Microbiological Assessment Of Quality Control In Governmental Laboratories In Khartoum State2016

Abstract

Quality is an important issue in medical laboratories, it leads to right and trusted results, which will guide the doctor and patient to the right treatment without wasting time and money, and then it will lead to healthy individuals and communities. In this study, we assessed the quality measures in eleven microbiology laboratories in Khartoum State hospitals by applying the standard clauses of ISO 15189 and checking the reproducibility of these laboratories by using three NCTC/ATCC different organisms with different properties. The objective of this study

was to assess the implementation of quality control standards in the

governmental microbiology laboratories in Khartoum State.

This is non-interventional (Observational) Descriptive – cross sectional design study was conducted between January to March 2016.Three standard organisms(S.aureusNCTC12903/ATCCR27853),(E.coliNCTC12241/AT CCR25922),( Ps.aeruginosa NCTC12973/ATCC R 29213) distributed to check the reproducibility and sensitivity tests. ISO 15189:2007 checklist

was used to assess the managerial and technical clauses applied inside these laboratories. SPSS and excel programs were used to analyze the data. The results introduced in tables.

The results showed that the percentage of applied clauses of ISO 15189 checklists was between 34% to 64%.The Equipment 54.4% were old (not automated).Laboratories personnel have 52.5% from the international standards. Reagents and Supplies have 66% .The pre-analytical was the main source of false results 55.7% while the analytical was having 65% and the post analytical was having 75%. Personnel 52.5% no continuous education program available for the staff, no procedure to control personnel performance and no records maintained for all the staff. Equipment 54.4% Laboratories not furnished with all equipment required

for services just it were finished with bacteriology equipments,

Instruments had no documented maintenance, no verifications labels. The quality assurance applied partially 32.1%. Reproducibility: Twenty-four out of thirty-three were correct final identification answers 72.7%. There

should be written strategies for antibiotic sensitivity tests. Assuring

quality was 32.1% and continuous improvement was 30.4%, clauses were poorer. Documents 44% were not an important issue inside the laboratories. Internal audit 67.5% is functionless and with no impact if was done because there were no adopted appropriate corrective and preventive actions. The identification results received for the three standard organisms

(NCTC/ ATCC) types; One hospital 9.1% failed to provide identification result for the three organisms because it was not having biochemical test sets. One result 3% was false microscopical result (Gram positive instead of Gram negative). Five results 15.2% had nomenclature error they wrote the genus without species. Nine final identification results 27.3% were false. The antibiotics susceptibility tests results indicate that one laboratory 9.1% used multidisc for Gram negative and positive bacteria. The study showed that: all these laboratories need to review their quality management system, policies, procedures, and processes to control the testing activities