ITC Hemochron Signature Elite

Transcription

1 ITC Hemochron Signature Elite The HEMOCHRON Signature Elite Whole Blood Microcoagulation System provides a patented clot detection system. The system measures whole blood clotting times using HEMOCHRON Jr. disposable single-use cuvettes.

2 Objectives Discuss requirements for the test, reagent preparation and storage and samples Review Quality Control Procedures Review Patient Testing Procedures Review Result Entry Results Review, Interpretation and Actions Discuss limitations of test cuvettes Review Basic Troubleshooting Steps

3 Test System The HEMOCHRON Signature Elite Whole Blood Microcoagulation System: Battery-operated, hand-held instrument that performs individual pointof-care coagulation tests on fresh whole blood including: Activated Clotting Time for the monitoring of heparin anticoagualtion ACT+: High Range ACT-LR: Low Range

4 Instrumentation: Test chamber: warms test cuvette, and performs all operations to measure the clotting time of a whole blood sample. Operator instructions and completed test results are shown on the display panel The operator enters commands information using the keypad. Results are stored in system memory for printing or downloading The instrument includes a barcode scanner. The front panel contains a keypad with various action keys as well as a number pad. Action keys display a menu of commands according to the label on the key. For example, the PRINT/SCAN key displays printing commands and enables scanning. Number pad (or option) keys are used to enter characters for IDs or numbers for selection of commands. Note: The 0 (zero) key is used as both a numeral key and an action key 4

5 Reagents Tests are performed with singleuse disposable HEMOCHRON Jr. test cuvettes. Each test cuvette contains: A label, A sample well, A test channel containing reagents An enclosed waste reservoir One or more optical detection windows. The cuvette label is automatically read by the instrument and displayed for confirmation when the operator inserts the cuvette into the test chamber Unopened test cuvettes may be stored at room temperature for up to 12 weeks. Pouches must be re-dated to indicated the new expiration date. In no case shall the expiration date exceed that printed on the pouch by the manufacturer 5

6 Sample Fresh whole blood should be used for testing. Any specimen contaminated with tissue thromboplastin, indwelling i.v. solution, alcohol cleansing solution or visible clotting and/or debris accumulation should be discarded immediately 6

7 Quality Control Electronic QC - Manual 2 levels and Temperature Verification must be tested every 8 hours when in use for patient testing. To perform EQC press QC key and then press #1. Liquid QC 2 levels must be tested each time a new box of test cuvettes is opened or at least once a week When refrigerated (2 8 C) the vials are stable until the marked expiration date Reconstituted vials should be used immediately Quality Control products may also be stored at room temperature for up to 4 weeks (28 days) The quality control product should never be exposed to temperatures in excess of 37 C The marked expiration date must not be exceeded A re-dating label is provided and should be marked with 4 weeks dating if room temperature storage is selected. 7

8 Electronic QC (EQC) - Automatic Automatic EQC is the preferred method for ensuring the QC is performed without impeding patient testing. If the instrument is set up properly, it will automatically run both levels of EQC and the Temperature check, every 8 hours. The Elite must be kept plugged and turned on at all times for Auto-EQC to initiate. Note - the Elite will immediately begin EQC if instrument was unplugged and then turned on. 8

9 Performing Electronic QC (EQC) Display the QC Status menu by pressing the QC key before a cuvette is inserted. If EQC is run while a cuvette is inserted, the message Detector Blocked is displayed and the EQC test fails. Press 1. The test chamber warms to temperature and the EQC test begins. Results are displayed while the test is progressing. When the test is completed, the results are displayed on the screen and written to the QC Database Press CANCEL to exit the screen. Note: Internal EQC will check two levels of QC and the temperature, and it will store each result. If one result fails, the test will stop and record all results as failed. If the user aborts the internal EQC test, the test is not saved to the database. 9

10 Liquid QC (LQC) To run or check QC status when it is not required, press the QC key. Select QC NORMAL (or QC ABNORMAL) and scan an Operator ID for the test. Important: LQC results will be stored in the patient database if QC NORMAL or QC ABNORMAL is not selected for the test. Obtain the liquid quality control products. Obtain a cuvette for the test to be validated and insert it into the instrument. 10

11 LQC continued The prompt to enter cuvette and QC lot number is automatically displayed when a QC test is selected: position the scanner port approximately four inches from the barcode and press PRINT/SCAN. When Add Sample and Press Start are displayed, add the appropriate liquid control sample Note: If any error messages appear on the instrument screen, remove the cuvette and repeat the test using a new cuvette. Acceptable performance ranges for the HEMOCHRON Jr. cuvettes are included with each HEMOCHRON QC product. Once cuvette and control information has been accepted a 5 minute count down will begin. Add QC material prior to the countdown expiring. 11

12 Running LQC To reconstitute control tap control on a flat surface Using the protective sleeve, crush the top, bottom and middle of the control using the edge of a table Rotate the control 45 degrees and crush the top, bottom and middle again. Snap the wrist 10 times to mix the control material Discard the first drop of control into the cap Add sample to the sample well Press and hold the start key 12

13 Starting the TEST Fill the sample well from the bottom up. Add enough blood or QC material so that the lower wall of the center sample well is completely filled. If the meniscus of the sample extends above the wall, push the excess sample into the overflow area. Press the START key. The elapsed time (in seconds) is displayed until the sample clots. SAMPLE TOO SMALL, SAMPLE TOO LARGE, or SAMPLE NOT SEEN is displayed if an incorrect amount of sample was added. Repeat the test using a new cuvette. When a clot is detected, the instrument beeps once. Final results of the test are calculated and displayed. Remove the cuvette and discard it. Results are saved in the database the date and time of the test, cuvette lot and/or QC lot information, PID, OID, note(s) (if entered), and error message (if a fault is detected for the test or sample) are printed with the test result The cause of out-of-range results is likely attributable to test technique, control material, cuvette and/or the instrument. 13

14 Patient Test Insert a cuvette with the label facing up. Push it all the way in until it stops. Enter the Operator ID (OID) by scanning the barcode on ID badge and then the Patient ID (PID) by scanning the patient s wrist band. When the test cuvette reaches 37.0 C ±1.0 C, the instrument will beep. The "Add Sample" "Press Start" messages are displayed and a 5-minute window allows you to: Acquire the sample, Fill the sample well and Press "START" Do not obtain the blood sample until the instrument displays the message "Add Sample" and "Press Start" or the fresh whole blood sample will begin to clot Fill the sample well from the bottom up so the lower wall of the sample well is completely filled. If the blood sample extends above the lower wall, push the excess blood into the overflow area. Press the "START" key, the elapsed time is displayed in seconds until the sample clots. When a clot is detected, the instrument beeps and final results of the test are displayed. Record results in the patient's electronic medical record 14

15 Result Entry Report all results electronically and/or on the patient s flow chart, Perfusion Record, or Sheath Pull sheet. Results in the Cath Lab are verbally communicated and then added to the patient s record. Report results to Provider as per Nursing policy. To enter results electronically: RN PowerChart Sign-On Chart Ad Hoc Charting Assessment/Intervention Point of Care Testing Miscellaneous Fill out all required fields Click checkmark on top left to SIGN and close form 15

16 Results Review, Interpretations and Actions The Reporting range of ACT+: seconds. The Reporting Range of ACT-LR: seconds. Test results <68 for ACT+ or <65 for ACT-LR will display an Out-of-Range-Lo error message. This may indicate excessive blood coagulation activation and should be repeated to confirm. Test results >1005 for ACT+ or >400 for ACT-LR will display an Out-of-Range-Hi error message. This may indicate excessive blood anticoagulation and should be repeated to confirm. Results that appear to be inconsistent with patient therapy should be viewed as questionable and should be repeated. Normal Population: sec. Please follow hospital protocols and standards for anticoagulation therapy during any procedure in which ACT testing is performed. 16

17 Test Limitations Test results of the HEMOCHRON Signature Elite Microcoagulation instrument are affected by poor technique during blood collection and delivery to the sample well. The accuracy of the test is largely dependent upon the quality of the blood specimen, which is dependent upon the blood sample collection and the transfer of blood to the test cuvette. HEMOCHRON Signature Elite test results should always be scrutinized in light of a specific patient s condition or anticoagulant therapy. Any test results exhibiting inconsistency with the patient s clinical status should be repeated or supplemented with additional diagnostic tests. Samples with a hematocrit less than 20% or greater than 55% are not recommended, due to an optical density outside the detection level of the HEMOCHRON Signature Elite Microcoagulation instrument. 17

18 Summary Discuss requirements for the test, reagent preparation and storage and samples Review Quality Control Procedures Review Patient Testing Procedures Review Result Entry Results Review, Interpretation and Actions Discuss limitations of test cuvettes Review Basic Troubleshooting Steps

19 Please take the quiz. 19