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The design of Quality Management System is based on norms laid down by Oncquest, which are in conformity with the ISO: 15189: 2007 standards of Medical Laboratory Management Systems, College of American Pathologists (CAP) and NABL requirements.
The system reflects the organization’s desire to be ‘Best-in-Class’ and incorporates the twin objectives of ‘customer satisfaction’ and ‘continual improvement’ into the organization’s operations.
Important elements of Quality Management System include:
Quality Assurance +
- Documentation: At Oncquest we ensure that the Quality Management System laid down and structure of documentation is as per the requirement of International guidelines of ISO 15189 and CAP. We ensure that day to day records are being documented and stored for easy retrieval and future reference.
- Standard Operating Procedures (SOP’s): The SOPs that form a part of Documentation are laid down and implemented to cover all the requirements of ISO 15189 and CAP.
- Quality Control samples: At Oncquest we ensure that calibrations are performed and quality control samples are analyzed and studied for performance of the method and instrument before we analyze any patient sample so as to meet the twin principle of Quality Assurance – ‘Fit for purpose” and “Right first time”.
- Maintenance and Calibration: At Oncquest care is taken to choose the instruments and equipments based on specific requirement of the scope. All the instruments are regularly maintained and calibrated to ensure the reliability of the analysis / results.
- External Quality Assessment Scheme: Oncquest participates in various National and International Proficiency Testing programs which includes but are not limited to CAP, AIIMS, Bio-Rad etc
Quality Control +
Quality Control procedures are used in each assay to assure that the test run is valid and results are reliable; which includes:
- Kit Controls
- Quality Control Samples
- Validation and Verification Studies
The frequency of analyzing the quality control samples as per recommendation by the ISO 15189/ NABL 112/ GCLP and manufacturers recommendations.
Quality Control plans have been laid down and implemented to ensure the accuracy of the entire testing process from receipt of sample and testing of sample to reporting of results;
Quality Control Plan laid down for Sample Reception includes but is not limited to sample reception. Verification of requisition, sample conditions and availability of services and action plan in case of any discrepancy
Quality Control Plan for technical sections includes Reception, Analysis, Quality Control and Reporting of results at the respective sections of the laboratory and action plan in case of any discrepancy.
At Oncquest Validation and verification of method/ test /instrument is performed as per guidelines of CLSI/CAP/ various other international guidelines to ensure the accuracy and reproducibility of test method before it is implemented for Patient Testing.
Quality Assessment & Quality Improvement +
Quality Assessment:
At Oncquest we ensure that the QMS laid down is assessed at fixed intervals to ensure that is meets the compliances and requirements through Internal Audits, External Audits and Accreditation Audits.
Quality Improvement:
At Oncquest continuous efforts are taken for improvising our services and reducing the complaints which includes but is not limited to Statistical Evaluation of the following:
- Patient Feedback
- Clinician / Hospital feedback
- Complaint Analysis
- Analysis of Turn Around Time
- Pre analytical errors identified during Sample Reception
- Test Order Accuracy/ Pre analytical errors identified during sample registration/ accessioning
- Non- Reportable Cases
Based on the statistical evaluation of the above, improvements plans are drawn for the next term/ year and efforts are made to achieve the same.