Method and system for patient and biological sample identification and tracking
The present invention provides a device and system for monitoring the accuracy of procedures in the course of the performance of a task, the task comprising at least one procedure to be performed, the device comprising: an input interface for receiving input data relating to the procedures; a data store for storing data relating to the procedures; a processor for: comparing the input data with the stored data; and generating a comparison result indicating the result of that comparison; and an output interface for outputting the comparison result.
1. A method of tracing one or more biological samples at any location in an assisted reproductive technology (ART) laboratory environment in the course of performance of a task, the method comprising the steps of:
locating an RF transceiving device proximate a biological sample container wherein the RF transceiving device is encased in polymer that is resistant to a range of laboratory conditions including one or more of a cryo-environment and gamma irradiation;
interrogating the RF transceiving device with a portable reader device for identification signals unique to the biological sample; and
tracking the location of the one or more biological samples based on the interrogation of the RF transceiving device and indexing the location in a centralised database;
wherein the method is periodically applied to one or more biological samples during (i) a configuration process and (ii) a supervision process,
the configuration process involving creating and editing labels for the one or more biological samples associated with a patient, creating label groups corresponding to ART treatment cycles, assigning labels to a development timeline in each treatment cycle, specifying critical labels and specifying critical activities to be undertaken in relation to the one or more samples;
the supervising process involving management of an active task list for the patient including progress of the biological sample against the development timeline, management of consumables and inventories for lot numbers of consumables used in the treatment cycles, and generating reports.
2. The method as claimed in claim 1 further comprising the steps of:
locating further RF transceiving devices corresponding to each of a hierarchy of laboratory apparatus for addressing the location of the biological sample within a laboratory environment.
3. The method as claimed in claim 1 wherein one or a combination of the step of interrogating and the RF transceiving device comprises at least one MEMS device.
4. The method as claimed in claim 1 wherein the RF transceiving device is adapted to transmit in situ environmental conditions of the biological sample in addition to identification signals unique to the biological sample.
5. Apparatus for tracing one or more biological samples at any location in an assisted reproductive technology (ART) laboratory environment in the course of performance of a task, comprising:
an RF transceiving device adapted for location proximate a biological sample container wherein the RF transceiving device is encased in polymer that is resistant to a range of laboratory conditions including one or more of a cryo-environment and gamma irradiation;
interrogation means comprising at least a portable reader device for interrogating the RF transceiving device for identification signals unique to the one or more biological samples; and
tracking the location of the one or more biological samples based on the interrogation of the RF transceiving device and indexing the location in a centralised database;
wherein the interrogation device periodically interrogates the RF transceiving device and periodically tracks the location of the one or more biological samples during (i) a configuration process and (ii) a supervision process,
the configuration process involving creating and editing labels for the one or more biological samples associated with a patient, creating label groups corresponding to ART treatment cycles, assigning labels to a development timeline in each treatment cycle, specifying critical labels and specifying critical activities to be undertaken in relation to the one or more samples;
the supervising process involving management of an active task list for the patient including progress of the biological sample against the development timeline, management of consumables and inventories for lot numbers of consumables used in the treatment cycles, and generating reports.
6. Apparatus as claimed in claim 5 wherein one or a combination of the RF transceiving device and the interrogation means comprises a MEMS construction.
7. The method as claimed in claim 1 wherein the biological samples are chosen from one or more of sperm, embryo, eggs and gametes.
8. The method as claimed in claim 4 wherein the biological samples are chosen from one or more of sperm, embryo, eggs and gametes.
9. The method as claimed in claim 1 wherein the method further comprises the steps of:
capturing data or information about one or a combination of;
an individual operator handling the biological samples, including the qualifications of the operator,
identity of a patient corresponding to the biological samples,
laboratory process steps, including timing of process steps,
the environment and environmental parameters including temperature, humidity, CO 2 levels during the process steps,
the operator's performance of the process steps,
the location of biological samples,
the lot numbers, batch numbers, expiry dates and other information about the materials and consumables used during the process steps,
the equipment used, including their service, calibration and operational status, performing a comparison of the captured data or information with reference data;
generating one or a combination of at least one confirmation, warning or alarm depending on the outcome of the comparison, and;
capturing the generated confirmations, warnings or alarms to a separate record to be used for quality assurance and quality control auditing and training.