For sample management, the ramifications of noncompliance with industry norms are significant, risking patient health and organizational credibility.
The need for proper tracking of sample information – location, status, properties, expiration, and activities – is not new. Today, the number of samples in any laboratory is in the hundreds or thousands. These samples are stored in different containers and various locations. Proper and accurate tracking at all stages is imperative for testing accuracy, study validity, and patient safety.
Recently the Global Bioanalysis Consortium (GBC) Harmonization Team released its recommendations for best practices for lab quality control in sample management. The report emphasizes that part of the challenge in lab quality assurance is due to the lack of regulations among health authorities regarding sample management.
The consortium’s guidelines cover the life span of samples used in clinical and non-clinical studies. Further, the guidelines should prevent compromising any samples at any stage of analysis.
Ensuring healthcare quality
Below are the five core recommendations:
- Proper sampling procedures should be detailed in either the laboratory manual or protocol. Information in these procedures should include volume of sample to be collected, the anticoagulant, collection and storage containers, light sensitivity and unique identifier labeling process.
- Documentation is necessary for all proper procedures used in processing and subsequent storing of the samples after they are collected at the clinical or non-clinical testing site and during shipment. Such procedures ensure the stability is maintained.
- A clear chain of custody must exist and be maintained for all samples throughout the whole life span of all samples. Chains of custody are usually tracked via paper and/or electronic data systems, including, where available, a Laboratory Information Management System.
- Storage conditions and locations must be defined at the laboratory conducting analysis during pre- and post-analysis stages. Monitoring systems and alerts regarding sample storage temperatures must be traceable. The consortium recommends that standard terminology be established with defined and industry-wide acceptable temperature ranges for “refrigerator,” “freezer,” “ultra-freezer” and “room temperature.” These standards should replace using temperatures.
- When a study is ended, documentation is needed regarding the disposal of any samples.
The World Health Organization recently illustrated the serious ramifications of improper sample collection. The WHO identified seven significant risks due to collection errors:
- Test reporting delays
- The need to re-draw and re-test
- A decrease in customer satisfaction
- Increases in costs
- Inaccurate diagnoses and treatment orders
Systems must offer easy usability for lab staff and provide electronic audit trails and reporting on chain of custody, labeling and the labeling details recommended by the consortium.
Freezerworks provides products and services for laboratories that ensure compliance and accuracy of all sampling labeling and tracking. With a locally hosted software solution, Freezerworks is fully configurable to handle samples using varied storage methods. To learn more about how Freezerworks can assist with your sample management needs, contact us for more information.