HEPCON HEMOSTASIS MANAGEMENT SYSTEM (HMS PLUS)

Transcription

1 Bassett Healthcare Network Point of Care Testing HEPCON HEMOSTASIS MANAGEMENT SYSTEM (HMS PLUS) A. PRINCIPLE The Hepcon HMS PLUS allows for rapid and precise hemostasis control by providing the following information: 1. Indication of heparin response via the heparin dose response (HDR) cartridge. 2. Heparin calculation based on dosing product, patient blood volume, and extracorporeal circuit parameters. 3. Simultaneous, quantitative and functional evaluation of heparin via the heparin assay and HR- ACT cartridges. 4. Calculation of additional heparin required to maintain the patient at an adequate heparin concentration. 5. Calculation of the protamine dose needed to reverse the circulating heparin. A key feature of the Hepcon HMS PLUS is that is provides rapid turnaround of test results with minimal operator interface. An optical code, on each cartridge, instructs the system as to the type of test being performed, the necessary parameters for the calculations and the sample volume required for the test. The operator inserts the appropriate cartridge, and a sample filled syringe into the system starting the test. The HMS PLUS will fill the cartridge and perform the test as instructed by the optical code, on the cartridge. Test results consist of clotting time data, which is displayed on the front panel of the system. Heparin and protamine results are derived from the channel clotting time data of the heparin assay cartridges. The most pertinent results for each test type are automatically displayed at the completion of the test. Secondary calculations and clotting times can be displayed, if desired. B. METHOD The Hepcon HMS PLUS is a microprocessor based, multichannel, clot and timing instrument, with automated syringe handling for pipetting blood into single use cartridges. This integrated system also contains a component for computing the results of the clot detection tracking mechanism. The cartridge instructs the system, through an optical code, as to the type of testing being performed. It also determines calculations and format required and volume of samples needed for each channel. The detection process uses the plunger assembly within the cartridge. This assembly is lifted and dropped through the sample/reagent mixture, by a lifting mechanism, in the HMS PLUS actuator. As the sample clots, a fibrin web forms around the daisy, located on the bottom of the plunger assembly, and impedes the assembly descent rate. This change in fall rate is detected by photocells within the actuator of the instrument. The endpoint of the test is the time at which clot formation is detected. F:/shared/lab/poct/procedures/current procedures/hepcon Page 1 of 13

2 C. REAGENTS AND MATERIALS 1. Hemostasis management system (HMS PLUS) instrument. 2. Cartridges: a. Heparin Assay (HPT) The Heparin Assay Test uses the principle of heparin/protamine titration to quantitatively determine the concentration of heparin in the sample. It is a four or six channel test, with each channel of the cartridge containing a different amount of protamine and a constant amount of thromboplastin, for activation of the test. The first channel to clot is the one in which the amount of protamine most closely neutralizes the heparin in the blood, without an excess of either heparin or protamine. The heparin concentration is used by the HMS PLUS to calculate any additional heparin required to maintain the patient. The data is also used to calculate protamine required for neutralization. The accuracy of the Heparin Assay is dependent on the cartridge channel resolution. This resolution varies from 0.3 to 0.5 mg/kg (0.4u/ml to 0.7 μml) depending on the cartridge range. The determination of heparin concentration by protamine titration remains extremely reliable under conditions of hypothermia, hemodilution and dosing with platelet active drugs. The heparin measurement obtained is considered valid as long as the sample heparin level lies within the range of the selected cartridge. Cartridges are stored either at room temperature (10-25 o C) or refrigerated (2-8 o C) until the manufacturer s expiration date. Expiration dates are on all boxes. The HMS PLUS heparin assay cartridges are designed to give a result in the time frame of seconds. If all four channels clot before 30 seconds, the blood sample may be activated and channel clotting time resolution may not be great enough to give a reliable answer. Run times greater than 300 seconds may indicate the heparin level of the blood was higher than the range of the cartridge, the expiration date has been exceeded, or the cartridge was improperly handled or stored. Due to the USP tolerances of heparin and protamine, test accuracy is typically within ½ channel or 0.34 u/ml. The heparin concentration neutralizing between two channels are likely to clot simultaneously, the HMS PLUS will base results on the more conservative, lower heparin concentration NOTE: DO NOT USE PAST EXPIRATION DATE. The following table indicates the available HPT cartridges and heparin range used at this institution: HEPARIN LEVEL Cartridge CH1 CH2 CH3 CH4 CH5 CH6 Red mg/kg Gold mg/kg Orange mg/kg F:/shared/lab/poct/procedures/current procedures/hepcon Page 2 of 13

3 b. Activated Clotting Time (HR-ACT) The high range ACT is a functional evaluation of the intrinsic coagulation system. It is used to monitor the anticoagulant effect of heparin. Clotting is initiated by surface contact by an activator (in this case, kaolin). The activator provides consistent results by optimizing activation of Factor XII. The test responds linearly to heparin concentrations. The HR-ACT is a two-channel cartridge and the end point to the test is the detection of clot formation. Each cartridge reagent chamber contains 0.1 ml of kaolin suspended in HEPES buffer, calcium and sodium azide as a bacteriostatic agent. NOTE: DO NOT USE PAST EXPIRATION DATE. c. Heparin Dose Response (HDR) The HDR cartridge is a modification of an activated clotting time (ACT). The test is based on the in vivo to help identify patients who may be unusually sensitive or resistant to heparin anticoagulation. Each cartridge reagent chamber contains 88 microliters of HR-ACT reagent (kaolin, calcium in a HEPES buffer and sodium azide). Channels 1 and 2 contain USP beef lung heparin at a concentration which gives 2.5 units of anticoagulant activity per ml of blood while channels 3 and 4 contain heparin at a concentration which gives 1.5 units of anticoagulation activity per ml of blood. Channels 5 and 6 do not contain heparin. It is important to shake or tap cartridge before inserting into instrument to resuspend cartridge reagents. Cartridges are stored either at room temperature (10-25 o C) or refrigerated (2-8 C) until the manufacturer s expiration date. Expiration dates are on all boxes. NOTE: DO NOT USE PAST EXPIRATION DATE. Cartridge CH1 CH2 CH3 CH4 CH5 CH6 Red White Stripe μ/ml 3. Limitations: a. HR-ACT Cartridge: When on bypass, several factors can influence the performance of the HR-ACT. These include: patient sensitivity to heparin, dilution of the clotting factors by the extracorporeal circuit, use of citrated blood products, use of antiplatelet drugs, hypothermia, fluctuating calcium levels, a change in platelet function or count and unknown coagulopathies. These factors must be taken into consideration when evaluating the performance of the ACT during bypass. HMS PLUS HR-ACT cartridges, in the clotting range of seconds, typically do not exceed a variation of +/- 12% of the average of the cartridge channels. At high heparin levels and clotting times in excess of 600 seconds, an ACT is generally not considered to be adequately reliable for monitoring heparin anticoagulation. The cartridge is controlled to maintain an average population response of approximately 100 seconds per unit of heparin (136 sec/mg/kg heparin). The baseline range of a controlled group of the ten average donors gave a mean baseline of 117 seconds (2SD = 18 sec.). F:/shared/lab/poct/procedures/current procedures/hepcon Page 3 of 13

4 b. HDR Cartridge: Individual responses to heparin vary considerably. An in vitro test measures only variables present in the whole blood sample, which contribute to variations in response to heparin, and cannot measure all in vivo variables. Therefore, it is important that all technique variables be held consistent from test to test. The HDR cartridge is controlled to maintain an average response of approximately 100 seconds per unit of heparin. The clotting times from a group of 10 average donors have a mean 2.5 u/ml time of 306 seconds (2 S.D. = 62 seconds) and a mean 1.5 u/ml time of 213 seconds (2 S.D. = 34 seconds). The HDR cartridges typically do not exceed a variation of +/- 12% of the average of the paired channels (channels 1 and 2, channels 3 and 4). During patient diagnosis, any medications should be noted. Medications and conditions can alter clotting times. c. All Cartridges: Any of the cartridges (HPT, HR-ACT and HDR) should be repeated when unexplained abnormal values are obtained. If the results are still abnormal, and no cause apparent, a sample can be citrated and saved for further analysis in the clinical laboratory. D. SPECIMEN REQUIREMENTS Whole blood via the patient s arterial or venous blood line. A 2-3 cc discard syringe should be used in order to obtain a clean draw sample. Use only 3 cc Monoject syringes, and 19 gauge blunt needles, provided by Medtronic HemoTec, Inc. If blood is obtained by venipuncture, the site should be clean and the first several milliliters of blood discarded to avoid contamination of the sample, with tissue thromboplastin. Samples taken from heparinized in-dwelling catheters, or other anticoagulated lines, should be thoroughly flushed so that a sample can be drawn that is representative of the patient. Samples should be run within 60 seconds for un-heparinized samples and 2 minutes for heparinized samples. E. PROCEDURE 1. Pre-analytical Steps: a. Prior to running the patient sample, certain default parameters are entered into the HMS PLUS. Other default parameters can be entered into the HMS PLUS instrument. They are as follows: Patient MR # or Visit # (required) Patient Height. Enter in feet and inches, or in centimeters (ex is 180 cm). Patient weight. Enter weight in lbs or in kgs (ex. 176 lbs is 80.0 kg). Sex of patient. Enter M (male) or F (female). When pressing the PAT VOL button, one can obtain patient blood volume and the patient s BSA (body surface area). b. Verify the heat block temperature is at 37.0 C + \ C (press the C button). c. Syringe insertion is very important to the success of the test. Follow these guidelines: F:/shared/lab/poct/procedures/current procedures/hepcon Page 4 of 13

5 Draw the appropriate amount of sample into the 3.0cc syringe, attach and prime the needle. Insert the sample filled syringe into the dispenser by sliding the needle through the keyhole slot, so the hub of the needle is on the syringe holder foot. Rotate the syringe until the cross-member of the syringe plunger is parallel to the face of the syringe holder. Press the syringe body into the syringe holder, insuring that the cross-member is positioned between the drive wheel and the syringe clamp. Push the syringe lock-lever down to hold the syringe in the holder. Upon completion of the test, remove the syringe, then the cartridge(s), and dispose of them in an appropriate hazardous waste container. 2. Testing Procedure: a. HDR test - Start from MAIN MENU Screen: To set up the screen mode, press Instrument Parameters. (This does not have to be entered each time a new patient sample is run.) Place an HDR cartridge into the heat block, (Important: Shake or Tap cartridge to resuspend cartridge reagents) and allow prewarming for at least three minutes prior to drawing the sample. Verify that the correct patient and protocol parameters have been entered. Draw a full 3 cc of sample into the syringe and attach the needle. Fill the needle with the sample. Insert the needle/syringe into the dispenser of the HMS PLUS and press the START/STOP to initiate the test. The HMS PLUS will go into the REQ mode. TOT will be illuminated and the running time will be shown in the test time displays window. When the test is finished, the test time result will show the average baseline clotting time. Also, a printout of the results of the HDR test will automatically be sent out from the instrument. Record these parameters on the patient s heparin management record. The system will display the patient s estimated reference heparin concentration for the desired clotting time (REF HDR), which is >480 seconds. The HDR test will print and/or display an HDR PROJ (HDR projection). This is the patient s individual sensitivity to heparin, and this mg/kg dose may be less than, or greater than the standard mg/kg guideline. Press PRINT to display a new printout of the projected clotting range and enter this on the patient s heparin management record. At this time, the HMS PLUS can compute a bolus dose of heparin for the patient. Either a predetermined amount of heparin can be entered, or the heparin prime dose may be entered as O, therefore, the HMS PLUS does not take any heparin into account when computing the patient dose. In order to obtain the amount of heparin to be added to the pump, simply press BOL and the heparin amount will be displayed. By pressing the PAT key, the loading dose of heparin to be given (by the surgeon) will be displayed for this patient. Also, by pressing TOT, the total amount of heparin the patient will receive will be displayed. All three of these parameters should be entered on the patient s heparin management record. Error or precautionary conditions associated with the HDR test can be self diagnosed by the HMS PLUS. If any such conditions occur, a message will appear in the message display prior to calculation of results. F:/shared/lab/poct/procedures/current procedures/hepcon Page 5 of 13

6 Error and precautionary messages are discussed in Section 9 (Service and Troubleshooting), in the Hepcon HMS PLUS Operator s Manual/Quality Control Logbook. If the difference between any channel pair is greater than +/- 12%, CHECK TIMES CH XX will appear on the message display and indicate the channel pairs that are out of specification. Inappropriate channel clotting times can be edited and the results recalculated. Refer to EDIT instructions in the operator s manual. b. Heparin Assay and HR-ACT Tests After the heparin has been given and allowed to circulate for 3-5 minutes, verify concentration and effect by running a heparin assay and HR-ACT cartridge. Heparin assay cartridges are selected based on the desired protocol. The desired heparin concentration to maintain the patient (REF CONC) should correspond to the third or fourth channel of a 4 channel cartridge or the fourth, fifth, or sixth channel of a 6 channel cartridge. For example, if the projected heparin concentration is 2.0 mg/kg, select a heparin assay cartridge where 2.0 concentration is the Ch 3 or 4 of a 4 CH cartridge or Ch 4, 5, or 6 of a 6 CH cartridge. The test is considered valid only if the test results lie within the range of the selected cartridge. Place the HR-ACT and appropriate heparin assay cartridge into the heatblock and allow both to prewarm for at least three minutes prior to drawing the sample. This initial test should be run within the first 5-10 minutes before going on bypass. Draw approximately 3 cc of sample into the syringe (at least 2.5 cc are needed for heparin assay and HR-ACT). Prime the needle with the sample. Insert the needle/syringe into the dispenser of the HMS PLUS and press START/STOP to initiate the test. The HMS PLUS will go into the REQ mode. TOT will be illuminated and the running time will be shown in the TEST TIME display. While on bypass, verify heparin concentration and effect by running a heparin assay (HPT) and HR-ACT cartridge every 30 minutes. Give additional heparin at our discretion if the HR-ACT result is less than the desired clotting time. Use the HEPARIN unit s display as a guide for the amount of heparin to give in order to stay above target ACT. Precaution: Patients with varying metabolic rates may require more frequent testing, accompanied by heparin additions to maintain safe anticoagulation. If the run time for the heparin assay is greater than 249 seconds, the test is not considered valid. The message display will indicate HPT RUN TIME GREATER THAN 249 SEC. A warning condition will appear on the printout. c. Protamine Reversal Just prior to coming off bypass, perform a heparin assay and HR-ACT to determine heparin concentration for calculation of protamine dosage. Before, during, or after the test is initiated, press PROT for the protramine neutralization mode. In this mode, PAT will be illuminated. Place the appropriate heparin assay and HR-ACT cartridge into the heat block and allow at least three minutes prewarming. Draw about 3 cc of sample into the syringe and attach the needle. Fill the needle with sample. F:/shared/lab/poct/procedures/current procedures/hepcon Page 6 of 13

7 Insert the needle/syringe into the dispenser of the HMS PLUS and press START/STOP to initiate the test. The amount of protamine for the patient will be displayed in the PROTAMINE window. Pump protamine can also be displayed if blood is given back to the patient. In the PROT mode, printouts show TOT, PAT, or PMP protamine as well as cartridge and reference information. Once off bypass, report the protamine dose to be given to the patient. After the protamine has been slowly administered and allowed to circulate for ten minutes, verify neutralization by performing a low range heparin assay (red cartridge) and HR-ACT. If bleeding occurs and heparin assay indicates additional protamine is needed, report dose to the surgeon and anesthesia staff. Repeat step 8 until no additional protamine is indicated. If bleeding still occurs, discuss with the surgeon the possibility of a mechanical bleeding site, or if there is an indication of further coagulation tests needed, since bleeding could be the result of diluted or deficient clotting factors, or thrombocytopenia (low platelet count). F. RESULTS REPORTING 1. Reference Values a. Heparin Assay (HPT) mg. b. HR-ACT The expected normal values for the HR-ACT, the baseline range of a controlled group of twenty average donors drawn in-house gave a mean baseline of 125 seconds with a range seconds (2 standard deviations). The therapeutic range is >480 seconds. 2. Patient Results a. Patient results are printed on the instrument s printer tape. Printer tape is retained for one year and is not a permanent record. b. Patient results are recorded on the perfusion record. The white copy is kept in the patient s medical record. The yellow copy is the department copy, and the pink copy is the perfusionist s record. Patient results are archived for seven years. G. MAINTENANCE 1. Routine Cleaning Routine cleaning must be performed every day of testing. The instrument case and exposed surfaces of the actuator and dispenser should be kept clean. Clean the case routinely by wiping off dirt and dried blood with a cloth dampened with water or one of the following chemicals: isopropyl alcohol, Methanol, propyl alcohol, glutaraldehyde, bleach, ethanol, Liqui-Nox, parachlorometaxylenol, hydrogen peroxide, betadine, saline, or a mild detergent. The HMB cleaning kit can be used to clean difficult to reach areas in the dispenser. Cleaning kits can be used to clean difficult to reach areas in the dispenser. F:/shared/lab/poct/procedures/current procedures/hepcon Page 7 of 13

8 Cleaning kits can be obtained from Medtronic Customer Service. The salvage reservoir, located in the notched plate under the dispenser, is designated to catch any residual blood from the needle. The disposable reservoir should be changed daily, or as required (between patients). 2. Verification of Heat Block Temperature The temperature of the heat block must be verified once a month to insure that the heat block is maintaining C. The Medtronic blood management temperature verification thermometer will be required. Results of the verification are documented on the monthly log. a. If the HMS PLUS is not already left in the on mode, turn the instrument on and allow minutes for it to warm up. NOTE: The instrument s heat block temperature must be between 35 C - 39 C for temperature adjustments to be made. If adjustments are attempted and heat block temperature is not in this range, the screen s Status Message area will indicate this condition with a display message. b. The HMB PLUS must be in the Main Menu screen to begin temperature verification. c. Next choose Quality Control Menu. d. From the Quality Control Menu choose Temperature Adjustment variable function key to display the TEMPERATURE ADJUSTMENT screen. Instrument Temperature and Temperature Reading will appear on the screen, both showing the instrument current temperature value. The Temperature Reading value will be flashing in inverse video. e. Next turn on the Temperature Verification Thermometer. Press and hold the power switch located on the front of the thermometer. The displays should read E indicating that the thermometer is functioning. Release the button. The displays will blink L C. Insert the thermometer into the heat block of the instrument. Once the thermometer of the heat block is reached, the C symbol will stop blinking and a beeper will sound. f. Read the temperature from the temperature verification thermometer. The instrument and the actual measured temperature should both read within 36.5 C 37.5 C range. g. If the measured temperature is not the same as the Instrument Temperature displayed, the measured value can be entered with the numeric keypad. The Enter key must be pressed to accept the value. NOTE: If the displayed instrument is not adjusted, simply press Cancel key to retain the current value. h. If the measured temperature is not between 36.5 C 37.5 C, contact Medtronic Technical Service or an authorized representative. i. If desired, the test may be repeated by pressing the Repeat Adjustment variable function key. The Exit to Quality Control Menu variable function key can be pressed to return to the QUALITY CONTROL (QC) MENU Screen. NOTE: If the Temperature Reading is active (flashing in inverse video), the value must be adjusted or canceled per step 7 above before the exit variable function key is enabled. F:/shared/lab/poct/procedures/current procedures/hepcon Page 8 of 13

9 j. Turn off Thermometer by pressing the power switch again. The thermometer will automatically shut off after approximately 8 minutes. Thermometer Specifications Range Accuracy* Battery Power Consumption Battery Life 32 C 42 C C between 34 C - 40 C One 1.55V button size battery (SR41, VCC392, or LR41) 0.15 milliwatts in measurement mode More than 200 hours of continuous operation NOTE: Tested and accepted by Medtronic Blood Management using calibrated standards traceable to N.I.S.T. (National Institute of Standards and Technology). See manufacturer s insert for battery replacement instructions. 3. Verification of Dispenser Volume Delivery The volume delivery by the HMS PLUS dispenser mechanism must be verified once a month and documented on the monthly log. a. The HMB PLUS must be in the Main Menu screen to begin verifying dispenser volume delivery. b. Next choose Quality Control Menu. c. From the Quality Control (QC) menu screen, press the Verify Dispenser Volume Delivery variable function key to display the first dispenser volume delivery verification screen. There are three (3) screens displays during this procedure. d. Pull back the plunger of an empty 3 cc Monoject syringe to the 2 cc mark, and insert the syringe into the syringe holder, (with measurement markings facing forward) as if preparing to run a test. e. Press the Start/Stop key as instructed on the screen. The syringe holder will move to the left and the second screen will appear with the message Delivering 1 ml in flashing in inverse video. NOTE: If the syringe is not locked in place when the Start/Stop key is pressed, the screen s Status Message area will indicate this condition with a display message. f. When dispensing is complete, the third screen will appear. The dispenser should move the syringe plunger from the 2 cc (ml) mark to the 1 cc (ml) mark. Verify that the plunger has been moved to within 0.1 cc (one graduation mark) of the 1 cc (ml) line. If the appropriate volume is not dispensed, contact Medtronic Technical Service or an authorized representative. g. If desired, the test may be repeated by pressing the Repeat 1ml delivery variable function key. The dispenser volume delivery verification screen will reappear. The Exit to Quality Control Menu variable function key, which appears on all three screens, can be pressed to return to the QUALITY CONTROL (QC) MENU screen. F:/shared/lab/poct/procedures/current procedures/hepcon Page 9 of 13

10 NOTE: If this key is pressed once delivery has started but not finished, the test is incomplete. The test will also be incomplete if the START/STOP key is pressed before delivery has finished. 4. Installing Printer Paper The HMS PLUS internal paper requires thermal printer paper than can be ordered from Medtronic Customer service or an authorized representative. To install printer paper, refer to figure located inside printer access panel. a. Open the printer access panel using the notch provided near the top right side of panel. b. Insert a new roll of paper into the paper tray as shown, such that the paper rolls out from the bottom of the tray rather than the top. c. Feed paper end through the back of the roller, then press the Paper Advance key one time to forward the paper through the printer. d. Raise and lower the tension lever on the right of the printer, as viewed from the front, in order to reset the system. e. Press the Paper Advance key to advance the paper as necessary. f. Replace the access panel. 5. Fuse Replacement a. Turn the HMB PLUS instrument s power switch to the OFF position. b. Disconnect power cord. c. Locate the fuse holder on the instrument s back panel. d. Remove the fuse holder using a small, flat-blade screwdriver or similar tool (the fuse has a notch on its top edge). e. Remove the fuse(s) from the holder and inspect. Replace as necessary with the correct type and rating fuse(s). NOTE: The fuse holder contains two (2) #:T4A 25OV ( / ). Appropriate replacements are available from Medtronic. f. Replace the fuse holder, orienting it so the two hooked, locking tabs are facing up. g. Snap the holder securely in place to lock. H. QUALITY CONTROL 1. HEPtrac Electronic Quality Control (EQC) a. Principles of Operation The HEPtrac Electronic Quality Control is utilized in integrated systems, such as the HMB, which use the hemostasis management cartridge for hemostasis management. The HEPtrac is an interactive mechanical and software controlled verification cartridge that includes both quantitative and qualitative results. The purpose of the HEPtrac is to provide a means for performing quality control of the instruments in the clinical testing environment. Using the electromechanical and software aspects of the HMS, the HEPtrac checks the following F:/shared/lab/poct/procedures/current procedures/hepcon Page 10 of 13

11 aspects of the HMS that relate to the proper cartridge functioning: flag sensor function, reagent delivery, flat release force, flag height and clotting time ranges. The HEPtrac can also identify instruments that are no longer in calibration. HEPtrac EQC must be performed EVERY EIGHT HOURS of patient testing and documented on the EQC log. The HEPtrac checks the following aspects of the HMS that relate to proper functioning of the test cartridge: Flag Sensor Function The HEPtrac checks flag sensor function for all channels by energizing the flag sensor LED s and looking for a Sensors on signal. Results are recorded on the HMS printout. Reagent Delivery The HEPtrac checks the function of reagent delivery push rods for all channels by energizing the flag sensor LED s and moving the reagent delivery push to a target position. The HMS push rods move the HEPtrac flags to a position where the flags block the instruments flag sensors. This action produces a Sensors Off signal at a known position. Results are recorded on the HMS printout. Flag Release Force The Heptrac checks the flag release force of the HMS lift wire. A known amount of force is required to lift the HEPtrac flags. The HEPtrac flags are subject to a series of lift wire force, which are described as ramps. The force of the lift wire increases with increasing ramps. Results are recorded on the HMS printout. Flag Height The HEPtrac checks flag height adjustments for all channels by energizing the flag sensor LED s and moving the flag lift wire through a series of step positions. The HEPtrac flag block the instrument flag sensors producing a Sensors Off signal at a known step position. Results are recorded on the HMS printout. Clotting Time Range-Levels 1,2,3, and 4 Testing The HEPtrac checks four range levels of emulated clot detect times for all channels by actuating the lift wire. The flags are then held up in a clot detect mode. This check is performed for four known clotting time range levels. These range levels represent various cartridge clotting time results; the results are recorded on the HMS printout. The clotting time range levels include: Level 1: seconds Level 2: seconds Level 3: seconds Level 4: seconds b. Conducting HEPtrac EQC Test Place the HEPtrac in the HMS. Press the Start/Stop or Cont key to initiate the test. The HMS message panel will display HEPtrac Electronic QC upon test initiation. After completing the test (approximately 10 minutes), the HMS sounds an audible tone and the results automatically printout. Check the printed test results. F:/shared/lab/poct/procedures/current procedures/hepcon Page 11 of 13

12 If any failures occur, the HMS printout will print the failure(s) and the statement QC Test Aborted. Repeat the test. If the results still produce failures, contact Medtronic Blood Management Technical Service Department. 2. Hepcon HMS Plus and CLOTtrac HR Controls Hepcon HMS PLUS controls enable users of the Hepcon HMS PLUS coagulation instrument to verify the performance of the instrument and the respective Heparin Assay or ACT cartridges. a. HMS Heparin Assay Control - for heparin assay level cartridges (from fresh sheep s plasma and USP referenced beef lung heparin). HMS PLUS red/yellow cartridge (contains 1.4 u/ml heparin, serves as low-end control). HMS PLUS tan/silver cartridge (contains 4.1 u/ml heparin, serves as high-end control). 3 cc Monoject syringes and 19 gauge blunt needles. Remove the Heparin Assay control and deionized water vials from the refrigerator and allow warming to room temperature, approximately 10 min. Add 2.5 cc of deionized water packaged with the controls to each vial. DO NOT AGITATE the control until completely hydrated. Allow to rehydrate for at least three minutes. Swirl gently to thoroughly rehydrate the control. Insert the Heparin Assay cartridge in the HMS PLUS. Press cont to put system into the CONTROL MODE. The instrument will verify the appropriate control to be used. Fill a syringe with control and prime the needle. Place this control into the dispenser. The system will instruct you to press cont, and will fill the Heparin Assay cartridge. When the test is complete, the detected concentration will be shown in the Heparin CONC display. Verify that the required Heparin Assay channel detects, and the run time is within the limits stated in the package insert. The insert is located in the HMS PLUS Operator s Manual/Quality Control Log book. Record result on Quality Assurance Record. b. CLOTtrac HR Control - for ACT Cartridges Liquid controls are run with each new lot and/or shipment of cartridges. Remove the CLOTtrac HR coagulation control and deionized water vials from the refrigerator and allow warming to room temperature, approximately 10 minutes. To the lyopholized whole sheep s blood, add 1.8 ml of deionized water. DO NOT AGITATE THE CONTROL UNTIL COMPLETELY REHYDRATED. Allow at least 10 minutes for adequate rehydration. Once rehydrated, shake the control vigorously until the red blood cells are uniformly dispersed and the control is completely reconstituted. Shake or tap the cartridge to re-suspend the cartridge reagents, and insert into the machine. Press cont to initiate the CONTROL MODE. Fill a syringe with the reconstituted control and prime the needle. Place the filled syringe, with needle, into the dispenser. Press cont again, as instructed by the HMS PLUS, to initiate the test. When the test is complete, the average clotting time for the HR_ACT will be shown in the TEST TIME display. Verify the clotting time is within the range stated in the package F:/shared/lab/poct/procedures/current procedures/hepcon Page 12 of 13

13 insert. (Insert is in the HMS PLUS Operator s Manual/ Quality Control Log book). Record results on Quality Assurance Record. c. If QC fails: Re-run QC If still out, open new QC material If still out, try new cartridge lot If still out, notify manufacturer If still out, use i-stat until resolved I. TROUBLESHOOTING Refer to Medtronic HMS Plus operator manual and/or call technical service assistance at: J. REFERENCES 1. All reference material noted for this procedure can be found in Section 10 of the HMS PLUS 2. Operator s Manual/Quality Control Logbook located in each of our open-heart operating rooms. 3. HMS Plus Operator s Manual. (Medtronic, Inc., 1998) 4. HMS Plus Quality Control Log Book. 5. Heptrac Electronic Quality Control Operator s Manual, Medtronics, Inc F:/shared/lab/poct/procedures/current procedures/hepcon Page 13 of 13