External Quality Assessment Automated Laboratory Joseph Murray - PowerPoint PPT Presentation

External Quality Assessment Automated Laboratory Joseph Murray

What is External Quality Assessment? EQA – “is a program in which multiple samples are periodically sent to members of a group of laboratories for analysis; whereby each laboratory’s results are compared with those of other laboratories in the group and/or with an assigned value, and reported to the participating laboratories and others.”

Some key points... • Analyte value unknown to participants prior to analysis • EQA specimens should be analysed using exactly the same process as patient specimens • Allows for inter-laboratory comparison of reagents, methods, instruments • The data is kept confidentially from other participants ensuring anonymity • Unlike Internal Quality Control (IQC) which provides an indication of how an assay is performing in real-time the results of EQA are retrospective • EQA schemes are available for most of the tests available across all disciplines in pathology • Provided by a number of different organisations • In Clinical Chemistry mainly focus on the analytical process and method performance – rather than pre- and post-analytical phases • Participation in EQA schemes is a requirement for UKAS accreditation

An overview of the EQA Process... External Quality Assessment External Quality Assessment Scheme PROVIDER Scheme USER 1. Clinical material dispatched 2. Clinical Material received to the USER laboratory by the USER laboratory 3. Clinical material examined 5. RESULTS from all by the USER laboratory and participating USER laboratories the results recorded analyzed and a report indicating the performance of an individual laboratory's performance in relation the performance of all 4. Examination results participating laboratories returned to the External Quality Assessment scheme PROVIDER 6. Report indicating the 7. USER laboratory reviews its performance of an individual performance in relation the to the USER laboratory's performance performance of all participating in relation to the performance of laboratories and takes action to all participating laboratories remedy any problems

Why do it? QUALITY ASSURANCE!!!!!! EQA is one facet of QUALITY ASSURACE. In addition to IQC, health & safety, clinical governance , training & competency and audit it helps us as a service to achieve our QUALITY goals and form part of the laboratory’s Quality Management System (QMS). Further info can be found in the laboratory ‘Quality Manual’ - PROC-G-QualMan - on iPassport!

How does EQA fit into the overall Quality framework in UK Pathology? National Quality Assurance Advisory Panels (NQAAPs) (discipline specific experts) oversee EQA schemes and set performance criteria. EQA schemes should be accredited by UKAS to ISO standard 17043 Joint Working Group for Quality Assessment (JWGQA) (multidisciplinary group within RCPath), ultimately responsible for EQA schemes

So what happens when performance is poor? If issue fails to get JWGQA (no mandatory powers) contact resolved passed to relevant hospital CEOs and reports to Care JWGQA Quality Commission (CQC) and UKAS!!! Lab reported to relevant NQAAP if fails to engage with EQA provider/improve performance When performance poor EQA provider works with lab to improve Performance criteria differs between EQA providers – performance standards not harmonised

Automation EQA Schemes... Provider Scheme Analyte Distribution Frequency AFP, CEA & hcG AFP, CEA, HCG Monthly Antibiotic Assays Gentamicin, Vancomycin, Amikacin, Tobramycin Monthly Albumin, ALK, ALT, Amylase, AST, Bicarbonate, Calcium, CK, Cl, Creatinine, GGT, Clinical Chemistry Glucose, Iron, K, LDH, Lithium, Mg, Na, Osmolality, Phosphate, Tbil, TP, Urate, Bi-weekly Urea CRP CRP Monthly Fructosamine Fructosamine Monthly Peptide Hormones FSH, LH, Prolactin Monthly Pregnancy Testing HCG-Urine NEQAS PTH, ACTH, hCT PTH Bi-Monthly Carbamazepine, Digoxin, Ethanol, Lithium, Paracetamol, Phenobarbitone, Salicylate, Paracetamol, Ethanol Monthly Phenytoin, Salicylate, Theophylline, Valporate A1 antitrypsin, Caeruloplasmin, Haptoglobin, IGA, IGG, IGM, Orosomucoid, Specific Proteins Transferin, Cortisol, DHAS, Female Testosterone, Male Testosterone, Monthly Oestradiol, Prgesterone, SHBG Thyroid Hormones FT3, FT4, TSH Monthly ACR, Albumin, Amylase, Calcium, Cl, Creatinine, Glucose, K, Mg, Na, Osmolality, Urine Chemistries Monthly PCR, Phospate, TP, Urate, Urea eFGR Creatinine, eGFR Monthly NEQAS – Cardiac Cardiac Marker Troponin T Monthly Marker CSF Biocehmistry Glucose, Lactate, TP Bi — Monthly NEQAS -IMMQAS PSA PSA Monthly Tumour Markers CA125, CA153, CA199 Bi-Monthly Ammonia Ammonia Monthly Bile Acids Bile Acids Monthly Bilirubin Dbil, Tbil Monthly WEQAS Lipids Cholesterol, HDL, LDL, Trigs, LPA Monthly NT PRO BNP BNP Bi-Monthly Serum ACE ACE Bi-Montlhy

The Process – Booking To Submission

Booking In • EQA specimen labelled (primary/secondary tube and paperwork) and booked in by trained member of staff in specimen reception • Specimen treated like external laboratory requests – ‘EQA’ entered as ‘Requesting Source’ • Each scheme allocated unique patient registration number with demographics providing additional info. E.g. • Under ‘Specimen Comments’ distribution number and Sample number entered • A number of test super-sets have been created for each scheme Procedure outlined in SOP ‘Booking in External Quality Assurance Samples’ - PROC-CB-H5.3/Booking - on iPassport!

Sample Processing • Once labelled and booked Specimen Reception pass specimens (with paperwork) to Automated laboratory • Important to analyse EQA samples on day of receipt – if not possible should be stored appropriately and delay in analysis recorded on paperwork • Any preparation instructions provided should be adhered to ‘exactly.’ Especially important when reconstituting lyophilised samples e.g.

TROPONIN... Reconstitution instructions for Troponin EQA

Sample Processing • Once labelled and booked Specimen Reception pass specimens (with secondary tubes and paperwork) to Automated laboratory • Important to analyse EQA samples on day of receipt – if not possible should be stored appropriately and delay in analysis recorded on paperwork • Any preparation instructions provided should be adhered to ‘exactly.’ Especially important when reconstituting lyophilised samples e.g. Troponin • Once prepared samples transferred to labelled (bar-coded) secondary tube for analysis – transfer just enough for analysis so that remainder in primary tube can be stored • Ensure specimens placed on correct analyser – special consideration should be made when analysing NEQAS General Chemistry distributions...

CITY General Chemistry EQA:

CITY General Chemistry EQA: Two sets of specimens received for NEQAS General Chemistry Distributions per site Need to examine test requests on each sheet and decide most appropriate analyser for analysis!!!! Ideally each set should be analysed on SAME analyser every distribution – this allows performance issues to be correctly attributed to specific analysers Any discrepancies (i.e. moving samples between analysers to complete requests) should be raised with Section Senior. Set repertoire can be updated with NEQAS for subsequent distributions Best practice to record on distribution sheet which analyser(s) was (were) used for analysis Which Analyser Would You Use To Analyse These Specimens?

Post Analysis • Check the specimen in Telepath. Ensure all requests have been completed... • Check the EQA distribution sheet against what has been booked in on Telepath. Ensure no requests have been missed!!!! Better to resolve problems now, rather than having to locate specimens later!

Transcription of Results • Once analysed results manually transcribed onto distribution sheet • Transcribe all results from Telepath system to sheet!!! Complete ALL relevant fields e.g. Date of receipt/analysis, storage conditions, kit/calibrator lot number

Transcription of Results • DON’T transcribe directly from analyser screen - units and decimal places may be different!!!

Retention of Specimens & Paperwork • Completed samples stored in ‘ Complete EQA Draw ’ on bottom shelf of ‘ QC Fridge ’ at Sandwell and ‘ EQA draw ’ in Freezer in old Haemoglobinopathy lab at City • Ensure when placing specimen into specimen bags that lids are tightly in place to prevent spillage!!! • Once reports have been returned from Scheme Provider EQA specimens at Sandwell are moved to Freezer in Manuals lab. At City EQA specimens are moved from Freezer in old Immunology Automation lab on a monthly basis and retained in appropriate rack for period of three months • The paperwork is placed in the ‘ EQA tray ’ mounted on the wall at Sandwell and in the tray on the cabinet bellow the Communication Screen at City ready for submission • Paperwork should NOT be transported across site so as not to go astray!!!