How LIMS Helps Diagnostic Labs Achieve and Keep NABL Accreditation
How LIMS Help Diagnostic Labs Achieve and Maintain NABL Accreditation
In the current scenario, the healthcare industry is more focused on accuracy and efficiency. Clinical laboratories play an important role in the healthcare delivery network and NABL (National Accreditation Board for Testing and Calibration Laboratories) accreditation is an indicator of eminence. However, labs operating with NABL guidelines face a critical challenge with paper documentation of test results and laboratory processes. Modern laboratory information management system (LIMS) can help achieve complete NABL accreditation and compliance.
Simplifying Sample Traceability to Aid Chain of Custody Audits
To secure NABL accreditation requires seamless tracking of all test samples at every step of the diagnostic process. Tracking specimens on paper between sample collection, centrifuging, aliquoting, pre-analytical testing, analytical testing and storage is highly error-prone and could lead to cross-contamination and mix-up of test samples. A LIMS automates sample accessioning by logging barcoded or QR-coded specimen information at the point of sample receipt in the laboratory. specimen information at the point of sample receipt in the laboratory. This ensures that there are no mix-ups of samples during the testing process and guarantees complete traceability of specimen at any point during the diagnostic workflow. LIMS-based chain of custody documentation can be instrumental in facilitating hassle-free NABL auditing of the testing laboratory.
Facilitating Data Integrity and Eliminating Manual Entry of Results
The single most crucial requirement for NABL compliant diagnostic laboratories is about the documentation of data integrity and traceability around the diagnostic workflow. The regulatory body requires all clinical laboratories to provide a complete audit trail of all the test results with time-stamped approvals from the concerned pathologists and lab technicians. The LIMS platform ensures data integrity by restricting unauthorised access to test results and clinical data. The system allows bi-directional data exchange with external laboratory instruments, thereby eliminating the need for manual data entry and transcription of test results.
Automating Quality Control and Result Review
NABL accreditation requires the diagnostic laboratory to adhere to the highest standards of quality control (QC) and participate in external quality assessment schemes (EQAS). A LIMS plays a pivotal role in automating the quality control processes at laboratories and ensuring complete compliance with NABL norms. The system generates Levey-Jennings control charts and applies Westgard rules for internal quality control review. The LIMS system restricts report generation in case of any out-of-control situations with regard to analytical QC rules or daily acceptable mean deviation limits. This ensures that no faulty or erroneous test results reach the hands of the clinicians and patients.
Compliance Support with Regards to Equipment, Inventory, and Staff
NABL accreditation also requires laboratories to ensure that all laboratory equipment, reagents and staff members are fully compatible with the quality objectives. LIMS-based laboratories maintain an inventory of all reagents including their lot numbers and expiry dates which prevents the use of substandard reagents in the testing process. The LIMS platform also maintains staff competencies and tracks training records to ensure that only certified lab technicians are allowed to operate the laboratory instruments and assays.
Auditing Support to Facilitate NABL Accreditation and Surveys
Securing the NABL accreditation is one thing, but sustaining the accreditation requires laboratories to prepare for surprise survey visits by the accreditation bodies. LIMS platforms help laboratories prepare for these surprise visits by collating all quality control data and generating reports on management reviews and statistical analysis of the test results. Using a LIMS platform, laboratory managers can quickly pull out calibration and proficiency testing data for laboratory instruments and provide patient test results upon the request of NABL auditors.
Conclusion
NABL accreditation requires laboratories to ensure absolute compliance with quality requirements at all stages of the testing process. The process of manually ensuring compliance can be tedious and prone to errors. However, LIMS platforms can automate the compliance procedures within laboratory processes and facilitate hassle-free NABL accreditation and compliance. By ensuring complete data integrity, quality control compliance, sample traceability and audit trails, the LIMS system can ensure that diagnostic laboratories function at the peak of performance while complying with NABL regulations.
