Quality assured analytical testing system and method thereof

• US 8,495,707 B2
• Filed: 08/19/2009
• Issued: 07/23/2013
• Est. Priority Date: 08/20/2008
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Miller, Steven
• Primary Examiner(s): Kim, Jung
• Assistant Examiner(s): Jamshidi, Ghodrat
• Application Number:
  US12/543,610
• Publication Number:
  US 20100050236A1
• Time in Patent Office: 1,434 Days
• Field of Search: 726/3
• US Class Current: 726/3
• CPC Class Codes: G06F 21/33 using certificates
• CPC Class Codes: G06F 21/62 Protecting access to data via a platform, e.g. using keys or access control rules
• CPC Class Codes: G06F 21/629 to features or functions of an application
• CPC Class Codes: G09B 19/24 Use of tools
• CPC Class Codes: G09B 23/28 for medicine
• CPC Class Codes: G09B 7/02 of the type wherein the student is expected to construct an answer to the question which is presented or wherein the machine gives an answer to the question presented by a student
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

A system and method for quality assured analytical testing is disclosed. A user is prompted by the system questions which relate to an analytical test to be conducted or an analytical instrument to be employed. Input received by the system from the user is evaluated to determine to which degree the inputs are correct. The user is certified if the determined degree is above a preset threshold. Next, the user is prompted by the system for a user identification and if the user is a certified user, access is provided to a testing routine of the analytical instrument.

Claims

1. A system for quality assured analytical testing, comprising:

an Instrument Management System (IMS);

an analytical instrument for conducting analytical testing, the analytical instrument having an input section for determining an actual user of the instrument and the analytical instrument being configured to run a testing routine; and

a terminal connected to the Instrument Management System (IMS) which is remote from the analytical instrument and which provides an examination module of the IMS that is programmed to;

conduct an exam during which the examination module prompts questions to the user via the terminal which relate to the analytical instrument and/or a diagnostic test to be conducted therewith,

receive via the terminal answers from the user to the questions,

evaluate the answers,

determine if the user has passed the exam, and

transmit a user certificate to the analytical instrument if the user passed the exam,

wherein the analytical instrument is programmed to check if a user certificate for the actual user is available and grant access to the testing routine by the user for conducting an analytical test only if a user certificate is available,

wherein the IMS is configured to relay the user certificate to the analytical instrument, and

wherein the IMS is a server.

2. The system of claim 1, wherein the analytical instrument communicates with the IMS and the IMS is configured to receive testing data from the analytical instrument.

3. The system of claim 1, wherein the user certificate comprises a user identification (ID) and optionally a user password.

4. The system of claim 1, wherein the analytical instrument is a handheld meter with an input section for inputting at least an user identification.

5. The system of claim 1, wherein analytical testing is performed extra corporally by reacting a patient sample with a reagent.

6. The system of claim 5, wherein said analytical testing is performed with a test element containing a reagent reacting with an analyte in the sample.

7. The system of claim 1, wherein the examination module is at least partially programmed by a supervisor to conduct an exam with questions specified by the supervisor.

12. The system of claim 1, wherein the analytical instrument is programmed to check if a user certificate for the actual user is available by determining if the user is on a list of certified users.

13. The system according to claim 1, wherein the terminal is a client computer connected to the Instrument Management System.

8. A method for quality assured analytical testing, comprising:

prompting questions to a user which relate to an analytical test to be conducted or an analytical instrument to be employed, wherein the prompting questions and receiving answers are both conducted at a terminal connected to an Instrument Management System, and wherein the terminal provides an examination module of the Instrument Management System and is remote from the analytical instrument;

receiving the answers from the user to the questions;

evaluating the answers and determining, via the examination module, to which degree the answers are correct;

certifying the user, via the examination module, if the determined degree is above a preset threshold;

transmitting, via the examination module, a user certification to the analytical instrument;

prompting, via the analytical instrument, the user to input a user identification;

determining, via the analytical instrument, if the user is a certified user; and

providing access to a testing routine of the analytical instrument if the user is a certified user, wherein the transmitting of the user certificate is via the Instrument Management System relaying the user certificate to the analytical instrument, and wherein the Instrument Management System is a server.

9. The method of claim 8 further comprising conducting an analytical test using the analytical instrument.

10. The method of claim 9 further comprising transmitting from the analytical instrument a result of the analytical test to the Instrument Management System.

11. The method according to claim 9, wherein said analytical testing is performed extra corporally by use of a test element which is used by the analytical instrument.

14. The method according to claim 8, wherein determining, via the analytical instrument, if the user is a certified user is performed by determining if the user is on a list of certified users.

15. The method according to claim 8, further comprising directly connecting the analytical instrument to the terminal and then transmitting the user certificate to the analytical instrument.

16. The method according to claim 8, wherein the terminal is a workstation terminal.