External Quality Assurance Programmes
We at Melsta Labs operate a number of Centres of Excellence, managed by renowned experts in Sri Lanka’s laboratory industry, and overseen by Specialist Consultants chosen from pioneer medical institutions in order to ensure accuracy and efficiency of the services we provide.
External Quality Assessment (EQA) / Proficiency Testing (PT) provide for the comparison of a laboratory’s testing procedures with those of other laboratories worldwide. These comparisons can be made to a peer group of laboratories or to a reference laboratory.
EQA involves the running blind patient-like samples and comparing results with that of peers in order to monitor retrospectively the accuracy of reporting. In order to further ensure confidence and reliability of the results, tests for EQA are run by the respective personnel who usually operate the device.
International Quality Assurance Programmes
Randox International Quality Assessment Scheme (RIQAS)
This is the world’s principal EQA scheme with more than 47,000 laboratory participants from over 139 countries. We are part of several EQA programmes including the Clinical Chemistry (Monthly) Programme along with the Haematology, Immunology, Coagulation Programmes and cardiac markers. Being part of such programmes aids in detecting faults in equipment and reagent, reviewing and carrying out staff training, improving laboratory analytical quality and even initiating and evaluating corrective actions. RIQAS provides user friendly reports that ease the evaluation of laboratory results while giving way to the comparative performance assessment of all laboratory systems.
External Quality Assurance Services (EQAS) by Bio-Rad
This range of programmes by the renowned Bio-Rad Laboratories, pioneer in manufacturing products for life science research and clinical diagnostics markets. EQAS programmes include reports on specimen packs and documentation with results being compared with peer laboratories that employ the same methodologies, instruments and reagents. We at Melsta Labs are proud participants of the Urine Chemistry and Haemoglobin programmes offered by EQAS.
R&D Systems is a registered Medical Device Establishment under the U.S. Food, Drug, and Cosmetic Act and is routinely inspected by the FDA. There In Vitro Diagnostic (IVD) products are manufactured under the Food and Drug Administration's Quality System Regulations and compliant with ISO 13485.Product quality is ensured from beginning to end with raw materials being controlled and inspected, in-process and final product testing against written specifications, and final inspection based on published sampling plans before a product is released for sale. Internal Quality Audits are performed periodically by qualified staff and vendor audits are performed on an as needed basis. Effectiveness checks are made through review and monitoring of product complaints, non-conforming materials, and corrective and preventative action programs.
CLINIQA corporation is a proven leader in clinical diagnostics with more than 40 years history manufacturing in-vitro diagnostic products. Their state-of-the-art cGMP facility, highly experienced personal, formulation expertise and regulatory compliance by maintaining the following certifications such as ISO 13485:2016, EN ISO 13485:2016, CE Mark and MDSAP. CLINIQA offers a comprehensive family of quality controls, calibrators, calibrator verifiers, and reagents available in various formats including liquid, lyophilized and powder. CLINIQA’s liquid products offer extended refrigerated stability.