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Table 2 Measures in External Quality Assessment

From: Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine

  Measure Organization # Samples and frequency In case of failure
Parasitology Grading of microscopists NICD 20 samples, 3 times per year Microscopist excluded from reading study slides for 4 months until re-trained and re-assessed
Biochemistry Pass/Fail1 RCPA, I-EQA 1 sample every 2 weeks 1 failure
        • Prepare deviation and action plan
        • Check internal QC
        • Run maintenance check and change reagents and controls
Haematology Satisfactory/ Unsatisfactory2 I-EQA 2 samples per month 2 failures
        • Prepare deviation and action plan
        • Check internal QC
        • Run maintenance check and recalibrate equipment
        • QA manager to double check QC for failed period
     All cases
        • Interrupt testing on failure equipment (use back-up)
        • If no equipment is operational, discuss possibility of interrupting vaccination
Bedside testing of glycaemia, base excess, lactacidaemia Pass/Fail Thistle (South Africa) 12 samples 2 times per year Corrective action implemented
Microbiology Graded 0-4, scores 0 and 1 reflecting low performance NICD 6 samples 3 times per year Prepare deviation and action planDiscuss with CLS Retrain staff (by site supervisors and CLS)
  1. NICD: National Institute of Communicable Disease; RCPA: Royal College of Pathology Australasia; I-EQA: International EQA; CLS: Central Laboratory Services (Johannesburg, South Africa); 1 criteria defined by International EQA and RCPA; 2 criteria defined by International EQA