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n Medical Technology SA - The impact of non-conformances on patient care at a pathology tertiary care laboratory in South Africa
Introduction Although several studies have reported that laboratory errors may have some effect on patient care, few have studied non-conformance reports specifically. Clinical governance is a framework through which laboratories can improve the quality of their service and boost high standards of patient care. One of the measures of achieving this is by the identification and control of errors. For the purpose of this publication, non-conformances will refer to the recognition and documentation of laboratory errors. They are activities that fail to conform to specified standards.
Methods This was a retrospective study of the non-conformance reports for five accredited pathology divisions (Chemical Pathology, Haematology, Medical Microbiology, Immunology, and Virology) at an academic tertiary laboratory of the National Health Laboratory Service, Tygerberg Hospital over a three year period. The medical records of patients that were directly implicated by the non-conformances were reviewed to determine the impact to their healthcare.
Results Five hundred and eighty-three non-conformance reports were recorded across the divisions with chemistry having 140 (24%), haematology 65 (11%), medical microbiology 122 (21%), virology 211 (36%) and immunology 45 (8%). Three hundred and sixty-eight (63%) non-conformances had a major impact on patient care such as: delay in treatment in 52 (20%) cases, specimen recollection in 27 (11%) cases, inappropriate or unnecessary therapy in 44 (17%) cases, and inadequate patient care in 56 (22%) cases.
Conclusion Although the data was limited by poor adherence to documentation, this could serve as a pilot study where laboratories can be encouraged to document non-conformance reports better so that the appropriate impact of non-conformances on patient care can be ascertained subsequently. With continuous quality improvement measures in the laboratory, more favourable patient outcomes are expected.
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