US-12626791-B2 - Sample tracking via sample tracking chains, systems and methods

US12626791B2US 12626791 B2US12626791 B2US 12626791B2US-12626791-B2

Abstract

Systems and methods for tracking samples via sample tracking chains are presented. Sample tracking chains represent digital data structures instantiated according to intrinsic properties of a sample. Each link in the chain is a block of data representing an observed intrinsic state of the sample and is linked at least to a previous block representing a previous state. The sample tracking chain and blocks can be indexed for later retrieval by the intrinsic properties of the corresponding sample's state. The sample tracking chain can take the form of a blockchain possibly stored as part of a private or public distributed ledger. Disclosed sample tracking chains provide a full life cycle audit trail for sample processing.

Inventors

Nicholas James Witchey
Patrick Soon-Shiong

Assignees

NANT HOLDINGS IP, LLC

Dates

Publication Date: 20260512
Application Date: 20240328

Claims (19)

1 . A computer-based patient sample audit trail system, the system comprising: at least one non-transitory computer readable memory storing software instructions and a patient sample audit trail comprising a sample tracking chain; and at least one processor coupled with the at least one memory and that executes the following operations upon execution of the software instructions: obtaining a digital image of at least one assay of at least one patient sample by applying multiplex fluorescent immunohistochemistry (IHC) enabled characterization to at least one slide having the at least one patient sample, and capturing the digital image using an automated scanning system, the at least one assay representing a snap shot in time for a patient; generating intrinsic properties of the at least one assay from digital descriptors obtained from executing one or more implementations of at least one image processing algorithm on the digital image; retrieving a previous patient-related state object related to the at least one assay from the sample tracking chain; instantiating a current state object in the at least one non-transitory computer readable memory as a function of the intrinsic properties and the previous patient-related state object; updating the sample audit trail in the at least one non-transitory computer readable memory by linking the current state object to the previous patient-related state object in the sample tracking chain; and enabling validation of a target patient sample by comparing intrinsic properties of the target patient sample to intrinsic properties stored in the sample tracking chain, wherein the previous patient-related state object and the current state object comprise an immunoassay workflow.
2 . The system of claim 1 , wherein the previous patient-related state object represents a previous snap shot in time relative to the snap shot in time.
3 . The system of claim 2 , wherein the previous snap shot in time is associated with the at least one assay.
4 . The system of claim 1 , wherein the sample tracking chain comprises a patient-related sample life cycle chain.
5 . The system of claim 4 , wherein the patient-related sample life cycle chain comprises a whole life cycle chain.
6 . The system of claim 1 , wherein the sample tracking chain comprises a sample-specific audit trail.
7 . The system of claim 1 , wherein the sample tracking chain comprises a blockchain-based audit trail.
8 . The system of claim 1 , wherein the sample tracking chain complies with IEC 62304 audit trail requirements.
9 . The system of claim 1 , wherein the sample tracking chain complies with 21 CFR part 11 requirements.
10 . The system of claim 1 , wherein the sample tracking chain comprises HIPPA compliant data related to the at least one patient sample.
11 . The system of claim 1 , wherein the sample tracking chain comprises a patient's personal tracking chain.
12 . The system of claim 11 , wherein the patient's personal tracking chain comprises a side chain.
13 . The system of claim 1 , wherein the sample tracking chain comprises a blockchain.
14 . The system of claim 13 , wherein the blockchain comprises at least one of the following: a public distributed blockchain ledger, a private blockchain, a semi-private blockchain, and a healthcare historical blockchain.
15 . The system of claim 1 , wherein the current state object comprises a pointer to external data relative to the sample tracking chain.
16 . The system of claim 15 , wherein the external data comprises information related to the at least one assay.
17 . The system of claim 1 , wherein the intrinsic properties relate to a color from the at least one assay.
18 . A computer implemented method for processing a patient sample audit trail, the method comprising: obtaining a digital image of at least one assay of at least one patient sample by applying multiplex fluorescent immunohistochemistry (IHC) enabled characterization to at least one slide having the at least one patient sample, and capturing the digital image using an automated scanning system, the at least one assay representing a snap shot in time for a patient; generating intrinsic properties of the at least one assay from digital descriptors obtained from executing one or more implementations of at least one image processing algorithm on the digital image; retrieving a previous patient-related state object related to the at least one assay from a sample tracking chain of a patient sample audit trails stored in at least one non-transitory computer readable memory; instantiating a current state object in the at least one non-transitory computer readable memory as a function of the intrinsic properties and the previous patient-related state object; updating the sample audit trail in the at least one non-transitory computer readable memory by linking the current state object to the previous patient-related state object in the sample tracking chain; and enabling validation of a target patient sample by comparing intrinsic properties of the target patient sample to intrinsic properties stored in the sample tracking chain, wherein the previous patient-related state object and the current state object comprise an immunoassay workflow.
19 . A computer program product for processing a patient sample audit trail, the computer program product comprising a non-transitory computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to: obtain a digital image of at least one assay of at least one patient sample by applying multiplex fluorescent immunohistochemistry (IHC) enabled characterization to at least one slide having the at least one patient sample, and capturing the digital image using an automated scanning system, the at least one assay representing a snap shot in time for a patient; generate intrinsic properties of the at least one assay from digital descriptors obtained from executing one or more implementations of at least one image processing algorithm on the digital image; retrieve a previous patient-related state object related to the at least one assay from a sample tracking chain of a patient sample audit trails stored in at least one non-transitory computer readable memory; instantiate a current state object in the at least one non-transitory computer readable memory as a function of the intrinsic properties and the previous patient-related state object; update the sample audit trail in the at least one non-transitory computer readable memory by linking the current state object to the previous patient-related state object in the sample tracking chain; and enable validation of a target patient sample by comparing intrinsic properties of the target patient sample to intrinsic properties stored in the sample tracking chain, wherein the previous patient-related state object and the current state object comprise an immunoassay workflow.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 17/171,584, filed on 9 Feb. 2021, which is a continuation of U.S. application Ser. No. 15/708,837, filed on 19 Sep. 2017, which claims priority to U.S. Provisional Application No. 62/396,986, filed on 20 Sep. 2016. The contents of each application recited above are incorporated by reference herein in their entirety. FIELD OF THE INVENTION The field of the invention is digital state tracking technologies. BACKGROUND The background description includes information that may be useful in understanding the systems and methods described herein. It is not an admission that any of the information provided herein is prior art, or that any publication specifically or implicitly referenced is prior art. Many medical treatments, especially oncological treatments require analysis of one or more biological samples taken from a patient. Typically such samples are extrinsically labeled for tracking or identification purposes. For example, a sample in a container might have a bar code or patient identifier label affixed to its container As the samples are processed through a workflow, a technician can scan such labels to ensure the sample properly works its way through the analysis workflow or its complete life cycle. Unfortunately, even in today's computer driven environments, biological sample tracking is fraught with issues; many of which arise due to the nature of the computing environments. One issue is that labels are generated extrinsically, which creates an opportunity for a worker to place a wrong label on the sample either accidently or due to improper data entry. Another issue is that the data generated through the analysis is merely stored in a database only accessible via the extrinsic information (e.g., bar code, label, patient's name, etc.) without having a built-in mechanism to validate that the retrieved data is, in fact, associated with the target biological sample. Consider the following efforts applied to tracking biological samples. U.S. Pat. No. 8,431,078 to Schutze et al. titled “Sample Holder for a Reception Device Receiving Biological Objects and Microscope System Designed to Operate Using One Such Sample Holder”, filed internationally Nov. 20, 2003, describes a system that attempts to ensure unambiguous identification of samples by a microdissection device. The Schutze system requires that a sample holder have a coding that can be used to present selection functions to a user on a display. While useful for controlling a microdissection device in a manner appropriate for a sample, the disclosed system fails to provide insight into tracking biological samples through an entire life cycle of analysis and into creation of an intrinsic audit trail. Further, if the coding of the sample holder is mislabeled, then incorrect functions could be presented to a technician. Further progress is made by U.S. Pat. No. 8,676,509 to De La Torre-Bueno titled “System for Tracking Biological Samples” filed Nov. 13, 2002. De La Torre-Bueno seeks to provide real-time tracking of samples from collection through to storage. Samples are associated with unique bar code identifiers that link to processing steps at various workstations. Such an approach aids in reducing possible processing errors with respect to managing slides. However, the system still requires significant interaction on the part of humans to tag the samples in the first place. Again, if at any time the bar code is incorrectly used, the slides could be mismanaged. Still further, the bar code tags could degrade over time reducing their efficacy for use over long term studies. Yet another example includes U.S. Pat. No. 9,354,147 to Lefebvre “Automated System and Method of Processing Biological Specimens” filed May 28, 2014. Lefebvre focuses on an automated system that transports specimen slides to and from an imaging unit. In addition, Lefebvre indicates that the slides, as well as other items in the system, can be identified with machine understandable codes (e.g., RFID, barcodes, etc.). Again, such systems are considered useful as tracking system elements. However, such tags or codes can be damaged over time rendering them less useful or the codes; and yet again, could be mishandled. Still further effort has been directed to binding patient information with sample identifier information at a high level. For example, U.S. patent application publication U.S. 2008/0235055 to Mattingly et al. titled “Laboratory Instrumentation Information Management and Control Network”, filed Jun. 13, 2007, discusses forming a harmonized specimen identifier from a case identifier of a patient and a specimen identifier. The harmonized specimen identifier represents a combination of identifiers arranged in a defined format, possibly a hierarchal format, where the various identifiers aid in tracking a specimen at different points in a workflow. However, Mattingly's harmonized sp