Cost effectiveness of quality control in bacteriology.

The cost effectiveness of quality control in bacteriology stipulated by regulators is not established. The authors evaluated 111 surveillance procedures applied to 54 different operations; 100 had been performed in the authors' lab between 1965 and 1980, 91 of which had been performed 50 times. Forty-six conformed to CLIA requirements (CLIA-P). Thirty-seven others were CLIA-P, which had been modified (CLIA-PM) by reducing frequency and extent because few or no deficiencies had been observed. Eight others were devised by the authors (HH-P). The number detecting deficiencies, the per cent, and the mean per cent of deficiencies detected were: CLIA-P, 31, 67%, 3.5%; CLIA-PM, 8, 22%, 2.1%; HH-P, 8, 100%, 8.8%. Compliance with CLIA would cost HH $20,700/year (3.4% of total bacteriology laboratory cost). HH-P would cost an additional $9000/year. Discontinuation of CLIA-P not detecting deficiencies would reduce HH costs by $2900/year. Application of other low yield CLIA-P only to new lots of selected dehydrated media and fresh batches of selected reagents would reduce cost further by $2000/year.