All images used for diagnostic purposes must be stored on a secured device in a secure location.
All storage devices (including database servers and backup devices) used for storing and archiving images and related case information, must also be kept in a secure location.
There must be an efficient and reliable method for storing and retrieving images (including from online and archive file systems).
Data integrity must be maintained, so the storage device must ensure that the data is stored reliably, and there is no data loss or corruption if the storage device fails. An appropriate archive and backup process should also be put in place to protect image data and associated metadata according to regulated preservation guidelines and durations.
The storage device should be able to store as fast as the scanner can transmit the image file. If the storage system is connected to an LIS, then the storage device should also be able to store as fast as the LIS can transmit data. Archived data must be stored on robust storage devices and not a portable media format (such as laptop, smartphone, tablet, or USB stick).
The case data (including digital slide images, patient and clinical information) can only be modified with appropriate tracking.
A secure transmission protocol should be used for image and data transfer such as Hypertext Transfer Protocol (HTTP) across networks. This is a protocol used to request and transmit files, especially webpages and webpage components, over the Internet or other computer network. (REF 24)
The stored digital slide image must be associated with the machine-readable identifier.
Storage must be able to associate the scanned machine-readable identifier to the scanned image, and depending on the communication with the LIS the patient metadata may also be linked to the record.
If the digital microscopy system is integrated with a LIS, the minimum information to be stored in the digital microscopy system storage for each case includes:
- Patient identifiers (minimum of two) as per NPAAC requirements in Australia,
- Patient data,
- Case information including accession number, block number, stain types,
- Appropriate timestamps of transmission records,
- Tracking of details for audit functionality and pathologist comments.
Each scanned image should contain a record of the following information at a minimum:
- file dimensions;
- colour depth;
- image resolution;
- creation date and time.
Each image captured for a given identifier should be stored and be able to be viewed or deleted by the user, as required, with appropriate tracking.
The stored image and related case data must be available for the minimum retention time.
When WSI are used for diagnostic purposes, the storage of the WSI and associated diagnostic material must satisfy the existing retention times for glass slides; for Australia, as stated in the NPAAC publication Requirements for The Retention of Laboratory Records and Diagnostic Material.
Glass slides must also be kept for the minimum retention time; for Australia, as stated in the NPAAC publication Requirements for The Retention of Laboratory Records and Diagnostic Material.