The Role of Technology in Healthcare Accreditation — LIS, LIMS, and Digital Tools
Technology is an increasingly important enabler of NABL and NABH accreditation. Laboratory Information Systems (LIS), LIMS, and other digital tools can significantly reduce the burden of documentation and monitoring.
Technology is an increasingly important enabler of NABL and NABH accreditation. Laboratory Information Systems (LIS), LIMS, and other digital tools can significantly reduce the burden of documentation and monitoring.
ISO 15189:2022 specifically addresses the management of laboratory information systems (LIS) as part of the quality management system. For labs and hospitals seeking accreditation, understanding the technology requirements is important.
LIS Requirements Under ISO 15189:2022
- Validation of LIS before use (including after any updates)
- Access control (user authentication and role-based access)
- Audit trails for changes to patient data
- Backup and disaster recovery procedures
- Data integrity assurance
- Interface validation between LIS and analysers
How a Good LIS Helps Accreditation
- Automatic result flagging for delta check and critical values
- IQC data collection and Levey-Jennings chart generation
- TAT monitoring and reporting
- Rejection log management
- Traceability of result release and modifications
What If You Don’t Have a LIS?
NABL accreditation does not require a LIS. Many smaller labs operate successfully with manual or semi-automated systems. However, a well-implemented LIS makes the accreditation journey significantly easier and the ongoing compliance much more manageable.
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