History logging for samples of biological material

Patent metadata

Field	Value
Publication number	US-11977088-B2
Application number	US-201716313704-A
Country	US
Kind code	B2
Filing date	Jun 16, 2017
Priority date	Jun 27, 2016
Publication date	May 7, 2024
Grant date	May 7, 2024

Abstract

A method of reducing quality problems associated with patient sample collection and delivery is provided. It is possible that the method can provide a chain of custody process to better track a sample from the initial point of sample collection to the final point of sample testing. Such a method can also include providing an alert to indicate a potential problem with the quality of the diagnostic test result when a measured parameter exceeds a threshold.

First claim

The invention claimed is:

1. A machine comprising:
a) a sample transport container, the sample transport container adapted to store and enable transport of a plurality of sample holders for samples of biological materials collected from patients;
b) a set of one or more environment sensors adapted to take measurements of one or more characteristics of an environment of the sample transport container;
c) a set of one or more history loggers, wherein each history logger from the set of history loggers is programmed to receive transit data for those samples of biological material; and
d) a sample manager located at a testing location and programmed to:
i) for each sample of biological material transported in the sample transport container, make history logging information for that sample of biological material available at the testing location, wherein the history logging information is taken from a set of history logs, each of which:
1) is associated with a single sample of biological material with a unique identifier for that sample of biological material; and
2) comprises:
a) a set of measurements of one or more characteristics of the environment of the sample transport container while the associated sample of biological material was in transit; and
b) a transit initiation timestamp, wherein the transit initiation timestamp is when the associated sample of biological material was placed into the sample transport container for transit;

and

ii) provide, based on a level of conformity or non-conformity of a sample of biological material with a set of requirements for a medical diagnostic test, at least one user instruction;

wherein:
A) the set of one or more environment sensors adapted to take measurements of one or more characteristics of the environment of the sample transport container comprises one or more temperature sensors adapted to take temperature measurements of the environment of the sample transport container;
B) the machine comprises a central monitor programmed to maintain the set of history logs by performing acts comprising:
I) receiving transit data from history loggers for samples of biological material;
II) storing the transit data for samples of biological material in database records associated with the unique identifiers of each of the samples of biological material to which the transit data relates; and

C) the central monitor is programmed to determine the level of conformity or non-conformity of the sample of biological material with the set of requirements for the medical diagnostic test by performing a set of acts comprising:
I) using the unique identifier of the sample of biological material, retrieving data indicating that the medical diagnostic test is to be performed with that sample of biological material;
II) performing a set of comparisons comprising:
a) comparing temperature data from the set of one or more temperature sensors with a temperature threshold associated with the medical diagnostic test;
b) comparing how long the sample of biological material had been in transit with a transit time threshold associated with the medical diagnostic test; and
c) comparing a time delay between when the sample of biological material was collected and when it was placed in transit with a collection delay threshold for the medical diagnostic test;
and

III) based on the set of comparisons, determining the level of conformity or non-conformity from a plurality of potential levels of non-conformity, wherein the plurality of potential levels of non-conformity comprises at least two levels in which the sample of biological material does not conform to the set of requirements for the medical diagnostic test.

2. The machine of claim 1 , wherein:
a) the set of one or more environment sensors adapted to take measurements of one or more characteristics of the environment of the sample transport container comprise one or more temperature sensors adapted to take temperature measurements of the environment of the sample transport container;
b) the history logging information the sample manager located at the testing location is programmed to make available at the testing location for a sample of biological material comprises:
i) how many individuals have handled the sample of biological material while in transit;
ii) duration of time the sample of biological material is in transit; and
iii) temperature the sample of biological material has been exposed to while in transit.

3. The machine of claim 1 , wherein the at least one user instruction is selected from a group consisting of:
a) an instruction to evaluate a result of the medical diagnostic test using a modified evaluation parameter, wherein the modified evaluation parameter is a parameter to evaluate a result of the medical diagnostic test instead of a default evaluation parameter, wherein the modified evaluation parameter is a first level of test product for indicating a positive result which is lower than a default level of test product for indicating a positive result; and
b) an instruction to rerun the medical diagnostic test with the sample of biological material one or more times.

4. The machine of claim 1 , wherein:
a) the machine comprises a central monitor programmed to maintain the set of history logs by performing acts comprising incorporating data received from the history loggers into database records associated with unique identifiers of samples of biological material to which that data relates;
b) the set of one or more history loggers comprises:
i) a first sample manager located at a collection point for samples of biological material; and
ii) a second sample manager located at a preparation site for samples of biological material;

c) the first sample manager is programmed to send to the central monitor, for each sample of biological material collected at the collection point where the first sample manager is located:
i) a timestamp reflecting when that sample of biological material was collected;
ii) a unique identifier for that sample of biological material;

d) the second sample manager is programmed to, for each sample of biological material received at the preparation site where the second sample manager is located:
i) retrieve, from the central monitor using the unique identifier for that sample of biological material, a set of preparation activities to perform for that sample of biological material; and
ii) present instructions to perform the set of preparation activities for that sample of biological material.

5. The machine of claim 4 , wherein:
a) each history logger from the set of one or more history loggers is programmed to:
i) require a user of that history logger to authenticate his or her identity before that history logger could:
1) receive information about samples of biological material taken from patients; and
2) communicate information about samples of biological material taken from patients with either the central monitor or other history loggers;

ii) inform the central monitor of the authenticated identity of the user of that history logger and the unique identifiers of samples of biological material handled by the user of that history logger; and

b) the central monitor is programmed to, based on receiving a message that a sample of biological material has arrived at the testing location, using the unique identifier for the sample of biological material, retrieve data indicating the authenticated identities of all users of history loggers who had handled the sample of biological material.

6. The machine of claim 1 , wherein the unique identifiers for the samples of biological material in the history logs comprise, for each sample of biological material transported in the sample transport container, at least one of:
a) an i

Assignees

• Beckman Coulter Inc

Inventors

• Menhardt Wido
• Hanson Matthew
• Camisa Anthony

Classifications

• G01N35/00613 Primary

  Quality control · CPC title

• B01L9/06

  Test-tube stands; Test-tube holders · CPC title

• G01N35/00712

  Automatic status testing, e.g. at start-up or periodic · CPC title

• G01N35/00871 Primary

  Communications between instruments or with remote terminals · CPC title

• G16H10/40

  for data related to laboratory analysis, e.g. patient specimen analysis · CPC title