Performance Evaluations of Four Basic Laboratory Tests Operated at Sub-District Health Promoting Hospitals in Northern Region of Thailand Through Proficiency Testing Scheme by Following ISO/IEC 17043

Abstract

This study evaluated the performances of four basic laboratory tests conducted at sub-district Health Promoting Hospitals (HPHs) in two health regions of the Northern Thailand. The tests consisted of blood glucose (BG) by blood glucose meter, hematocrit (Hct) by hematocrit centrifuge, urine biochemistry by urine test strip and pregnancy test by urine pregnancy test strip through the proficiency testing (PT) scheme according to ISO/IEC 17043:2010 guides for 2 rounds. Twelve processed blood and commercial quality control materials were used for performance evaluations. Homogeneity and stability of 4 parameters in 12 PT items were tested before sending the items to HPHs and at the end of PT schemes. Quantitative performances were statistically assessed according to ISO 13528:2015 using a z score, IzI ≤ 2.0, while qualitative performances using the mode group ± 1 level or ± 1 from the assay values in commercial package inserts as the satisfied performance. The results showed that the four parameters in most PT materials were homogenenous and stable, except for 8.3% hematocrit material (1/12) was not homogenous and 9.1% blood glucose material (1/11) was not stable. Satisfied performances of the four tests were 90% and ranged from 81.3% to 96.3%. However, over all poor performances were 10.0% and blood glucose by glucose meters represented an unsatisfied performance of 18.7%. A survey by questionnaire revealed inadequate quality control and assurance on hematocrit testing, no training in qualitative urine strip tests for HPH’s staff and the problems most frequently found were in blood glucose testing by glucose meters. In conclusion the four basic laboratory tests performed at HPHs in two health regions of the Northern Thailand were considered satisfactory by using acceptable homogeneity and stability materials through the proficiency testing scheme. However, there was still a need to improve the quality control system for the 10% of HPHs with poor performance.