Developed by the International Organization for Standardization (ISO), ISO 15189 is an international standard that specifies the requirements for quality and competence in medical laboratories, including laboratory management, personnel qualifications, equipment, and quality of analytical procedures.
On the other hand, ISO 20658 is a specification that focuses on the collection and transport of samples to a laboratory for testing. These activities are collectively known as pre-analytical processes, which also include receipt and handling of samples.
Essentially, these documents provide the requirements for all activities related to the collection, management and transport of samples to ensure the quality of laboratory test results and to achieve better health outcomes for patients.
ISO 15189 and ISO 20658 criteria is a demanding process that requires laboratories to adhere to strict standards to ensure regulatory compliance. Without a solution in place, the consequences for laboratories can be significant, resulting in unreliable test results, limited market opportunities, increased costs and legal repercussions.
Those looking to improve their processes in order to maintain ISO certification have as their main pains:
Internal and external audits and assessments, as these can be rigorous and time-consuming, requiring compliance with standards to be demonstrated and corrective action to be taken where necessary;
Paper-based systems or outdated electronic document management methods, which can lead to difficulties in maintaining accurate records and ensuring traceability. Manual processes are often tedious and prone to errors, such as misplacing or losing important documents.
Indexor offers the functions needed to achieve and maintain ISO 15189 and ISO 20658 certifications:
Sample traceability ensures that the journey of each sample is documented, with automated recording of sample placement within an iRack, the ability to search for specific samples and access to the sample’s history.
Sample workflow automates pre-lab processes and enhances efficiency by sorting samples and quickly identifying STAT and urgent samples. Worklists also help by reducing the time needed to sort and route samples for the intended workflow.
Indexor’s connection to the LIS is a key strength that supports compliance by ensuring that the workflow fits into the larger laboratory operation and promotes data consistency.
Sample transport features provide a strong foundation for ISO compliance, such as generating a report upon completion of transport with its conditions such as temperature, shock, and time. The missing sample alert streamlines the process in line with ISO’s emphasis on traceability, as the transfer of the iRack from the iLogger to the Indexor provides instant validation of sample manifesto. In addition, the integration of courier identification enhances traceability in accordance with chain of custody principles.
In essence, it enables laboratories to effectively trace and transport samples throughout the workflow, optimizing pre-lab processes through automated data collection and evidence-based sample management.
