Proper diagnosis of diseases is crucial to good healthcare outcomes. A wrong diagnosis can at best prove costly to the patient and at worst fatal. But despite the high stakes, diagnostic errors are not uncommon. Such mistakes creep into pathology and laboratory medicine.
A laboratory diagnostic error is one where a wrong laboratory result is given to a patient. It can also be defined as a laboratory result that does not meet expectations in terms of accuracy, timeliness, interpretation or does not reflect what is happening in the patient.
A wrong result can be due to a mistake happening at the time of sample collection, during measurement of the sample or when recording and communicating the patient’s result.
Such errors can be life threatening. For instance, about 30 percent of patients with tuberculosis are not diagnosed, contributing to the 1·5 million annual deaths globally.
Treatment without a confirmed laboratory diagnosis can also lead to the unnecessary use of antibiotics and antimalarial medications. There are also cases of people being wrongly diagnosed with HIV due to the use of unapproved test kits.
Usually, in the absence of good laboratory diagnostics healthcare providers rely on clinical judgment (syndromic diagnosis), an approach especially common at the primary healthcare level. Yet this treatment approach is dangerous as it assumes that diseases always present with very specific symptoms.
Lack of a systems approach to ensure diagnostic safety and quality can result in patient harm and wasting of resources.
A systems approach involves quality improvement processes that ensure equipment, staff and laboratory procedures are of the highest quality from the time of requisition of a test, to proper sample collection, transportation, processing, analysis, reporting of results, and dissemination of that result to the appropriate physician in a timely manner.
A breakdown in any of the above processes can cause diagnostic errors.
To reduce diagnostic errors, a national regulatory framework that addresses safety and quality is essential. New diagnostic tools and test assays should be validated against a gold standard and their use appropriately regulated.
Quality service implementation will require that the laboratory adheres to quality standards and regulatory authorities make it mandatory that each laboratory should be accredited for all the tests it performs and that each staff working within these laboratories has the requisite professional qualifications and competencies.
Advocacy for diagnostics to be an integral part of any universal health coverage programme should be a priority if we want to achieve SDG no 3.
Dr Shahin Sayed, chair, department of Pathology and Anatomic Pathologist, Dr Geoffrey Omuse and Dr Daniel Maina, Clinical Pathologists at Aga Khan University Hospital Nairobi
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