System and method for managing medical data

• US 7,689,439 B2
• Filed: 02/14/2006
• Issued: 03/30/2010
• Est. Priority Date: 02/14/2006
• Status: Active Grant

• Current Assignee: IQVIA, Inc. (IQVIA Holdings, Inc.)
• Original Assignee: Quintiles Transnational Corporation (IQVIA Holdings, Inc.)
• Inventors: Parker, Jason
• Primary Examiner(s): O'Connor; Gerald J.
• Assistant Examiner(s): PHONGSVIRAJATI, POONSIN
• Application Number:
  US11/354,062
• Publication Number:
  US 20070191721A1
• Time in Patent Office: 1,505 Days
• Field of Search: 705 2- 3, 600/300
• US Class Current: 705/2
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

According to various embodiments of the present invention, a data management process is provided that manages ECG data collection, review, and reporting in an efficient and secure manner by utilizing biometric checks, quality control measures, and workflow control systems that route data based on a variety of factors to efficiently complete the measurement and analysis process.

Claims

1. A system comprising:

a technician workflow system comprising a processor capable of causing the technician workflow system to;

receive electrocardiogram (ECG) data associated with a requested review completion time, the ECG data being associated with at least one patient participating in a clinical trial, the requested review completion time being associated with the clinical trial;

receive a number representing an amount of distributed ECG data present in each technician queue associated with at least one technician among a plurality of technicians,

determine a technician among the plurality of technicians to receive the ECG data that is associated with the requested review completion time based on the requested review completion time and the amount of distributed ECG data present in each technician queue to allow the technician among the plurality of technicians to obtain a measurement of the ECG data before the requested review completion time; and

provide the ECG data associated with the requested review completion time to a technician queue of the technician among the plurality of technicians determined to receive the ECG data; and

a cardiologist workflow system comprising a system processor capable of causing the cardiologist workflow system to;

receive the ECG data and the measurement from the technician workflow system;

receive a number representing an amount of distributed ECG data present in each cardiologist queue that is associated with at least one cardiologist among a plurality of cardiologists,

determine a cardiologist among the plurality of cardiologists to receive the ECG data and the measurement based on the requested review completion time and the amount of distributed ECG data present in each cardiologist queue to allow the cardiologist among the plurality of cardiologists to review the measurement made by the technician of the ECG data before the requested review completion time;

provide the ECG data associated with the requested review completion time to a cardiologist queue of the cardiologist among the plurality of cardiologists determined to receive the ECG data; and

receive a report created by the cardiologist among the plurality of cardiologists, the report comprising a result of the review by the cardiologist of the measurement.

2. The system of claim 1, further comprising:

an initial quality control system configured to;

receive the ECG data associated with the requested review completion time and patient information of a plurality of patients associated with the ECG data from at least one testing center;

analyze the ECG data for one or more errors by comparing the ECG data to pre-set ECG parameters; and

analyze the patient information for one or more errors by comparing the patient information to patient information parameters,

wherein the technician workflow system is configured to receive the ECG data and the patient information from the initial quality control system.

3. The system of claim 1, further comprising:

a post-analysis diagnosis system configured to;

receive the report;

compare the measurement in the report to a predetermined parameter range;

transmit a notification to the cardiologist workflow system if the measurement is outside the predetermined parameter range, the notification comprising the measurement, the ECG data, and an identification of measurement as being outside the predetermined parameter range; and

transmit the report to at least one testing center if the measurement is within the predetermined parameter range.

4. The system of claim 3, wherein the post-analysis diagnosis system is configured to:

receive a confirmation from the cardiologist workflow system in response to the notification that the measurement is outside the predetermined parameter; and

transmit the report to the at least one testing center.

5. The system of claim 1, wherein the technician workflow system is configured to:

receive a biometric signature from the technician, the biometric signature identifying the technician;

associate the biometric signature with the ECG data; and

transmit the ECG data to the cardiologist workflow system only if the biometric signature is valid.

6. The system of claim 1, wherein the cardiologist workflow system is configured to:

receive a biometric signature from the cardiologist, the biometric signature identifying the cardiologist;

associate the biometric signature with the ECG data; and

receive the report from the cardiologist only if the biometric signature is valid.

7. The system of claim 1, wherein the cardiologist workflow system is configured to determine the cardiologist among the plurality of cardiologists to receive the ECG data and the measurement based on the requested review completion time and the amount of distributed ECG data present in each cardiologist queue by:

determining a shift ending time for each cardiologist of the plurality of cardiologists; and

identifying the cardiologist of the plurality of cardiologists having an ability to review the ECG data and the measurement before the requested review completion time and before the shift ending time for the cardiologist.

8. The system of claim 1, further comprising:

a server device capable of determining an absence of ECG data for a patient at an end of an expected receipt time and transmitting a notification to the at least one testing center, the notification indicating that the ECG data for the patient is overdue.

9. The system of claim 1, wherein the cardiologist workflow system is configured to:

receive the report comprising a command to re-measure the ECG data; and

transmit the ECG data to the technician workflow system for re-measurement by a technician among the plurality of technicians in response to the command.

10. A method comprising:

receiving electrocardiogram (ECG) data associated with a requested review completion time, the ECG data being associated with at least one patient participating in a clinical trial, the requested review completion time being associated with the clinical trial;

determining, by a technician workflow system, a technician among a plurality of technicians to receive the ECG data associated with the requested review completion time based on the requested review completion time and an amount of distributed ECG data present in each technician queue of a plurality of technician queues to allow the technician among the plurality of technicians to obtain a measurement of the ECG data before the requested review completion time, the technician workflow system comprising a processor capable of causing the technician workflow system to determine the technician among the plurality of technicians to receive the ECG data;

providing, by the technician workflow system, the ECG data associated with the requested review completion time to a technician queue associated with the technician among the plurality of technicians determined to receive the ECG data; and

receiving the ECG data and the measurement from the technician workflow system;

determining, by a cardiologist workflow system, a cardiologist among a plurality of cardiologists to receive the ECG data and the measurement by the technician based on the requested review completion time and an amount of distributed ECG data and distributed measurements present in each cardiologist queue of a plurality of cardiologist queues to allow the cardiologist among the plurality of cardiologists to review the measurement made by the technician of the ECG data before the requested review completion time, the cardiologist workflow system comprising a processor capable of causing the cardiologist workflow to determine the cardiologist among the plurality of cardiologists to receive the ECG data and the measurement by the technician;

providing, by the cardiologist workflow system, the ECG data associated with the requested review completion time to a cardiologist queue associated with the cardiologist among the plurality of cardiologists determined to receive the ECG data; and

receiving a report created by the cardiologist among the plurality of cardiologists, the report comprising a result of the review by the cardiologist of the measurement.

11. The method of claim 10, further comprising:

receiving the ECG data associated with the requested review completion time and patient information of at least one patient associated with the ECG data from a testing center;

analyzing the ECG data for one or more errors by comparing the ECG data to pre-set ECG parameters;

analyzing the patient information for one or more errors by comparing the patient information to patient information parameters; and

sending a notification to the testing center if the one or more errors for the ECG data or for the patient information is detected.

12. The method of claim 10, further comprising:

comparing the measurement in the report to a predetermined parameter range;

transmitting a notification to the cardiologist workflow system if the measurement is outside the predetermined parameter range, the notification comprising the measurement, the ECG data, and an identification of measurement as being outside the predetermined parameter range; and

transmitting the report to at least one testing center if the measurement is within the predetermined parameter range.

13. The method of claim 12, further comprising:

receiving a confirmation from the cardiologist workflow system in response to the notification that the measurement is outside the predetermined parameter; and

transmitting the report to the at least one testing center.

14. The method of claim 10, further comprising:

receiving a biometric signature from the technician, the biometric signature identifying the technician;

associating the biometric signature with the ECG data; and

transmitting the ECG data to the cardiologist workflow system only if the biometric signature is valid.

15. The method of claim 10, further comprising:

receiving a biometric signature from the cardiologist, the biometric signature identifying the cardiologist;

associating the biometric signature with the ECG data; and

receiving the report from the cardiologist only if the biometric signature is valid.

16. The method of claim 10, wherein determining the cardiologist among the plurality of cardiologists to receive the ECG data and the measurement by the technician based on the requested review completion time and the amount of distributed ECG data and distributed measurements present in each cardiologist queue of a plurality of cardiologist queues by:

determining a shift ending time for each cardiologist of the plurality of cardiologists; and

identifying the cardiologist of the plurality of cardiologists having an ability to review the ECG data and the measurement before the requested review completion time and before the shift ending time for the cardiologist.

17. The method of claim 10, further comprising:

determining an absence of ECG data for a patient at an end of an expected receipt time, the ECG data for the patient being expected to be received from at least one testing center; and

transmitting a notification to the at least one testing center, the notification indicating that the ECG data for the patient is overdue.

18. The method of claim 10, further comprising:

receiving the report comprising a command to re-measure the ECG data; and

transmitting the ECG data to the technician workflow system for re-measurement by a technician among the plurality of technicians in response to the command.

19. A system comprising:

a plurality of queues configured to store distributed electrocardiogram (ECG) data, wherein each queue of the plurality of queues is accessible to a technician or a cardiologist;

a device in communication with the each queue of the plurality of queues, the device comprising a processor configured to cause the device to;

receive patient information and ECG data originating from a testing center, the patient information and the ECG data being associated with a patient participating in a clinical trial conducted at the testing center and associated with a requested review completion time in accordance with the clinical trial;

receive an amount of distributed ECG data located in each queue of the plurality of queues;

for each queue of the plurality of queues, receive a shift ending time associated with the queue, the shift ending time corresponding to an end of a shift for the technician or the cardiologist capable of accessing the queue;

identifying the queue among the plurality of queues to which to distribute the ECG data based on;

the requested review completion time;

the amount of distributed ECG data located in each queue of the plurality of queues; and

the shift ending time for each queue of the plurality of queues,

to allow the technician or the cardiologist associated with the queue to complete an analysis of the ECG data before the requested review completion time, wherein the analysis comprises at least one of a measurement or a report; and

distributing the ECG data to the queue among the plurality of queues identified to which to distribute the ECG data.

20. The system of claim 19, wherein the device is further capable of:

analyzing the ECG data originating from the testing center for one or more errors by comparing the ECG data to pre-set ECG parameters;

analyzing the patient information originating from the testing center for one or more errors by comparing the patient information to patient information parameters; and

sending a notification to the testing center if the one or more errors for the ECG data or for the patient information is detected.

21. The system of claim 19, wherein the analysis is the report comprising the measurement, the device being configured to:

compare the measurement in the report to a predetermined parameter range;

redistribute the ECG data to a queue among the plurality of queues if the measurement is outside the predetermined parameter range; and

transmit the report comprising the measurement to the testing center if the measurement is within the predetermined parameter range.

22. The system of claim 21, wherein the device is configured to:

receive a confirmation from at least one of the technician or the cardiologist that the measurement is outside the predetermined parameter; and

transmitting the report comprising the measurement to the testing center.

23. The system of claim 21, wherein the analysis comprises a biometric signature from at least one of the technician or the cardiologist, the device being configured to:

determine a validity of the biometric signature; and

transmit the report comprising the measurement to the testing center only if the biometric signature is valid.

24. The system of claim 19, wherein the device is further capable of:

determining an absence of ECG data for a patient at an end of an expected receipt time from the testing center; and

transmitting a notification to the testing center, the notification indicating that the ECU data for the patient is overdue.