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      Factors influencing the high rejection rates of HIV 1/2 serology samples at Charlotte Maxeke Johannesburg Academic Hospital and the cost implications

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          Abstract

          Background

          HIV enzyme-linked immunosorbent assay (ELISA) is one of the most requested test sets within Virology and forms an essential part of patient management. Assessment of the rejection criteria is a key quality indicator, crucial for improving laboratory services and efficiency to ensure accurate and reliable results.

          Objectives

          The aim of this study was to identify the factors that influence the HIV 1/2 serology rejection rates (RR) at Charlotte Maxeke Johannesburg Academic Hospital and to evaluate the associated costs.

          Methods

          A retrospective study was conducted (June to December 2019) to identify the RR and rejection criteria of HIV serology samples throughout the total testing process. Descriptive analysis using percentages and frequencies was used to analyse the RR by phase, health establishment, ward and healthcare professional. A cost analysis incorporating minor and major costs was modelled in each phase of testing, and the total cost of rejections was calculated.

          Results

          A total of 6678 tests were received, and 738 were rejected (RR = 11.1%). The pre-analytical phase contributed significantly to the overall RR, with the requirement of a separate sample (57.44%) the most common reason for rejection. The total cost per rejected test was $2.47, which amounted to a total rejection cost of $197.55, of which $158.18 was caused by the pre-analytical rejection criteria.

          Conclusion

          High RR of HIV tests were noted, resulting in significant cost wastage. Identification and analysis of rejections must be implemented across all laboratories to improve the efficiency of testing, provide a cost-saving benefit and maintain high laboratory standards.

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          Most cited references27

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          Preanalytical quality improvement: from dream to reality.

          Abstract Laboratory diagnostics (i.e., the total testing process) develops conventionally through a virtual loop, originally referred to as "the brain to brain cycle" by George Lundberg. Throughout this complex cycle, there is an inherent possibility that a mistake might occur. According to reliable data, preanalytical errors still account for nearly 60%-70% of all problems occurring in laboratory diagnostics, most of them attributable to mishandling procedures during collection, handling, preparing or storing the specimens. Although most of these would be "intercepted" before inappropriate reactions are taken, in nearly one fifth of the cases they can produce inappropriate investigations and unjustifiable increase in costs, while generating inappropriate clinical decisions and causing some unfortunate circumstances. Several steps have already been undertaken to increase awareness and establish a governance of this frequently overlooked aspect of the total testing process. Standardization and monitoring preanalytical variables is of foremost importance and is associated with the most efficient and well-organized laboratories, resulting in reduced operational costs and increased revenues. As such, this article is aimed at providing readers with significant updates on the total quality management of the preanalytical phase to endeavour further improvement for patient safety throughout this phase of the total testing process.
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            • Article: not found

            Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories.

            Prevention of medical errors is a major goal of healthcare, though healthcare workers themselves have not yet fully accepted or implemented reliable models of system error, and neither has the public. While there is widespread perception that most medical errors arise from an inappropriate or delayed clinical management, the issue of laboratory errors is receiving a great deal of attention due to their impact on the quality and efficiency of laboratory performances and patient safety. Haemolytic specimens are a frequent occurrence in clinical laboratories, and prevalence can be as high as 3.3% of all of the routine samples, accounting for up to 40%-70% of all unsuitable specimens identified, nearly five times higher than other causes, such as insufficient, incorrect and clotted samples. This article focuses on this challenging issue, providing an overview on prevalence and leading causes of in vivo and in vitro haemolysis, and tentative guidelines on identification and management of haemolytic samples in clinical laboratories. This strategy includes continuous education of healthcare personnel, systematic detection/quantification of haemolysis in any sample, immediate clinicians warning on the probability of in vivo haemolysis, registration of non-conformity, completing of tests unaffected by haemolysis and request of a second specimen for those potentially affected.
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              Exploring the iceberg of errors in laboratory medicine.

              The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories, and currently available evidence demonstrates that the pre- and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. In particular, most errors are identified in pre-pre-analytic and post-post analytic steps outside the walls of the laboratory, and beyond its control. However, in a patient-centered approach to the delivery of health care services, there is the need to investigate any possible defect in the total testing process that may have a negative impact on the patient. In fact, in the interests of patients, any direct or indirect negative consequence related to a laboratory test must be considered, irrespective of which step is involved and whether the error is caused by a laboratory professional (e.g., calibration or testing error) or by a non-laboratory operator (e.g., inappropriate test request, error in patient identification and/or blood collection). Data on diagnostic errors in primary care and in the emergency department setting demonstrate that inappropriate test requesting and incorrect interpretation account for a large percentage of total errors whatever the discipline involved, be it radiology, pathology or laboratory medicine. Patient misidentification and problems in communicating results, which affect the delivery of all diagnostic services, are widely recognized as the main goals for quality improvement. Therefore, some common problems affect diagnostic errors, although specific faults characterising errors in laboratory medicine should lead to preventive and corrective actions if evidence-based quality indicators are developed, implemented and monitored. The lesson we have learned is that each practice must examine its own total testing process to discover its weaknesses and identify appropriate remedies.

                Author and article information

                Journal
                South Afr J HIV Med
                South Afr J HIV Med
                HIVMED
                Southern African Journal of HIV Medicine
                AOSIS
                1608-9693
                2078-6751
                11 January 2022
                2022
                : 23
                : 1
                : 1326
                Affiliations
                [1 ]Department of Virology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa
                [2 ]National Health Laboratory Service, Johannesburg, South Africa
                [3 ]Department of Haematology and Molecular Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
                Author notes
                Corresponding author: Bhaveshan Reddy, reddybhaveshan@ 123456gmail.com
                Author information
                https://orcid.org/0000-0002-4506-4361
                https://orcid.org/0000-0003-4389-2849
                https://orcid.org/0000-0002-0853-8011
                https://orcid.org/0000-0003-1064-3061
                Article
                HIVMED-23-1326
                10.4102/sajhivmed.v23i1.1326
                8832030
                242540ea-9fcf-4dd4-94a0-aa17610ec945
                © 2022. The Authors

                Licensee: AOSIS. This work is licensed under the Creative Commons Attribution License.

                History
                : 05 October 2021
                : 12 November 2021
                Categories
                Original Research

                hiv,rejection rates,cost analysis,laboratory,diagnostics
                hiv, rejection rates, cost analysis, laboratory, diagnostics

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