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 SAMPLE XS-15- 01 (INR) NEQAS SAMPLE XS-14- 07 (INR) NEQAS SAMPLE XS-13- 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 USING KC4 NO OF REPEATS THAT WOULD BE NEEDED IF USING COAGUCHEK PRO 10 1 7 1 12 1 6 1 3 1 5

• 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