ISO Accredited Laboratory
Everight Diagnostic & Laboratory Services Ltd, Abuja, Nigeria, is now an ISO 15189 accredited Laboratory.
Healthcare delivery is no longer a simple process of examining the patient and giving him or her drug prescription. Over the years, there has been rapid development in the various branches of clinical and diagnostic medicine. As part of this expansion process and explosion of scientific medical knowledge, laboratory diagnosis has gained tremendous importance in today’s evidence-based practices. In order to dovetail our services with international best laboratory practices and standards, we recognized the implementation of a quality management system in accordance with ISO 15189, as a non-negotiable pathway to quality and competence that would guarantee patients’ safety and users’ satisfaction. The patient or client is the epicentre of such a system as it is primarily designed to satisfy customers’ health needs through the application of the system, assessment of the system, continuous improvement of the system, prevention of the occurrence of nonconformities, ensuring the competence of staff and maintaining both analytical quality and quality assurance. These, among other things we have consistently done at Everight Diagnostic & Laboratory Services Limited situated at No 2 Fez Street, Off Kumasi Crescent, Wuse 2, Abuja, which earned the laboratory the recent award of ISO 15189 ACCREDITATION as announced by the federal government of Nigeria through the Medical Laboratory Science Council of Nigeria.
Ever since the announcement, people have been curious to know what it means and how it would benefit laboratory users – patients and healthcare providers. This article is therefore written to educate the people on the subject.
The International Standard ISO 15189 is the gold standard for accreditation of medical laboratories, covering both management and technical requirements needed for assessing the competence of the personnel and the quality of their services. Therefore, the ISO 15189 accreditation is an assurance that the laboratory has been assessed against internationally recognized standards aimed to prove the existence of a quality system and technical competence, and that the personnel is proficient in generating technically valid results and suitable information for the intended use of each test.
This Standard requires, for example, the implementation of criteria and procedures to assure appropriateness of test requests, how the laboratory guarantees its effective contribution to the interpretation of results, and how concordance of interpretation among different physicians can be granted. Beyond medical skills, the competence of all the professionals working in the laboratory (e.g. medical laboratory scientists, technicians, and data analysts) is needed. The evaluation of analytical interference, performance characteristics, quality indicators, the estimation of measurement uncertainty, and participation in External Quality Assessment Schemes (EQAS) are key activities performed by laboratory practitioners. The calibration and verification of pipettes, providing the procedures for instrument maintenance or validation of Internal Quality Control (IQC) are examples of practical activities performed to enhance the competence of laboratory practitioners.
In conclusion, the ISO 15189 accreditation recognizes world-class quality practices in the laboratory and the application of a rigorous process of quality assurance in the interest of patients. The ISO 15189 accreditation improves the accountability of the staff and gives the public confidence that the quality system will identify mistakes before they affect patient care.