence to protocol •

3 Coagucheks per MLA • 2 MLA’s at most clinics • 90 -150 patients in each morning and afternoon session •

Compliance with ISO standards • Real time transmission of result into Dawn in the community setting • Real time dosing on Domiciliary visits •