Clinical Sample Acceptance Policy

1.0 PURPOSE 

The purpose of this document is to define the minimum acceptance criteria for clinical samples submitted to AGRF. It provides clear guidance to ensure that all samples are correctly identified, appropriately handled, and meet quality requirements for reliable downstream processing. It also outlines procedures for addressing non-conforming or irreplaceable samples to maintain traceability, sample integrity, and compliance with clinical and laboratory best practices. 

2.0 SCOPE 

This document applies to all clinical samples submitted to AGRF for processing and outlines the standards required for sample identification, integrity, documentation, and quality. It is intended for both external clients and AGRF staff involved in sample receipt, handling, and processing. These standards ensure consistent acceptance criteria across all AGRF sites. Guidance for managing non-conforming and irreplaceable samples is also provided. 

3.0 REFERENCES 

Monash Health Pathology: Labelling Requirements Handbook 

NSW Health Pathology: sample acceptance guidelines 

NPAAC Guidelines: Requirements for medical pathology services (Third Edition 2018) 

4.0 DEFINITIONS 

Identifiable Sample 
A sample labelled with patient-specific information such as full name, date of birth, and/or medical record number (MRN), or unit record number (UR).  

De-identified Sample 
A sample labelled with non-identifying unique codes (e.g., Sample ID and Tube ID) and no personal health information.  

Unique Identifier 
A distinct label or code (e.g., Sample ID, Tube ID, UR/MRN).  

Irreplaceable Sample 
A specimen that cannot be recollected due to its invasive nature, one-time availability, or where recollection would compromise patient safety or research integrity.  

Non-conformance 
Any deviation from the sample acceptance standards, including labelling errors, contamination, insufficient volume, or expired samples. 

Sample Submission Receipt 
The form completed and submitted with samples to AGRF, detailing project information, identifiers, service requested, and any specific handling instructions. 

Primary Sample 
The original biological material collected from a subject or patient (e.g., blood, saliva, tissue), prior to any processing or extraction. 

Processing 
All steps involved in handling the sample post-receipt, including extraction, purification, analysis, and data generation. 

Contamination 
Unintended introduction of substances (e.g., other DNA, chemicals, microorganisms) that may compromise sample integrity. 

Collection Date 
The date the primary sample was collected.  

5.0 SAFETY PRECAUTIONS 

5.1 General Hazards 

Type: PC Use 
Hazards: Eye/Muscular Strain 
Controls: Ensure workstation is set up comfortably, take appropriate breaks for extended use 
Ensure maintenance checks and electrical testing is current on equipment 
Risk Reference: RA-401 

6.0 PROCEDURE  

6.1 Sample Identification: 
Labelling: Each sample must be labelled clearly and correctly with a unique identifier.  
Identifiable samples: Each sample must be labelled clearly and correctly with at least 2 identifiers: Patient name (first AND last), DOB or sending facilities patient UR/MRN number. A collection date for primary samples is also required although it does not qualify as a patient identifier. Three identifiers are recommended. 
De-identified samples: Each sample must be labelled clearly and correctly with 2 unique identifiers (e.g Sample ID and Tube ID). A collection date for primary samples is also required although it does not qualify as a patient identifier.  
Accuracy: Labels must be clear and legible to avoid any misidentification.
Consistency: The information on the sample must match the accompanying AGRF submission documentation.  
Non-conformance: The client will be contacted for any non-conformance and an incident report will be raised. Any non-irreplaceable samples not meeting the appropriate sample identification requirements will be destroyed and will require recollection. The samples cannot be returned to the client. The samples cannot be re-identified.    

6.2 Sample Integrity:  
Collection: Samples should be collected using appropriate techniques to avoid contamination as per AGRF recommendations for the given service, contained within appropriate service guides.  
Storage: Samples must be stored at the correct temperature (e.g., refrigerated, frozen) to preserve their integrity as per AGRF recommendations for the given service.  
Transport: Samples should be transported in a timely manner and under conditions that prevent degradation as per AGRF recommendations for the given service.  

6.3 Documentation:  
Clinical Information: Relevant clinical information must be provided to AGRF for the given service e.g. biological sex for contamination checks.
AGRF Submission and Agreements: The AGRF Sample Submission Receipt must accompany each submission, detailing the service required and any special instructions.  

6.4 Rejection Criteria:  
Improper Labelling: Samples that are not labelled correctly or have missing information will require consultation with the client prior to processing.  
Contamination: Samples that are visibly contaminated or compromised will be rejected, following consultation with the client.  
Insufficient Volume: Samples that do not have enough volume for the required services will be rejected, following consultation with the client.
Expired Samples: Samples that are not received within the acceptable time for processing may be rejected, following consultation with the client.    

After discussion with the client, any samples which meet the rejection criteria will be disposed of and the client will be notified using LIMS. Samples cannot be relabelled or returned to the client.  

7.0 Irreplaceable Samples  

Definition: Samples that cannot be recollected due to the invasive nature of collection, or samples which if recollected will not reflect the originally collected sample, such as time point experiments. Irreplaceable samples may also include samples where recollection may compromise patient safety. Examples of irreplaceable samples include but are not limited to; Bone marrow specimens, surgical specimens (e.g. tissue), Cerebrospinal fluid (CSF), or nucleic acids derived from any of the above.  
Processing: Irreplaceable samples that do not meet acceptance criteria may be processed at the discretion of the node manager. Sample collector/client will need to confirm the identification of the sample and sign an “acceptance of responsibility” declaration.    

8.0 Quality Control:  

  • Regular Audits: Conduct regular audits to ensure compliance with sample acceptance standards.  

  • Training: Ensure all personnel involved in sample collection and handling are trained.  

  • Documentation: Maintain detailed records of all samples received, including any issues encountered and actions taken.