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

Table 2 Measures in External Quality Assessment

	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)

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

ISSN: 1475-2875