QUALITY ASSURED ANALYTICAL TESTING SYSTEM AND METHOD THEREOF

• US 20100050236A1
• Filed: 08/19/2009
• Published: 02/25/2010
• 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
• Granted Patent: US 8,495,707 B2
• Time in Patent Office: Days
• 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 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 adapted to run a testing routine;

an examination module being programmed to conduct an exam during which it prompts questions to the user which relate to the analytical instrument and/or a diagnostic test to be conducted therewith and receives answers from the user to the questions and evaluates the answers; and

determines if the user has passed the exam, the examination module in case that the user passed the exam transmits a user certificate to the analytical instrument,

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

2. The system of claim 1, wherein the examination module comprises a software running on an Instrument Management System (IMS).

3. The system of claim 2, wherein the IMS is adapted to relay the user certificate to the analytical instrument and to receive testing data from the analytical instrument.

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

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

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

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

8. The system of claim 2, wherein the examination module comprises a terminal at which the user conducts the exam and the terminal is connected to the IMS.

9. 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.

10. 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;

receiving inputs from the user to those questions;

evaluating the inputs and determining to which degree the inputs are correct;

certifying the user if the determined degree is above a preset threshold;

prompting the user to input a user identification;

determining 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.

11. The method of claim 10, wherein prompting questions and receiving answers is conducted at a terminal connected to an Instrument Management System.

12. The method of claim 10 further comprising the step of conducting an analytical test.

13. The method of claim 12 further comprising the step of transmitting a result of the analytical test to an Instrument Management System.

14. The method according to claim 10, wherein the prompting to input a user identification is being performed by an analytical instrument.

15. The method according to claim 10, wherein said analytical testing is performed extra corporally by use of a test element.