Sample Retention Policy

1. Purpose

This policy outlines the principles and guidelines for the retention of primary source material (non-extracted), extracted nucleic acid and processed nucleic acid across AGRF services. 

2. Scope 

This policy applies to all AGRF clients and staff with retention of client material including raw, extracted and processed nucleic acid. All clinical (ISO15189) nucleic acids and primary source materials will be retained according to the National Pathology Accreditation Advisory Council (NPAAC) guidelines. Samples which are processed under an ISO17025 accredited or non-accredited service or an exemption request by a client are excluded from the NPAAC guidelines. 

3. References 

National Pathology Accreditation Advisory Council (NPAAC) guidelines ninth edition 2022 - Tier 3B document: Requirements for the retention of laboratory records and diagnostic material (Ninth Edition 2022)  

4. Definitions 

  • Nucleic acid: DNA or RNA which has been extracted from a biological source either by AGRF or the client 

  • Primary source material: Primary biological material supplied to AGRF for the purposes of nucleic acid extraction and downstream processing 

  • Processed Nucleic acid: Nucleic acid which has been processed using an AGRF service 

5. Service Retention Periods

Service-Specific Retention Periods unless client requests sample returns: 

  • Samples submitted under an ISO15189 service: 

  • Primary source material to be discarded two weeks after data has been delivered to the client as per Table 1 of NPAAC guidelines ninth edition 2022, unless client requests samples to be returned or retention extended. 

  • Nucleic acids including processed nucleic acids to be discarded three months after data has been delivered to client as per Table 6, section 6.6 of NPAAC guidelines ninth edition 2022, unless client requests samples to be returned or retention extended. 

  • Samples submitted under an ISO17125 or non-accredited service: 

  • Sanger to be disposed of two weeks after data has been delivered to the client, unless client requests samples to be returned or retention extended. 

  • All other services and sections to be disposed of one month after data has been delivered to the client, except for AGRF extraction in which all material is exhausted as part of the service or on-sent to a downstream AGRF service. 

6. Notice to Clients 

All discards are to use AGRF LIMS to email notify clients when samples are to be discarded and when samples are discarded. Clients will be provided with 7 days to respond to AGRF to confirm if samples are to be returned or discarded. A summary of the retention will be included as part of the AGRF terms and conditions. 

7. Compliance 

Non-compliance with this policy may result in disciplinary action, up to and including termination of employment or contracts. All employees and clients are expected to adhere to this policy and report any concerns or violations.