QUALITY ASSURED ANALYTICAL TESTING SYSTEM AND METHOD THEREOF

• US 20130302770A1
• Filed: 07/08/2013
• Published: 11/14/2013
• 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
• Granted Patent: US 8,990,894 B2
• Time in Patent Office: Days
• US Class Current: 434/262
• 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 administering an examination for quality assured analytical testing by an actual user, comprising:

an analytical instrument comprising a microprocessor programmed to conduct an analytical testing routine, and an input section to determine the actual user of the instrument, the microprocessor being further programmed to check if the actual user is a certified user permitted to conduct the testing routine; and

an Instrument Management System (IMS) server which provides an examination module of the IMS server that is programmed to;

conduct an exam during which the examination module prompts questions to the actual user which relate to at least one of the analytical instrument and a diagnostic test to be conducted therewith,

receive answers from the actual user to the questions,

evaluate the answers,

determine if the actual user has passed the exam, and

transmit a user certificate from the IMS server to the analytical instrument if the actual user passed the exam, wherein the microprocessor of the analytical instrument is programmed to check if a user certificate for the actual user is available and grant access to the analytical testing routine by the actual user for conducting an analytical test only if a user certificate is available for the actual user.

2. The system of claim 1, wherein the IMS server is configured to provided the examination module to the analytical instrument.

3. The system of claim 1, wherein the IMS server is configured to permit the actual user to log in to the IMS server via an intranet or web-based tool via a client computer to take the exam.

4. The system of claim 1, wherein the IMS server is configured to provide the examination module to a terminal of the IMS server that is remote from the analytical instrument, wherein the analytical instrument communicates with the IMS server and the IMS server is configured to both receive testing data from the analytical instrument and relay the user certificate to the analytical instrument from the terminal.

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

6. The system of claim 1, wherein the analytical instrument is a handheld meter with the input section and which determines the actual user of the instrument via an inputted user identification.

7. The system of claim 1, wherein the analytical instrument tests an analyte in an extra corporally provided sample via a test element containing a reagent.

8. The system of claim 1, wherein the analytical instrument is an instrument selected from a bedside testing instrument, a blood glucose meter, a coagulation testing meter, an endogenic proteins testing instrument, a metabolites testing instrument, a nucleic acids testing instrument, a blood gas analyzer, and a patient sample analyzer.

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

10. The system of claim 1, further comprising a Learning Management System (LMS) workstation connected to the IMS server, the LMS workstation being a different component in the system from the analytical instrument and which is configured to permit an administrator to log into the IMS server to manage the analytical instrument and decide which users of the analytical instrument need training.

11. The system of claim 10, wherein the LMS workstation is configured to permit a logged in administrator to retrieve analytical data from the analytical instrument, and download program data or content data to the analytical instrument.

12. The system of claim 10, wherein the LMS workstation is configured to permit a logged in administrator to retrieve user data from the IMS server, review active users of the analytical instrument, make changes to a user list of the analytical instrument, and enter into IMS data further users who will do testing with the analytical instrument.

13. The system of claim 10, wherein the LMS workstation is configured to permit a logged in administrator to certify or install a provided exam, create questions for a new exam, retrieve an existing exam for editing, and transmit exam information to the analytical instrument.

14. The system of claim 1, wherein the microprocessor of 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.

15. The system according to claim 1, wherein the analytical instrument is programmed to check whether the user certificate is valid, and wherein the user certificate expires automatically after a designated time period.

16. The system of claim 1, wherein the IMS server is configured to provide the examination module to a terminal of the IMS server that is remote from the analytical instrument, and further comprises a Learning Management System (LMS) workstation connected to the IMS server, the LMS workstation being a different component in the system from the terminal and which permits an administrator to log into the IMS server to manage the analytical instrument and decide which users of the analytical instrument need to take the exam via the terminal.

17. The system according to claim 16, wherein the terminal and LMS workstations are each a client computer connected to the IMS server.

18. A method administering an examination for quality assured analytical testing by a user, comprising:

prompting, via an examination module provided by an Instrument Management System (IMS) server, questions to the user which relate to an analytical test to be conducted or an analytical instrument to be employed;

receiving, via the examination module, 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, upon the determined degree being above a preset threshold; and

transmitting from the IMS server upon the user being certified by the examination module, a user certification to the analytical instrument which permits access of the user to the analytical test to be conducted or the analytical instrument.

19. The method of claim 18, further comprises providing the examination module to either the analytical instrument or a terminal that is connected to the IMS server and which is remote from the analytical instrument.

20. The method of claim 18, further comprises logging in to the IMS server via an intranet or web-based tool via a client computer to take the exam.

21. The method of claim 18, further comprises providing the user certification transmitted from the IMS server to the analytical instrument via a TCP/IP client connected to the IMS server.

22. The method of claim 18, further comprises checking, via the analytical instrument, whether the user certificate for the user is available by determining if the user is on a list of certified users.

23. The method of claim 18, further comprises checking, via the analytical instrument, whether the user certificate is valid, wherein the user certificate expires automatically after a designated time period.

24. The method of claim 18, further comprises transmitting from the analytical instrument to the IMS server a result of an analytical test conducted by a user having a user certification on the analytical instrument.

25. The method of claim 18, further comprises programming the examination module at least partially by a supervisor or manufacturer of the analytical instrument.

26. The method of claim 18, further comprises managing the analytical instrument and deciding which users of the analytical instrument need training from a Learning Management System (LMS) workstation connected to the IMS server, the LMS workstation being a different component from the analytical instrument.

27. The method of claim 18, further comprises retrieving analytical data from the analytical instrument, and downloading program data or content data to the analytical instrument via a Learning Management System (LMS) workstation connected to the IMS server, the LMS workstation being a different component from the analytical instrument.

28. The method of claim 18, further comprises retrieving user data from the IMS server, reviewing active users of the analytical instrument, making changes to a user list of the analytical instrument, and entering into IMS data further users who will do testing with the analytical instrument via a Learning Management System (LMS) workstation connected to the IMS server, the LMS workstation being a different component from the analytical instrument.

29. The method of claim 18, further comprises certifying or installing the exam via a Learning Management System (LMS) workstation connected to the IMS server, the LMS workstation being a different component from the analytical instrument.

30. The method of claim 29, further comprises providing the examination module to a terminal of the IMS server that is remote from the analytical instrument, and wherein the terminal is a different component from LMS workstation and analytical instrument.