Quality assured analytical testing system and method thereof

• US 8,990,894 B2
• Filed: 07/08/2013
• Issued: 03/24/2015
• 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): Shaw, Yin-Chen
• Assistant Examiner(s): Jamshidi, Ghodrat
• Application Number:
  US13/936,452
• Publication Number:
  US 20130302770A1
• Time in Patent Office: 624 Days
• Field of Search: 726/3, 713/171
• 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 administering an examination for quality assured analytical testing by an actual user and for managing an analytical instrument by an administrator comprising:

the 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

a server connected to the analytical instrument and which runs an Instrument Management System (IMS) program which provides an examination module that is at least hosted on the server and programmed to;

conduct the examination 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 directly from the examination module to the analytical instrument if the actual user passed the exam, wherein the microprocessor of the analytical instrument is programmed to check if the 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 the user certificate is available for the actual user; and

a Learning Management System (LMS) workstation connected to the server, the LMS workstation being a different component in the system from the analytical instrument and which is configured to permit the administrator to log into the server;

to manage the analytical instrument and decide which users of the analytical instrument need training; and

to set a time frame via the LMS workstation for which the user certificate is valid;

the IMS program is configured to delete a user certificate if the actual user fails the examination or if the time frame for which the user certificate is valid has expired by deleting the user certificate from a list of certified users; and

the microprocessor of the analytical instrument is programmed to download program data or content data to the analytical instrument via the LMS workstation to check if the user certificate for the actual user is available by determining if the actual user is on the list of certified users, and deny access to the analytical testing routine if the actual user is not on the list of certified users.

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

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

4. The system of claim 1, wherein the server is configured to provide the examination module to a terminal of the server that is remote from the analytical instrument, wherein the analytical instrument communicates with the server and the 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, and wherein the direct transmission comprises a pull service where the analytical instrument pulls the user certificate from the examination module.

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 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, wherein the LMS workstation is configured to permit the administrator to retrieve analytical data from the analytical instrument, and download program data or content data to the analytical instrument.

11. The system of claim 1, wherein the LMS workstation is configured to permit the administrator to retrieve user data from the 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.

12. The system of claim 1, wherein the LMS workstation is configured to permit the 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.

13. The system of claim 1, wherein the server is configured to provide the examination module to a terminal of the server that is remote from the analytical instrument, the LMS workstation being a different component in the system from the terminal.

14. The system according to claim 13, wherein the terminal and the LMS workstation are each a client computer connected to the server.

15. A method of administering an examination for quality assured analytical testing by an actual user and for managing an analytical instrument by an administrator comprising:

providing;

a server connected to an analytical instrument and which runs an Instrument Management System (IMS) program which provides an examination module that is at least hosted on the server; and

a Learning Management System (LMS) workstation connected to the server, the LMS workstation being a different component in the system from the analytical instrument and which is configured to permit the administrator to log into the server to manage the analytical instrument and decide which users of the analytical instrument need training;

prompting, via the examination module, questions to the actual user which relate to an analytical test to be conducted or the analytical instrument to be employed;

receiving, via the examination module, the answers from the actual user to the questions;

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

certifying the actual user, via the examination module, upon the determined degree being above a preset threshold; and

transmitting, upon the actual user being certified by the examination module, a user certificate directly from the examination module to the analytical instrument which permits access of the actual user to the analytical test to be conducted or the analytical instrument;

setting, by the administrator, a time frame via the LMS for which the user certificate is valid;

deleting the user certificate if the actual user fails the examination or if the time frame for which the user certificate is valid has expired by deleting the user certificate from a list of certified users; and

checking via the microprocessor of the analytical instrument if the user certificate for the actual user is available by determining if the actual user is on the list of certified users; and

denying access to an analytical testing routine if the actual user is not on the list of certified users.

16. The method of claim 15, further comprising providing the examination module to either the analytical instrument or a terminal that is connected to the server and which is remote from the analytical instrument.

17. The method of claim 15, further comprising logging in to the server via an intranet or web-based tool via a client computer to take the exam.

18. The method of claim 15, further comprising providing the user certification transmitted from the server to the analytical instrument via a TCP/IP client connected to the server.

19. The method of claim 15, further comprising transmitting from the analytical instrument to the IMS server a result of an analytical test conducted by an actual user having the user certificate on the analytical instrument.

20. The method of claim 15, further comprising programming the examination module at least partially by a supervisor or manufacturer of the analytical instrument.

21. The method of claim 15, further comprising retrieving analytical data from the analytical instrument, and downloading program data or content data to the analytical instrument via the (LMS) LMS workstation connected to the server.

22. The method of claim 15, further comprising retrieving user data from the 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 the LMS workstation connected to the server.

23. The method of claim 15, further comprising certifying or installing the examination via the LMS workstation connected to the server.

24. The method of claim 23, further comprising providing the examination module to a terminal of the server that is remote from the analytical instrument, and wherein the terminal is a different component from the LMS workstation and the analytical instrument.

25. The method of claim 15 further comprising conducting the examination directly on the analytical instrument.