Quality assessment of sputum transportation, smear preparation and AFB microscopy in a rural district in Malawi.

SETTING: Ntcheu District, Central Region of Malawi. OBJECTIVES: To assess 1) the feasibility of introducing simple internal quality control procedures for acid-fast bacilli (AFB) microscopy, and 2) the quality of the district sputum smear microscopy service. DESIGN: A simple internal quality control system was piloted in which district laboratory staff assessed: 1) specimen suitability, 2) time between sputum submission and smear examination, 3) smear preparation and staining, and 4) microscopy. Actual times for processing specimens were compared with recommended times. External quality validation was carried out. RESULTS: Of 4805 sputum specimens: 1) documentation was complete in 95%, 2) 93% reached the laboratory within 7 days of collection, 3) 96% of smears were well prepared and stained, and 4) 97% concordance (96.4% smear-positive and 97.6% smear-negative) was demonstrated when 208 smears were re-examined by a second technician. The aggregate index of reliability was 86%. The mean time spent on microscopic examination was 3.8 minutes, compared with the recommended time of 10 minutes. When all smears from 164 patients were assessed externally, 98.2% concordance (98.1% smear-positive and 98.2% smear-negative) was demonstrated. False smear-negative and smear-positive rates were less than 2% each. CONCLUSION: District laboratory staff were able to incorporate simple quality control procedures for AFB microscopy into their routine practice, resulting in a reliable service. The lessons learnt are widely relevant and potentially useful for implementation of a national quality assurance scheme.