An accredited laboratory inspires confidence in its customers. Laboratory accreditation is the internationally accepted framework for increasing test quality and the frequency of laboratory errors. In order to pass accreditation, the laboratory must fulfil a set of requirements mandated by the accrediting body.
Laboratory standard organizations throughout the world set forth in published standards the requirements mandated by accrediting organizations. Using standards ensures that the laboratory is implementing the steps that the accrediting agency requires. Another goal of using published standards in the laboratory is to ensure that procedures and processes are performed the same as in every laboratory that implements the standard. Errors that result in wasted time and money and can lead to patient harm are reduced. Some standards offer broad-based information on what the laboratory needs to do to satisfy the requirements of the accreditor.
The management of Melsta Labs has worked towards becoming a highly accredited laboratory since its inception. We have partnered with 5 International External & Internal Quality controls for almost all parameters by External Quality Assurance providers.
Medical laboratories is accredited by SLAB for ISO15189:2012. Medical laboratories require competence, to demonstrate the quality and reliability of their services. ISO 15189 was developed with the participation of the medical, scientific, and clinical community. This standard contains requirements for diagnostic labs to demonstrate competence to deliver, timely, accurate, and reliable results.
SLAB accredits medical laboratories against the international standard ISO15189, which specifies the global requirements for quality and competence. SLAB accreditation provides reassurance to patients, regulatory bodies and healthcare providers of the quality of a diagnostic service. Through independent and impartial evaluation against recognized standards, accreditation seeks to validate and recognize success, as well as drive up the quality and consistency of service delivery by aspiring towards excellence with quality patient outcomes at its core. ISO 15189 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors. Qualified assessors conduct a thorough evaluation of all factors affecting the production of test data.
To ensure continued compliance, SLAB accredited laboratories are regularly reassessed to check that they are maintaining their standards of technical expertise. These laboratories will also be required to participate in regular proficiency testing programs (known as external quality assurance programs or EQAS) as an on-going demonstration of their competence.
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.