TW201828239A - A testing instrument with determining quality controlling performance and a method thereof - Google Patents

Abstract

This disclosure is related to a testing instrument with determining quality controlling performance and a method thereof. The testing instrument includes a housing, a monitor, a scanning key, a scanning area, a strip slot and a control circuit. The test instrument has a nursing staff ID table, a strip corresponding table and a quality control testing performance table which all embedded in the control circuit. These three tables correspond with a step of determining the operator is same as one of the nursing staff ID table and a step of performing the quality control testing to achieve the automatically determining whether or not a quality control test has been performed and the automatically determining whether or not the quality control performed by the user has been passed. This disclosure is not only to improve the quality of inspection testing instrument and the quality control efficiency, but also enhance the quality of medical caring. Furthermore this disclosure can effectively apply to the current market a variety of testing instrument models, such as a variety of blood glucose instrument devices.

Description

 Inspection instrument with quality control judgment and detection method thereof  

The invention relates to an inspection instrument with quality control judgment and a detection method thereof, in particular to a bedside inspection instrument with high maneuverability, convenient clinical use and automatic execution quality control.

The prior art relates to Point-of-Care Testing (POCT), which has high mobility and is convenient for medical personnel to use clinically, but the main disadvantage is that it is difficult to monitor the inspection quality of the instrument, and often there is an inaccurate test. occur. Therefore, medical personnel are often required to conduct quality control tests. However, for a long time or busy work, the medical staff will easily forget to conduct quality control testing, or forget whether to do quality control testing, or the previous users have done quality control testing, but not Know if the previous quality control test has passed the test standard. Therefore, it is often the case that the bedside inspection instrument is inaccurate. In severe cases, even the measurement is inaccurate, the patient's condition is misjudged, and the patient's casualties occur, which needs to be improved.

The invention discloses an inspection instrument with quality control judgment and a detection method thereof. By performing an automatic judgment and comparison function in the process step of quality control, the screen is automatically imported to the next screen, and the operator does not need to test and judge by himself. Has the quality control test been completed, and there is no need to select the switching mode in various modes (such as switching to quality control mode or entering the mode of measuring patients), effectively improving the lack of existing technology and improving the efficiency of quality control of medical testing. And quality, and can be used in various bedside inspection instruments (POCT) available on the market.

The invention relates to an inspection instrument with quality control judgment, which is applied to a test strip tank and at least one quality control liquid, and performs an operation of quality control detection, the inspection apparatus comprises: a casing; a screen; a scan button disposed under the screen; a scan area disposed on a lower side of the case for scanning a bar code; and a test strip slot disposed on a side of the case A control circuit is disposed in the housing, the control circuit is coupled to the screen, the scan key, the scanning area and the test strip slot for controlling the operation of the inspection apparatus and performing various quality control tests. Alignment, and judge whether the quality control test passes; the control circuit stores a caregiver ID table, a test piece correspondence table, and a quality control test result table, and individually serves as a basis for performing comparison of various quality control tests. .

The inspection apparatus includes an access key and a return key disposed on an upper surface of the housing for providing an operator to conveniently operate the inspection instrument; the inspection apparatus is provided with a switch, the switch is disposed on the housing On one side, it is used to perform the inspection instrument on or off.

The invention provides a detection method for an inspection instrument with quality control judgment, which is applied to an inspection instrument with quality control judgment as described above, and also for matching the test strip tank and the at least one quality control liquid, the detection method Including: booting and scanning the staff barcode; judging whether it is the hospital's nursing staff; whether the quality control test has been done on the day; performing the quality control test; judging whether the quality control test has passed; if the quality control test passes, the disease is executed The measurement is measured.

The step of determining whether the patient is a nursing staff in the hospital is the information obtained after the barcode of the scanned person is compared with the nursing staff ID stored in the control circuit of the inspection instrument having the quality control judgment. If the table matches, it is judged as a nursing staff in the hospital.

After the step of quality control test has been performed on the day, if it has been done, it is judged whether the quality control test has passed; if it is passed, the patient measurement is performed; if not, the quality control test is performed. .

The step of determining whether the quality control detection has passed is a test piece data obtained by performing the quality control test, which is stored in the control circuit of the inspection instrument having the quality control judgment. The test piece correspondence table, if it matches, the test piece passes the test.

The step of determining whether the quality control detection has passed is the product liquid data obtained by performing the quality control detection, which is stored in the control circuit of the inspection instrument having the quality control judgment. The quality control test result table, if it is consistent, the quality control liquid is tested and passed.

The performing quality control detection step includes: scanning a test strip barcode; scanning a product liquid barcode; taking a test strip into the inspection instrument; dropping the test piece onto the quality control liquid; and obtaining a test value , compare the quality control test results table, and show whether it passes the test.

The performing quality control detection step includes: scanning a test strip barcode; scanning a first product liquid bar code; taking a first test piece and inserting the test instrument; and dropping the first test piece onto the first test piece The quality control liquid; obtaining the inspection value of the first test piece, comparing the quality control test result table, indicating whether the test is passed; scanning a second product liquid bar code; taking a second test piece and inserting the test instrument; The second test piece is dropped onto the second product tube liquid; and the test value of the second test piece is obtained, and the quality control test result table is compared to show whether the test is passed; wherein the first product liquid is a quality control test The upper limit value, the second product liquid is the lower limit of the quality control test.

The test instrument described therein is a bedside test instrument for detecting blood sugar.

10‧‧‧Testing instruments

10a‧‧‧shell

11‧‧‧ screen

12‧‧‧ scan key

13‧‧‧Scanning area

14‧‧‧Enter key

15‧‧‧ Back button

16‧‧‧ switch

17‧‧‧Test slot

18‧‧‧number keys

20‧‧‧Test cans

20a‧‧‧Test strip barcode

21‧‧‧First product tube

21a‧‧‧The first product liquid bar code

22‧‧‧Second product tube fluid

22a‧‧‧Second product pipe bar code

30‧‧‧Control circuit

31‧‧‧Central Computing Unit

32‧‧‧ Peripheral interface control circuit

33‧‧‧ memory

S10~S39‧‧‧Steps

1 is a perspective view of an embodiment of the present invention; FIG. 2 is another perspective view of a control circuit according to an embodiment of the present invention; FIG. 3 is a schematic block diagram of a control circuit according to an embodiment of the present invention; 4B is a schematic diagram of a test piece correspondence table according to an embodiment of the present invention; FIG. 4C is a schematic diagram of a quality control test result table according to an embodiment of the present invention; FIG. 5 is a flow chart of steps of an embodiment of the method according to the present invention; 6 is a flow chart of steps of an embodiment of a method for performing quality control detection according to the present invention; FIG. 7 is a flow chart of steps of another method for performing quality control detection according to the present invention; FIG. 8A is a schematic diagram of a screen of an operation inspection instrument according to the present invention; FIG. 8 is a schematic diagram of another screen of the operation inspection apparatus of the present invention; FIG. 8D is a schematic diagram of another screen of the operation inspection apparatus of the present invention; FIG. FIG. 8F is a schematic diagram of another screen of the operation inspection instrument of the present invention; FIG. 8G is an operation inspection instrument of the present invention; Another schematic screenshot; FIG. 8H is a schematic diagram of another screen of the operation screen testing equipment of the present invention.

The invention discloses an inspection instrument with quality control judgment and a detection method thereof. By recording the ID data of the operator and the result of the quality control detection in the process of quality control, all the tests can be performed on the patient after the test is passed. Detection, so the detection process method performs automatic judgment and comparison function in each process step, wherein the screen is automatically imported to the next screen, and the operator does not need to test by himself to judge whether the quality control detection has been completed, and not in various modes. Select the switching mode (such as switching to quality control mode or mode for measuring patients).

Referring to FIG. 1 and FIG. 2, the inspection instrument 10 having the quality control judgment of the present invention is applied to a test strip tank 20 and at least one quality control liquid, for example, the first product liquid 21 and/or the second product. The liquid tube 22, and performing the operation of the quality control detection (the operation step is as shown in FIG. 4), the inspection apparatus 10 includes a casing 10a, a screen 11, a scan key 12, a scanning area 13, and an enter key. 14. A return key 15, a switch 16, a test strip slot 17, and a set of numeric keys 18. The screen 11 is disposed on the upper surface of the casing 10a; the scan key 12 is disposed under the screen 11; the scanning area 13 is disposed on the lower side of the casing 10a for scanning the barcode; and the switch 16 is disposed on one side of the casing 10a. For performing the opening or closing of the inspection instrument 10; the test piece slot 17 is provided on one side of the casing 10a. A control circuit 30 (shown in FIG. 3) is disposed in the housing 10a. The control circuit 30 is coupled to the screen 11, the scan key 12, the scanning area 13, and the test strip slot 17 for controlling the operation of the inspection apparatus 10. And performing an alignment of various quality control tests, and determining whether the quality control test passes; the control circuit 30 stores and stores a caregiver ID table (as shown in FIG. 4A) and a test piece correspondence table (as shown in FIG. 4B). And a quality control test results table (as shown in Figure 4C), is the basis for the comparison of the implementation of various quality control tests.

The test strip tank 20, the first product liquid 21 and the second product liquid 22 in Fig. 1 each have a test strip barcode 20a, a first product liquid barcode 21a and a second product liquid barcode 22a. The access key 14, the return key 15, and the numeric keys 18 of FIGS. 1 and 2 are provided on the upper surface of the housing 10a for providing an operator or a caregiver capable of using the enter key 14, the return key 15, and the numeric keys 18 It is convenient to operate the operation of the inspection instrument 10. When the actual application is implemented, the design creator can provide only the enter key 14 and the return key 15, which means that the use of the numeric key 18 is omitted, and the design of the inspection apparatus 10 can be further simplified, and the cost of using the numeric keys 18 can be saved.

Figure 3 illustrates a schematic diagram of the composition of control circuit 30 coupled to peripheral components. The control circuit 30 includes a central operation unit 31, a peripheral interface control circuit 32, and a memory 33. The central operation unit 31 is configured to perform various control actions required by the inspection apparatus 10 during operation detection, such as determining whether the operator is a hospital caregiver or the like, and the control of the step flow as described in FIGS. 5-7 is performed by the central The arithmetic unit 31 performs control. The peripheral interface control circuit 32 is coupled to the central operation unit 31 and coupled to the screen 11, the scan key 12, the scan area 13, the test strip slot 17, the enter key 14, the return key 15, the numeric key 18, and the switch 16, that is, The central operation unit 31 of the control circuit 30 is connected to the screen 11, the scan key 12, the scanning area 13, the test strip slot 17, the enter key 14, the return key 15, the numeric keys 18, and the switch 16 through the peripheral interface control circuit 32 for execution. The relevant control of the instrument 10 is verified. The memory 33 is coupled to the central computing unit 31 for storing the caregiver ID table described in FIG. 4A, the test strip correspondence table of FIG. 4B, and the quality control test result table of FIG. 4C as the basis for the comparison of the test values. .

The caregiver ID table described in FIG. 4A includes fields such as employee number and name, but here is only a brief description. The nurse ID table can be exemplified by two fields, but the actual use is not limited to the above. For the two fields, for example, a third field can be added, and the third field can be used to indicate the department or department to which the caregiver belongs, as a further confirmation of the attributes of the caregiver. The test piece correspondence table described in FIG. 4B includes three fields, such as a test strip barcode, a medical unit, a QC value range, and a quality, for displaying the source identification of the test piece to be taken by the operator, for providing a judgment. Check whether the source of the test piece to be used is a test piece certified by a qualified medical unit. Of course, in actual use, the fifth field can be added to indicate the retention period and other information. The quality control test result table described in FIG. 4C includes four fields including date, QC test value, QC value range, and pass or fail. The “QC” mentioned therein is the name of Quality Control and its meaning. The QC test value is the quality control test value to be tested; the QC value range is the standard value of the QC test stored in advance, and it is possible to judge whether the executed quality control test is performed for the QC test value. Have passed.

Fig. 5 is a view showing a method for detecting an inspection instrument having quality control judgment according to the present invention, which is applied to the apparatus of the above-described inspection apparatus 10, so that the aforementioned test strip tank 20 and at least one quality control liquid are used in combination. For example, there is a first product liquid 21 and/or a second product liquid 22 . The detecting method described in FIG. 5 includes: step S10: booting; receiving step S11: scanning the staff barcode; and performing step S12: determining whether it is a hospital care worker; if not, returning to step S11; if yes, proceeding to step S11; Step S13: Whether the quality control test has been performed on the current day; if not, proceed to step S14: perform quality control detection; if it has already performed quality control detection, proceed to step S17: whether the quality control test has passed; if it passes, proceed Step S16: performing patient measurement; if not, returning to step S14: performing quality control detection; on the other hand, after performing step S14, performing step S15: whether quality control detection is passed; if yes, performing steps S16; if no, return to step S14. This completes the detection method of the inspection instrument with quality control judgment.

The step of determining whether the patient is a caregiver in the step S12 is the data obtained after the barcode of the scanned person is compared with the care stored in the control circuit 30 of the inspection instrument 10 having the quality control judgment. The personnel ID table, if it matches, is judged to be a nursing staff in the hospital. The step of determining whether the quality control detection has passed in step S14 of FIG. 5 can be divided into two partial detections, one of which is a test piece obtained by performing quality control detection (by the test canister 20) The data taken out is compared with the test piece correspondence table stored in the control circuit 30 of the inspection apparatus 10 having the quality control judgment, and if it matches, the test piece passes the test. The other is to perform the quality control test to obtain the product liquid data (taken from the first product liquid 21 or the second product liquid 22), and control the inspection instrument 10 having the quality control judgment. The quality control test result table stored in the circuit 30 is compared, and if it matches, the quality control liquid passes the test.

Another embodiment extended by the present invention, in the process of detecting whether the quality control detection described in the above step 15 is passed, further includes when the operator (ie, the hospital caregiver) finds an abnormal state or does not conform to the When the pre-stored standard is used, the abnormal value measured by the detecting device 10 is uploaded to a remote receiving end, and the receiving end automatically determines that the value is abnormal. Thereafter, the receiving end sends a message to the upper manager of the operator - for example, to the supervisor of the operator, so that this embodiment has the function of monitoring management; at the same time, the operator continues the action of checking the relevant checking. When the quality control test is completed and passed the detection, after the new value is transmitted to the receiving end, the action of the operator is agreed to be performed by the upper manager (the operator's supervisor), thereby achieving the function of monitoring management. purpose.

For further explanation of the execution quality control detection of the above step S14, please refer to FIG. 6, including step S20: performing quality control detection; then performing step S21: scanning the test strip barcode; the scanned test strip barcode 20a, In actual operation, the operator first presses the scan key 12 to make the scanning area 13 emit red light, and then places the test strip barcode 20a in the red light, and the inspection instrument 10 reads the test strip barcode 20a and displays it. In the screen 11, the scanned test strip barcode of step S21 is thus completed. Then, step S22 is performed: scanning the first product liquid bar code; similarly, in this operation, the operator first presses the scan key 12 to make the scanning area 13 emit red light, and then places the first product liquid bar code 21a. In the red light, the inspection instrument 10 reads the first product liquid bar code 20a and displays it in the screen 11, thus completing the scanning of the first quality control liquid bar code in step S22. Step S23: taking a test piece to insert the test instrument; and then performing step S24: dropping the test piece onto the first quality control liquid; then step S25: obtaining a test value, and comparing the quality control test result table, And show whether it passed the test. The method steps of performing the quality control detection are thus completed. The scanning test strip barcode of step S21 includes a comparison table of the result of scanning compared with the test piece stored in the memory 33 of the testing apparatus 10, and if it does not match, the failing detection is displayed.

FIG. 7 is another embodiment of the execution quality control detection related to step S14. The difference from the embodiment of FIG. 6 is that the quality control liquid used in FIG. 7 includes the first quality liquid 21 and the second quality liquid 22 . In practical application, the test value of the first product liquid 21 can be used as an upper limit value of the quality inspection, and the second product liquid 22 is used as a lower limit of the quality inspection, so that it can be formed as a test value. A range for testing the instrument 10 used. The step of FIG. 7 includes S30: performing quality control detection; and then performing step S31: scanning the test strip barcode; then step S32: scanning the first quality liquid barcode; then step S33: taking a first test insert insertion test In the instrument, step S34 is performed: the first test piece is dropped onto the first product liquid; the process proceeds to step S35: the test value of the first test piece is obtained, and the quality control test result table is compared to show whether the process is passed; and then step S36 is performed. : scanning the second product liquid bar code; receiving step S37: taking a second test piece into the inspection instrument; and performing step S38: dropping the second test piece onto the second product liquid; proceeding to step S39: obtaining the second The test value of the test piece is compared with the quality control test result table to show whether it passes. Another embodiment of the method steps of performing quality control detection is thus completed. The scanning test strip barcode of step S31 includes a comparison table of the result of scanning compared with the test piece stored in the memory 33 of the testing apparatus 10, and if it does not match, the failing detection is displayed.

The contents shown in FIGS. 8A to 8H are the screens presented by the step screen 11 described in the above-described FIGS. 5, 6, and 7. FIG. 8A is a display screen of the screen after the step S10 is turned on. In order to prompt the ID of the scanning operator, the operator presses the scan key 12 to align the scanning area 13 with the barcode of the operator's employee identification card, and the inspection instrument. The control circuit 30 of 10 automatically compares the caregiver ID table. If it is determined that the caregiver is in the table, the employee number and name of the caregiver are displayed on the screen 11.

FIG. 8B is a comparison of the execution of step S13 to determine whether the quality control test has been performed on the current day? If it has not been done on the same day, the screen 11 will display the screen as shown in Fig. 8B, and the receiver will enter the next screen as shown in Fig. 8C. FIG. 8C is a screen corresponding to the execution quality control detection described in step S14, S20 or S30, that is, the screen 11 displays the 1-test piece number: 2, the product batch number: and the like, at this time, the operator needs to press The scan key 12 scans the scan area 13 to the test strip barcode 20a to perform scanning. Corresponding to step S21, the control circuit 30 of the inspection apparatus 10 automatically performs the comparison test piece correspondence table, and if it is judged to be qualified in the table. The test strips indicate that there is no problem with the source of the test strips, and if the test passes, the batch number corresponding to the test strip can be correspondingly displayed on the screen 11, and as shown in FIG. 8D. At the same time, FIG. 8D also serves as a quality test for the user to perform the quality control liquid. In response to step S22, the operator needs to press the scan key 12 to align the scan area 13 with the first product liquid bar code 21a to perform scanning. The control circuit 30 of the instrument 10 automatically performs the comparison quality control test result table. If it is judged that it belongs to the qualified QC test value or the QC value range in the table, indicating that there is no problem with the quality control liquid, the test passes, and the screen 11 is displayed. A batch number corresponding to the first product liquid bar code 21a is displayed correspondingly, as shown in FIG. 8E.

On the other hand, in addition to displaying the lot number of the first quality control liquid, the operator is also prompted to insert the test piece, and the test piece corresponding to the step S23 is inserted into the test instrument, and the step S24 is The test piece is dripped on the first product tube liquid, and then the screen shown in Fig. 8F will appear. The space before the indicated mg/dL will display the corresponding value, which can be used as a basis for judging whether or not the test is passed. In addition, FIG. 8G is a corresponding batch number corresponding to FIG. 8E, but is used to express the second product liquid 22 displayed after scanning the second product liquid bar code 22a corresponding to step S36; The operator is prompted to insert the second test piece, and the second test piece corresponding to the step S37 is inserted into the test instrument, and the second test piece is dropped with the second test tube liquid of step S38, and then the figure appears as shown in the figure. In the 8H screen, the space before the mg/dL indicated in the screen will display the corresponding value, which can be used as a basis for judging whether or not the detection is passed.

The above-mentioned inspection instrument 10 having the quality control judgment or the detection method having the quality control judgment can be applied to a bedside inspection instrument (POCT) for detecting blood sugar, and therefore, the present invention can be applied to the existing market. It is used in blood glucose instruments for general use or medical use, and is suitable for blood glucose measuring instruments of various manufacturers. Furthermore, for the testing instrument or device for testing medical body fluids and dripping liquids, the testing instrument 10 with quality control judgment proposed by the present invention or the detecting method with quality control judgment can be used in the detecting instrument. In order to improve the accuracy of medical testing and improve medical quality.

In summary, the present invention provides an inspection instrument with quality control judgment and a detection method thereof. By providing a control circuit 30 in the inspection instrument 10, the control circuit 30 stores a caregiver ID table, a test piece correspondence table, and a quality. Control the test result table, and use it to determine whether it is the nursing staff of the hospital and the detection step of performing the quality control test. It can effectively achieve the test of whether or not the quality control has been performed, and whether the quality control test performed is judged. by. The invention can reduce the setting steps and adjustments of the operator's manual execution quality control, and the invention can not only improve the automatic quality control ability of the bedside inspection instrument, but also effectively improve the efficiency and quality of the medical quality control. It is obvious that the present invention has the requirements for patent application. However, the description of the present invention is merely illustrative of the preferred embodiments, and the scope of the present invention is not limited thereto, and any local variation, modification, or addition is not deviated from the scope of the present invention. in.

Claims (10)

 An inspection instrument having a quality control judgment, which is applied to a test strip tank and at least one quality control liquid, and performs an operation of quality control detection, the inspection apparatus comprising: a casing; a screen disposed on the casing a scanning button disposed under the screen; a scanning area disposed on a lower side of the housing for scanning a barcode; and a test strip slot disposed on one side of the housing; wherein, A control circuit is disposed in the housing, the control circuit is coupled to the screen, the scan key, the scanning area and the test strip slot for controlling the operation of the inspection apparatus and performing comparison of various quality control tests, and The quality control test is judged to be passed; the control circuit stores a caregiver ID table, a test piece correspondence table, and a quality control test result table, and individually serves as a basis for performing the comparison of the various quality control tests.    The inspection instrument of claim 1, wherein the inspection apparatus comprises an access key and a return key on an upper surface of the housing for providing an operator to conveniently operate the inspection. The instrument is provided with a switch disposed on one side of the housing for performing the opening or closing of the inspection instrument.    A detection method for an inspection instrument having a quality control judgment, which is applied to an inspection instrument having quality control judgment as claimed in claim 1, and also for matching the test strip tank and the at least one quality control liquid, wherein the detection method includes : Turn on and scan the staff bar code; determine whether it is the hospital's nursing staff; whether it has done quality control testing on the day; perform quality control test; judge whether the quality control test has passed; and if the quality control test passes, execute the disease The measurement is measured.    The method for detecting an inspection instrument having quality control judgment according to item 3 of claim 3, wherein the step of determining whether the hospital is a nursing staff is the information obtained after the barcode of the scanned person is compared with The caregiver ID table stored in the control circuit of the inspection instrument having the quality control judgment is judged to be a nursing staff in the hospital if they match.    The method for detecting an inspection instrument having quality control judgment according to item 3 of the claim, wherein, after the step of quality control detection has been performed on the day, if it has been done, the quality control test is performed to determine whether the quality control test has passed. If it is passed, the patient's measurement is performed; if it is not passed, the quality control test is performed.    The method for detecting an inspection instrument having a quality control judgment according to Item 3 of the claim, wherein the step of determining whether the quality control detection has passed is a test piece data obtained by performing the quality control detection. The test piece correspondence table stored in the control circuit of the inspection instrument having the quality control judgment, if it matches, the test piece passes the test.    The method for detecting a test instrument having a quality control judgment according to item 3 of the claim, wherein the step of determining whether the quality control test has passed is a product liquid material obtained by performing the quality control test, If the quality control test result table stored in the control circuit of the inspection instrument having the quality control judgment is consistent, the quality control liquid passes the test.    The method for detecting an inspection instrument having quality control judgment according to Item 3 of the claim, wherein the performing quality control detection step comprises: scanning a test strip barcode; scanning a product liquid barcode; taking a test strip insertion The test instrument; the test piece is dropped onto the quality control liquid; and a test value is obtained, compared with the quality control test result table, and whether the test is passed.    The method for detecting an inspection instrument having quality control judgment according to Item 8 of the claim, wherein the performing the quality control detection step comprises: scanning a test strip barcode; scanning a first product liquid barcode; Inserting the first test piece into the test instrument; dropping the first test piece onto the first product liquid; obtaining the test value of the first test piece, comparing the quality control test result table, indicating whether the test is passed; a second product liquid bar code; a second test piece is inserted into the test instrument; the second test piece is dropped onto the second product liquid; and the test value of the second test piece is obtained, and the quality control test result table is compared Whether the passing test is performed; wherein the first product liquid is an upper limit value of the quality control test, and the second product liquid is a lower limit of the quality control test.    The method for detecting an inspection instrument having quality control judgment according to claim 8 or 9, wherein the inspection instrument is a bedside inspection instrument for detecting blood sugar.