Hematology analyzer, method, and system for quality control measurements

• US 10,514,385 B2
• Filed: 07/22/2011
• Issued: 12/24/2019
• Est. Priority Date: 07/22/2011
• Status: Active Grant

• Current Assignee: Sysmex Corporation
• Original Assignee: Sysmex Corporation
• Inventors: Ausdenmoore, James, Osella, Peter, Taylor, Ralph
• Primary Examiner(s): Hixson, Christopher Adam
• Assistant Examiner(s): Adams, Michelle
• Application Number:
  US13/189,175
• Publication Number:
  US 20130023006A1
• Time in Patent Office: 3,077 Days
• Field of Search: 436 43- 54
• CPC Class Codes: G01N 35/00603 Reinspection of samples
• CPC Class Codes: G01N 35/00623 of instruments
• CPC Class Codes: G01N 35/00663 of consumables

Abstract

An analyzer for measuring a sample includes a display, measurement hardware configured to perform a quality control measurement on a vial containing a quality control (QC) sample, and a controller. The controller is in communication with the display and the measurement hardware and is configured to communicate, via the display, instructions to implement a QC measurement on a first vial containing a first QC sample. If a result of the QC measurement is within a pre-determined range the first vial passes the QC measurement. If the result of the QC measurement is not within the pre-determined range the first vial fails the QC measurement. If the first vial fails the QC measurement and if a number of times the first vial fails the QC measurement is less than a predetermined number, the controller is configured to communicate, via the display, instructions to repeat the QC measurement on the first vial.

Claims

1. A hematology analyzer for measuring a blood sample, the hematology analyzer comprising:

a display;

measurement hardware configured to measure blood constituents contained in a blood sample collected from a subject; and

a controller in communication with the display and the measurement hardware, the controller configured to;

control the display to indicate an instruction to implement a first quality control (QC) measurement on a first vial containing a first QC sample;

control the display to indicate an instruction to repeat the first QC measurement on the first vial if a result of the first QC measurement on the first QC sample by the measurement hardware is not within a first predetermined range and a number of times that the result of the first QC measurement is not within the first predetermined range is less than a predetermined number greater than one;

control the display to indicate an instruction to implement a second QC measurement on a second vial that contains a second QC sample having a consistency that substantially matches the first QC sample of the first vial if the result of the first QC measurement on the first QC sample, by the measurement hardware, that has been measured is not within the first predetermined range and the number of times is greater than or equal to the predetermined number;

control the display to indicate an instruction to implement a third QC measurement on a third vial that contains a third QC sample having a different concentration from the first QC sample if a result of the second QC measurement on the second QC sample, by the measurement hardware, that has been measured is within the first predetermined range; and

control the measurement hardware to allow measurements of the blood sample collected from the subject to be performed if a result of the third QC measurement on the third QC sample, by the measurement hardware, that has been measured is within a second predetermined range.

2. The hematology analyzer according to claim 1, wherein if the result of the second QC measurement that has been measured is not within the first predetermined range and a second number of times that the result of the second QC measurement is not within the first predetermined range is less than a second predetermined number greater than one, the controller is configured to communicate instructions for repeating the second QC measurement on the second vial via the display, and if the result of the second QC measurement on the second vial, by the measurement hardware, that has been measured is not within the first predetermined range and the second number of times is greater than or equal to the second predetermined number, the controller is configured to communicate, via the display, instructions to contact service personnel.

3. The hematology analyzer according to claim 1, wherein the predetermined number is two and the controller is configured not to communicate the instructions to perform the second QC measurement on the second vial before the number of times is greater than or equal to the predetermined number.

4. The hematology analyzer according to claim 1, wherein the controller is configured to store the number of times that the result of the first QC measurement is not within the first predetermined range.

5. The hematology analyzer according to claim 4, wherein the controller is configured to store a flag that the first vial is unusable if the number of times that the result of the first QC measurement is greater than or equal to the predetermined number.

6. The hematology analyzer according to claim 1, wherein the controller is configured to communicate information that defines whether the first vial fails the first QC measurement to a server that comprises a sample database that stores data that specifies information related to the first vial.

7. The hematology analyzer according to claim 6, wherein the controller is configured to communicate the number of times that the result of the first QC measurement is not within the first predetermined range to the server.

8. The hematology analyzer according to claim 7, wherein the controller is configured to communicate instructions to the server to mark the first vial as unusable if the number of times that the result of the first QC measurement is greater than or equal to the predetermined number.

9. The analyzer hematology according to claim 6, further comprising a barcode reader, wherein the controller is configured to communicate with the server to specify known quantities of substances in the first QC sample in the first vial in response to reading a barcode on the first vial by the barcode reader.

10. The analyzer hematology according to claim 1, wherein the controller is configured to control the display to indicate an instruction to implement the third QC measurement on the third vial if the result of the first QC measurement on the first QC vial, by the measurement hardware, that has been measured is within the first predetermined range.

11. A method for measuring a blood sample, comprising:

measuring, by measurement hardware of a hematology analyzer, blood constituents contained in a blood sample collected from a subject; and

displaying, on the hematology analyzer, an instruction to implement a first quality control (QC) measurement on a first vial containing a first QC sample;

displaying, on the hematology analyzer, an instruction to repeat the first QC measurement on the first vial in response to a result of the first QC measurement on the first QC sample by the measurement hardware is not within being outside of a first predetermined range and a number of times that the result of the first QC measurement is not within the first predetermined range being less than a predetermined number greater than one; and

displaying, on the hematology analyzer, an instruction to implement a second QC measurement on a second vial that contains a second QC sample having a consistency that substantially matches the first QC sample of the first vial in response to the result of the first QC measurement on the first QC sample, by the measurement hardware, that has been measured being outside the first predetermined range and the number of times being greater than or equal to the predetermined number;

displaying, on the hematology analyzer, an instruction to implement a third QC measurement on a third vial that contains a third QC sample having a different concentration from the first QC sample in response to the result of the second QC measurement on the second QC sample, by the measurement hardware, that has been measured being within the first predetermined range; and

controlling the measurement hardware to allow measurements of the blood sample collected from the subject to be performed in response to a result of the third QC measurement on the third QC sample, by the measurement hardware, that has been measured being within a second predetermined range.

12. The method according to claim 11, wherein the predetermined number is two.

13. A system comprising:

a hematology analyzer for measuring a blood sample; and

a server in communication with the hematology analyzer via a network,

the hematology analyzer comprising;

a display;

a barcode reader;

measurement hardware configured to measure blood constituents contained in a blood sample collected from a subject; and

a controller in communication with the display and the measurement hardware, the controller configured to;

control the display to indicate an instruction to implement a first quality control (QC) measurement in which the measurement hardware measures a quantity of a substance in a first QC sample contained in a first vial having a first barcode;

communicate with the server to send data of the first barcode read by the barcode reader and to receive a first known quantity of the substance in the first QC sample;

control the display to indicate an instruction to repeat the first QC measurement on the first vial if a result of a first QC measurement on the first QC sample by the measurement hardware is not within a first acceptable range of the first known quantity and a number of times that the result of the first QC measurement is not within the first acceptable range is less than a predetermined number greater than one;

control the display to indicate an instruction to implement a second QC measurement in which the measurement hardware measures a quantity of a substance in a second QC sample which is contained in a second vial having a second barcode and has a consistency that substantially matches the first QC sample of the first vial if a result of the first QC measurement on the first QC sample, by the measurement hardware, that has been measured is not within the first acceptable range and the number of times is greater than or equal to the predetermined number;

communicate with the server to send data of the second barcode read by the barcode reader and to receive the first known quantity of the substance in the second QC sample;

control the display to indicate an instruction to implement a third QC measurement in which the measurement hardware measures a quantity of a substance in a third QC sample which is contained in a third vial having a third barcode and contains a different quantity of the substance in the first QC sample if a result of the second QC measurement on the second QC sample, by the measurement hardware, that has been measured is within the first acceptable range of the first known quantity;

communicate with the server to send data of the third barcode scanned by the barcode reader and to receive a second known quantity of the substance in the third QC sample; and

control the measurement hardware to allow measurements of the blood sample collected from the subject to be performed if a result of the third QC measurement on the third QC sample, by the measurement hardware, that has been measured is within a second acceptable range of the second known quantity.

14. The system according to claim 13, wherein the controller is configured to control the display to indicate an instruction to implement the third QC measurement on the third vial if any of the results of the first QC measurement on the first QC vial, by the measurement hardware, that has been measured is within the first predetermined range.