# US 11,308,433 B2 · Point-of-care testing system

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- Number: US 11,308,433 B2
- Document ID: US11308433B2
- Status: Granted
- Kind: B2
- Application number: 15/140,547
- Filed: 2016-04-28
- Published: 2016-11-03
- Granted: 2022-04-19
- Earliest claimed: 2015-05-02
- Assignees: Roche Diagnostics Operations, Inc.
- Applicants: Roche Diagnostics Operations, Inc.
- Inventors: Diego Delgrande; Gillian Hall; Alejandro Morcillo Montejo; Stephanie Shufelt
- Web page: https://patentgrep.com/patent/US11308433B2

## CPC

- G06Q 10/0633: Workflow analysis
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 40/63: for local operation
- H04L 63/0823: {using certificates (cryptographic mechanisms or cryptographic arrangements for entity authentication involving certificates H04L9/3263)}
- H04L 63/10: {for controlling access to devices or network resources}
- H04W 4/50: Service provisioning or reconfiguring
- G16H 40/67: for remote operation
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H04L: TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION (arrangements common to telegraphic and telephonic communication H04M)
- H04W: WIRELESS COMMUNICATION NETWORKS (broadcast communication H04H; communication systems using wireless links for non-selective communication, e.g. wireless extensions H04M1/72)

## Abstract

A point of care (POC) testing system and a method for configuration of a POC testing system are disclosed that provide a workflow solution for the configuration management of POC analyzers. In some embodiments, the system and method provide for convenient assisted workflows that enable efficient management of POC analyzer operator certifications.

## Claims

### Claim 1

A method for configuration of a point of care (POC) testing system, the method comprising:
providing one or more POC analyzer(s) for analyzing one or more patient sample(s);
providing one or more operator identifier(s) corresponding to one or more operators of the POC testing system, each operator identifier uniquely identifying the respective operator;
providing a portable computing device to a POC coordinator responsible for maintenance of the one or more POC analyzer(s), wherein the portable computing device is not a POC analyzer;
providing a server for storing one or more system certification(s), each corresponding to one or more POC analyzer(s), wherein the one or more system certification(s) are certifications stored on the server and wherein a certification is indicative of user(s) being authorized to use one or more of the one or more POC analyzer(s) with respect to one or more functions of the one or more of the one or more POC analyzer(s);
communicatively connecting the one or more POC analyzer(s) and the portable computing device with the server via a communication network;
selecting by the POC coordinator one or more system certification(s) via a user interface of the portable computing device;
identifying by the portable computing device one or more operator(s) using one or more operator identifier(s);
receiving by the portable computing device a certification configuration command to update the server and the one or more POC analyzer(s) via the user interface of the portable computing device;
in response to receiving the certification configuration command, generating by the portable computing device a certification configuration request indicative of the certification configuration command, the certification configuration request comprising,
the one or more operator identifier(s) corresponding to the identified operator(s), and
data identifying the selected system certification(s), wherein the certification configuration request further comprises one or more of the following: addition of an operator status corresponding to the identified operator (s) and/or removal of an operator status corresponding to the identified operator(s) and/or update of an operator status corresponding to the identified operator(s);
transmitting by the portable computing device the certification configuration request to the server;
receiving by the server the certification configuration request;
updating by the server the selected system certification(s) according to the certification configuration request;
transmitting by the server an analyzer certification update for each of the selected system certification(s) to the corresponding POC analyzer(s), wherein the analyzer certification update comprises one or more of the following: one or more operator identifier(s) corresponding to the identified operator(s) to be granted access to the respective POC analyzer and/or one or more operator identifier(s) corresponding to the identified operator(s) to be denied access to the respective POC analyzer and/or one or more operator identifier(s) corresponding to the identified operator(s) to be granted limited access to the respective POC analyzer;
receiving by the one or more POC analyzer(s) the analyzer certification update; and
updating by the one or more POC analyzer(s) their respective analyzer certification according to the analyzer certification update, wherein an analyzer certification is a certification stored on a POC analyzer.

### Claim 2 (depends on 1)

The method for configuration of a POC testing system according to claim 1, wherein the server transmitting an analyzer certification update for each of the selected system certification(s) to the corresponding POC analyzer(s), the one or more POC analyzer(s) receiving the analyzer certification update, and the one or more POC analyzer(s) updating their respective analyzer certification according to the analyzer certification update are initiated by one or more POC analyzer(s) requesting an analyzer certification update.

### Claim 3 (depends on 2)

The method for configuration of a POC testing system according to claim 2, wherein one or more POC analyzer(s) requests an analyzer certification update on occurrence(s) of certain event(s) and/or at regular intervals.

### Claim 4 (depends on 1)

The method for configuration of a POC testing system according claim 1, further comprising,
storing one or more certification criteria corresponding to selected system certification(s) on the server;
selecting one or more certification criteria via the user interface within the step of receiving the certification configuration command;
including by the portable computing device the one or more certification criteria in the certification configuration request;
controlling access of the identified operator(s) to the respective POC analyzer by the one or more POC analyzer(s) according to the one or more certification criteria of the selected system certification(s).

### Claim 5 (depends on 1)

The method for configuration of a POC testing system according to claim 1, wherein the one or more operator identifier(s) are identifier tags.

### Claim 6 (depends on 1)

The method for configuration of a POC testing system according to claim 1, wherein the portable computing device comprises an identifier reader.

### Claim 7 (depends on 1)

The method for configuration of a POC testing system according to claim 1, further comprising,
retrieving by the portable computing device of one or more system certification(s) from the server.

### Claim 8 (depends on 1)

The method for configuration of a POC testing system according to claim 1, wherein the one or more system certification(s) comprises a list of authorized operators for a group of one or more POC analyzer(s).

### Claim 9 (depends on 1)

The method for configuration of a POC testing system according to claim 1, wherein the analyzer certification update comprises a list of authorized operators specific for the respective POC analyzer(s).

### Claim 10

A point of care (POC) testing system, the POC testing system comprising:
one or more POC analyzer(s) for analyzing one or more patient sample(s), the POC analyzer(s) each having an analyzer identifier for identifying the POC analyzer(s);
a server for storing one or more system certification(s), each corresponding to one or more POC analyzer(s), wherein the one or more system certification(s) are certifications stored on the server and wherein a certification is indicative of user(s) being authorized to use one or more of the one or more POC analyzer(s) with respect to one or more functions of the one or more of the one or more POC analyzer(s);
a portable computing device of a POC coordinator responsible for maintenance of the one or more POC analyzer(s), the portable computing device is configured to identify one or more operator(s) of the POC testing system using one or more operator identifier(s), each operator identifier uniquely identifying the respective operator, wherein the portable computing device comprises a user interface configured to enable selection of one or more system certification(s) by the POC coordinator, wherein the portable computing device is not a POC analyzer, wherein the portable computing device is configured to receive a certification configuration command to update the server and the one or more POC analyzer(s) via the user interface, and wherein the portable computing device is configured to generate and transmit to the server, in response to receiving the certification configuration command, a certification configuration request indicative of the certification configuration command, the certification configuration request comprising one or more operator identifier(s) corresponding to the identified operator(s) and data identifying the selected system certification(s), wherein the certification configuration request further comprises one or more of: addition of an operator status corresponding to the identified operator (s) and/or removal of an operator status corresponding to the identified operator(s) and/or update of an operator status corresponding to the identified operator(s); and
a communication network configured to communicatively connect the one or more POC analyzer(s) and the portable computing device with the server, wherein the server is configured to receive the certification configuration request, wherein the server is configured to update the selected system certification(s) within the server according to the certification configuration request, wherein the server is configured to transmit an analyzer certification update for each of the selected system certification(s) to the corresponding POC analyzer(s), the analyzer certification update comprising one or more of the following: one or more operator identifier(s) corresponding to the identified operator(s) to be granted access to the respective POC analyzer and/or one or more operator identifier(s) corresponding to the identified operator(s) to be denied access to the respective POC analyzer and/or one or more operator identifier(s) corresponding to the identified operator(s) to be granted limited access to the respective POC analyzer, and wherein the one or more POC analyzer(s) are configured to receive the analyzer certification update and to update their respective analyzer certification according to the analyzer certification update, wherein an analyzer certification is a certification stored on a POC analyzer.

### Claim 11 (depends on 10)

The POC testing system according to claim 10, wherein the one or more POC analyzer(s) are configured to request an analyzer certification update on occurrence(s) of certain event(s) and/or at regular intervals.

### Claim 12 (depends on 10)

The POC testing system according to claim 10, wherein the portable computing device is configured to request the one or more system certifications and/or a list of the one or more system certifications from the server.

### Claim 13 (depends on 10)

The POC testing system according to claim 10, wherein the server is configured to transmit the one or more system certifications and/or a list of the one or more system certifications to the portable computing device.