Notice
- Important: This guidance is under active development by NHS England and content may be added or updated on a regular basis.
- This Implementation Guide is currently in Draft and SHOULD NOT be used for development or active implementation without express direction from the NHS England Genomics Unit.
Black Box
Currently, there is variation across England in the functional capability available within pathology and genomics LIMS implementations. As a result, there is a potential that any of these laboratories may not be able to meet the interoperability messaging requirements from a genomic central broker creating a black box scenario where the test or sample if received by the lab, will not have an update on current status until the test or sample arrives at the next organisational boundary.
The potential black box scenarios include:
- Requester is the Black Box: In this scenario, if the requester is the black box, the first update will be created when the sample is received. The requester is completing the test order on paper and is sending the request and sample to the GLH. The GLH will provide the update of test request received/sample received.
- Black Box between requester and location where sample is being collected from: For e.g., a GP places a genomic test request to the GLH, and the sample is to be collected at the hospital. In this scenario, the hospital (location) may be a black box and unable to provide sample updates. In this scenario, the GLH is aware of the test request and will be awaiting the sample. Only when the sample arrives at the GLH and is aligned with the test request, an update of the sample received will be provided.
- Home Lab is the Black Box: the GLH is unable to provide a test request or sample status update to the requester. This may be a low possibility however, in the event the GLH is the Black Box, the requester will only receive an update when the final report has been issued.
- Black Box between requester, specialist lab and home lab: E.g., oncologist refers the patient for genomic testing and the sample is collected and the specialist centre for the test. If the specialist lab is the black box, and is unable to indicate that the test request/sample has been received, the home lab GLH, may not be notified of the status of the test request and sample until a final report has been received by the requester
A programme board decision is required to understand how black box scenarios should be dealt with post Alpha phase. A further decision is required to confirm if black boxes should exist or can be mitigated through access provided at the GLH level to the lab team to enable entry of electronic test requests and the management of sample and test status updates within the central portal.