Written by: Paul Pappagianopoulos Date: 6/01/2005

Transcription

1 Title: GEM 3500 Procedure Cross References: GEM 3500 Competency Documentation-6 month and Annual GEM 3500 Training Quiz GEM 3500 Corrective Action Log MGH POCT Inter-Laboratory Correlation Procedure MGH POCT QC Storage Ordering and Documentation Guide POCT Proficiency Testing Procedure POCT Proficiency Testing Evaluation Worksheet POCT Program Massachusetts General Hospital - Pathology Service 55 Fruit Street, Boston, MA Contents: Purpose... 2 Scope... 2 Policy and Procedure Statement... 2 Proficiency Testing... 2 Regulatory Requirements... 3 Competency Assessment... 3 Limitations and Interferences... 4 Test Kit/Supplies/Equipment... 5 Quality Control and Calibration... 5 Calibration Verification / PVP... 8 Specimen Collection... 8 Patient Test Procedure Result Reporting Reference Values Instrument Maintenance Technical Support References Written by: Paul Pappagianopoulos Date: 6/01/2005 1

2 Purpose This document outlines policies and procedures that deal with blood gas and lactate testing on the GEM In an effort to be concise some information may be excluded from the manufacturer s recommended procedure. It is recommended that operators familiarize themselves with the manufacturer s product information that accompanies each package and their manual if one exists. Scope Testing site: The Pulmonary and Critical Care Laboratory Level of Personnel: Pulmonary Technologists Policy and Procedure Statement The GEM Premier 3500 analyzer is a portable critical care system to rapidly analyze whole blood samples. The instrument provides quantitative measurements for ph, pco 2, po 2, and lactate. These parameters, along with derived values, aid in the definitive diagnosis of a patient s acid/base status and metabolite balance. Proficiency Testing The College of American Pathologists (CAP) sends unknown samples to the laboratory for analysis several times per year. Results are submitted to the CAP within 10 days of survey receipt. If a site fails 2 out of 3 events or two consecutive events, according to federal law, it may be required to discontinue testing. All Survey results are to be handled and reported in the same manner as clinical results following the directions on the CAP Survey package insert. The samples are not to be analyzed in duplicate unless clinical specimens are analyzed in duplicate. Actions or decisions must be documented. Participation must be random and not assigned to specific individuals. Successful participation may be used as demonstrating successful competency for that year. Upon receiving the survey: The POCT program will contact the participating departments regarding the survey and the timeline of the survey to be performed. The departments must be available within the period identified by POCT. The Key operators must make sure of the following: o o o o o Instruments are in good working order. Randomly select staff to participate. Maintain original CAP survey form with the results documented. Maintain the signed Attestation form. In addition, retain copies of above in the files of testing personnel. Once results are obtained, they should be reported to POCT, who will report them to CAP via mail, fax or electronic entry on the CAP website. Site Director and CLIA certificate Director or designees shall review survey results to assess performance and ensure compliance with the standard and comment. Scores of 100 % minimally requires documentation of review by the Director or designee. Scores between 100% and 80% requires a comprehensive investigation and remedial action documented of unsuccessful challenges. 2

3 Scores less than 80% requires a comprehensive investigation and documentation of remedial action of unsuccessful challenges. Scores of less than 80 percent may jeopardize a sites ability to continue to perform testing. Should a site fail proficiency, they will be required to immediately perform a comprehensive investigation and document remedial action. Operator re-training may be required. In order to avoid cessation of testing a site failing a challenge will be expected to develop and implement a more aggressive plan for performance improvement. Each site is responsible for completing survey challenges when they arrive. Anticipated Survey Periods: AQ2 (ABG) Product Receipt March June October Evaluation Receipt April July November Regulatory Requirements I. Each testing site must have a documented quality control program, which is developed in collaboration with or has been approved by the MGH Pathology Service. II. All test results must be maintained in patient records with all required information for four years Required information: 1. Patient s name 2. Medical Record Number 3. Patient s gender 4. Patient s age or date of birth 5. Date & time test collected, performed and reported 6. Ordering Physician 7. Responsible physician (if not 6) 8. Reference or Target Range 9. Test Performed 10. Test units 11. Lab name III. Additional information that must be retained for four years: IV. Other: 1. Testing personnel records 2. Quality control results 3. Product information (i.e. serial number, lot numbers, expiration dates, etc.), information on quality control and any remedial action 4. QC charts, maintenance sheets, reference and critical ranges 1. Universal precautions must be observed when handling any patient specimen. 2. A physician s order or standing order is required is required prior to performing test. 3. The Hospital Hand Hygiene policy must be adhered to at all times. V. Linearity/ Calibration Verification The testing site will perform and document linearity/calibration verification checks every six months. Competency Assessment 3

4 All operators must read the procedure manual, complete the GEM 3500 Quiz and run external (CVP) controls after initial training. For Blood Gas and Lactate analyses the competency assessment process is done at 6 months during the first year, then annually thereafter. Competency is assessed using six methods, examples of which are below: 1. Successful performance of routine patient testing, verified by direct observation 2. Supervisor monitoring of the recording and reporting of test results 3. Supervisor review of intermediate test results, QC, proficiency tests, and preventative maintenance performance 4. Successful performance of instrument maintenance function checks and calibration, verified by direct observation 5. Testing previously analyzed samples, proficiency testing samples, or internal blind testing samples. 6. Assessment of problem-solving skills Expired Operators: Operators that fail to meet competency requirements within 365 days will be locked out of the system. They will be required to undergo retraining and competency assessment according to above. Limitations and Interferences Room Air Metabolic Changes Elevated White Blood Cells or Reticulocyte Counts Improper Mixing Hemolysis Under-Heparinized Sample Changes to Manufacturer s Instructions or Method Verification Protocols Improper Installation Especially samples having a very low or high po 2 content. Similarly, pco 2 may be affected and subsequently ph and Ca ++ results as well. Errors can occur due to metabolic changes if there is a delay in the measurement of the samples. Samples will deteriorate more rapidly, even when kept in ice water. Errors will be introduced for measurement of hematocrit if the sample is not properly mixed prior to measurement. Potassium results will be falsely elevated if the sample is hemolyzed. Blood clot can form in the sensor chamber causing various sensor failures if sample is not properly heparinized. Results obtained may be compromised. The instrument must be installed per the manufacturer s instructions. Failure to do so invalidates any warrant, expicit or implied. The following substances can potentially interfere with sample analysis: Severely abnormal plasma osmolarities or abnormal levels of proteins or lipids. Thiopental sodium (see Note 2 in this section): May interfere with the sodium, potassium, pco 2 and ionized calcium readings (see Note 3 in this section). The anesthetic halothane may produce unreliable po 2 results due to interferences with po 2 sensor. The following tested drugs may interfere with glucose or lactate determination, causing falsely low readings: Drug Interference Observed High Normal Level* Flaxedil 2 mg/dl 1.4 mg/dl Ethanol 350 mg/dl 100 mg/dl (toxic) The following tested drugs may interfere with glucose and lactate determinations, causing falsely elevated readings: Drug Interference Observed Maximum Therapeutic Level* Acetaminophen (Tylenol) 15 mg/dl 2 mg/dl Isoniazide (Nydrazid) 2 mg/dl 0.7 mg/dl (toxic) 4

5 Thiocyanate 10 mg/dl 2.9 mg/dl Hydroxyurea 0.5 mg/dl 2 mg/dl The following tested anticoagulants may interfere with glucose and lactate determinations, causing falsely low readings: Anticoagulant Positive Interference Sodium fluoride 1 g/dl Potassium oxalate 1 g/dl Test Kit/Supplies/Equipment Description Part Number GEM Premier 3500 Analyzer and Accessory Pack Printer Paper, 5 rolls per Box GEM Premier 3500 PAK Cartridge (150 tests) (300 tests) Cartridge Storage: Room temperature: 15 to 25 C (59 to 77 F). Cartridge Preparation: None. Cartridge Expiration: Shelf-Life Expiration: The cartridge may be inserted up to and including the use-by (expiration) date shown on the packaging. The system will not accept an expired cartridge. On-board Expiration: The GEM Premier 3500 PAK cartridge must be replaced when the maximum number of tests are run, or when cartridge use-life is reached, whichever comes first. A cartridge must also be replaced if the power has been off for more than one hour or off more than 20 minutes if blood has rested on the sensors or an A or low O 2 calibration is in progress. The instrument displays Remove and discard the cartridge, as well as a reason for the removal request. Quality Control and Calibration Intelligent Quality Management (iqm ) is used as the quality control and assessment system for the GEM Premier 3500 analyzer. iqm is an active, quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. As part of this program, GEM CVP (Calibration Valuation Product) are external solutions intended to complete the calibration process and final accuracy assessment of the iqm cartridge calibration after initial warm-up. The reported values for the two levels of GEM CVP (two levels for ph, blood gases, and lactates) must meet manufacturer s specifications before the iqm cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iqm Process Control solutions, internal checks and software pattern recognition monitors the status of the system during the cartridge use life. GEM CVP External Calibration Valuation Product is used to complete the calibration process of the GEM Premier 3500 analyzer prior to use with patient samples and is comprised of the following three ampoule configurations: GEM CVP 1: Low ph, po2, lactate and high pco2 GEM CVP 2: High ph, po2, lactate and low pco2 Contril 9: Level 2, 96% Ordering Information Part Number Description Package Configuration GEM CVP 1 PAK 20 ampoules x 2.5 ml GEM CVP 2 PAK 20 ampoules x 2.5 ml Contril 9 L2 30 ampoules x 2.0 ml 5

6 Each time you insert a new cartridge, the GEM Premier 3500 analyzer will prompt you to run CVP testing. Testing will require approximately 3 minutes per ampoule to complete, and during this time, the analyzer will be unavailable for patient sampling. Cartridge Insertion and Warm-up 1. Unlatch the cartridge door on the instrument s right side by sliding the lock handle to the front and opening the door. 2. Check the label on the foil bag containing the GEM Premier 3500 PAK cartridge to be sure that the cartridge is not past its expiration date. CAUTION: Do not use an expired cartridge. The GEM Premier 3500 will not accept an expired cartridge unless that date is set incorrectly. Please refer to the Operator s Manual, page 2.7 for instructions on setting the date/time. 3. Open the foil bag, and remove the cartridge. 4. Check the inside of the foil bag to be sure that it is dry. CAUTION: If there is any moisture inside the foil bag, DO NOT USE the cartridge. Open a fresh GEM Premier 3500 PAK cartridge and call Technical Support at Instrumentation Laboratory. 5. Grasp the tab end of the plastic protective cover. Pull firmly to remove the cover. NOTE: The cartridge must be inserted into the instrument within one minute of removing the protective cover. Align the cartridge according to the labels. Using a rapid, smooth, continuous motion, insert the cartridge into the instrument s cartridge compartment. NOTE: The cartridge will not insert all the way into the compartment. A small lip of the cartridge will rest on the door. 6. When the instrument has successfully read and validated the barcode and the date/time has been accepted, it will prompt you to close the cartridge door. If the instrument displays a message that the barcode reader did not read the label, follow the directions on the screen to complete the insertion process. The instrument will make three attempts to read the barcode before prompting the operator to use the barcode gun. If the barcode cannot be read, contact IL Technical Support. 7. The instrument will prompt: Is the date/time correct? If correct, select YES to proceed with warm-up. Otherwise, select NO to correct the date/time. The instrument will prompt: Remove cartridge. Remove the cartridge (see 5.9 Cartridge Removal ) to begin the process again, changing the date and time when prompted. 8. Close the door, and slide the lock handle toward the back of the unit. 9. The cartridge door will lock. The GEM Premier 3500 will display the Cartridge Warm-up screen. 10. Cartridge Warm-up 11. Cartridge warm-up requires approximately 30 minutes. Samples cannot be analyzed during cartridge warm-up, but the instrument does allow access to many of the menu commands. 12. During cartridge warm-up, the instrument brings the measuring chamber to the proper temperature and performs several rinses and calibrations. If an error occurs during warm-up, the instrument will prompt for removal of the cartridge (see 5.9 Cartridge Removal for instructions). 13. The GEM Premier 3500 will also determine the type of cartridge during cartridge warm-up. If a non-iqm cartridge is inserted, the instrument will continue with warm-up. If an iqm cartridge is inserted, the instrument s response will depend upon how iqm Mode has been configured: 14. If iqm Mode is ON, it will be left ON. 15. After iqm Mode has been configured (ON or OFF), the mode cannot be changed for the duration of the inserted iqm cartridge. After the cartridge is removed, iqm Mode will remain at its current setting but will be available for changing, if desired. 16. When cartridge warm-up is complete, the instrument will display the Ready screen. 17. If an iqm cartridge is inserted and iqm Mode is ON, the instrument will display a reminder to run all levels of CVP material, and the status of all analytes will be set to Pending CVP. All levels of CVP material (i.e. CVP 1 and CVP 2) and Contril 9 L2 must be run and within range before patient samples can be reported. A. Touch CVP on the Ready screen. B. Enter an operator ID by entering the appropriate characters on the keypad or with the barcode gun. Touch ENTER. C. Select the CVP material to be used: D. Open the door to the ampoule spinner, and insert and release the ampoule. The reader will spin the ampoule and read the barcode. E. If the lot number is not found, the instrument will prompt for a different ampoule or for selection of material from a list of defined material. F. If the lot number matches the lot number of a defined material, the instrument will prompt for sample aspiration. If the selected material only contains analytes that have failed calibration, the instrument will abort the sampling process. G. Prepare the CVP material: 6

7 H. Mix the solution by vigorously shaking the ampoule. I. Tap the solution from the tip of the ampoule to restore solution to the bottom part of the ampoule. Allow bubbles to dissipate for at least 10 seconds. J. Use the instrument s ampoule breaker to snap off the ampoule neck. K. CAUTION: Analyze CVP solution within one minute of opening the ampoule. L. Position the ampoule on the sampler when the screen instructs you to do so. Make sure the sampler is near, but not touching, the bottom of the ampoule. Touch OK. M. Remove ampoule AFTER the instrument beeps four times and displays the message Remove the sample. The instrument will wait two seconds for removal of the sample before withdrawing the sampler. N. Dispose of ampoule in an appropriate waste container. The instrument will take 85 seconds to process the sample and display results. During this time, a progress indicator will be displayed. The Sample Information screen will also be displayed to prompt for entry of sample information. CVP Sample Information 1. Enter Operator ID as necessary: 2. Operator Security is ON and an operator password was previously entered, the operator ID associated with the password will be displayed. This ID cannot be changed. 3. Enter an optional sample comment to record a short description with the sample. This comment, up to two lines of 24 characters each, will be saved, printed, and transmitted with the sample. CVP Sample Results Measured results will be displayed along with the expected results. If the measured values fall within the expected range, Pass will be displayed. If a measured value falls outside the expected range, the screen and print-out indicate a failure with the message Fail and an F on the hard copy print-out next to the analyte which has failed. Refer to CVP Failure, below CVP data is automatically downloaded into an on-board computer memory for future analysis and transferred to disk for record keeping. NOTE: The instrument stores all data generated while a cartridge is in service and the most recent 20 cartridges. CVP Sample Disposition If one or more of the CVP analytes failed and you select the ACCEPT or DISCARD button, the instrument will prompt with the message: CVP failure. Perform 2-point calibration before repeating the failed CVP sample. Touch OK, then initiate a 2-point calibration from the DIAGNOSTICS menu prior to repeating the CVP sample. NOTE: The sensor status on the Ready screen will not change to Green/OK until all CVP materials associated with that analyte are run and passed. Sensor status will remain as either yellow/pending CVP, or red/failed CVP. CVP failures will be cleared when the failed CVP material is run and passed or when the cartridge is replaced. Touch the ACCEPT button after the sample has been reviewed and deemed satisfactory and after any user-entered information has been edited. No further editing of the sample will be allowed. When you accept a CVP sample, the instrument will: Set the sample s disposition to ACCEPTED, and save the sample to the database. Print a sample report. Send the results to the IMPACT. Satisfy the CVP requirement. Return to the Ready screen. Touch the DISCARD button after the sample has been reviewed and deemed not valid for some reason. No further editing of the sample will be allowed, and the sample s disposition cannot be changed from DISCARDED. The instrument will prompt to confirm the disposition. If NO is selected, the discard request will be aborted. If YES is selected, the instrument will: Set the sample s disposition to DISCARDED, and save the sample to the database. Return to the Ready screen. CVP Failure If a measured value falls outside the expected CVP range for an analyte, the screen displays CVP FAIL and highlights any analyte that failed. To correct the failure: 1. Use 2-PT CAL on the DIAGNOSTICS menu to run a 2-pt calibration before trying to repeat the failed CVP run. 2. Repeat the CVP with freshly opened CVP material from the same CVP lot. 3. If the failure is corrected, ACCEPT the CVP results. 7

8 4. If the original failure is corrected but a new analyte fails, repeat the CVP with freshly opened CVP material from the same CVP lot one more time. 5. If the failure is corrected, ACCEPT the CVP results. 6. If the failure is not corrected, remove the cartridge and notify Technical Support (see 4.5 Cartridge Removal ). NOTE: If a CVP failure persists, the analyte(s) will not be available. IMPORTANT: Ensure that enough CVP material is on hand toward the end of a lot to clear any existing failure conditions. Only CVP material from the same lot can clear an error condition for that lot. If a patient sample is run while an analyte is in the Pending CVP or Failed CVP state, the result will not be reported. On the screen, the result will be flagged with V and blanked out. The printed report will display PENDING CVP or FAILED CVP as appropriate. Calibration Verification / PVP Calibration verification must be performed: 1. Every six months. 2. If there is any major maintenance or replacement of any critical parts that may influence test performance. 3. Instrument replacement 4. Control results indicate that there may be a problem with the test system. IL Performance Verification Product is used for testing system performance of ph, pco2, po2, Na+, K+, Ca++, Glucose and Lactate across the analytical reportable range on IL Critical Care Analyzers. Part Number Description Package Configuration IL PVP 4 ampoules x 5 levels x 2.5mL IL PVP unopened ampoules are stable when stored at C for up to 3 months, or at 2-8 C until the expiration date shown on the label. DO NOT FREEZE. PVP Directions for Use 1. Equilibrate 22 degrees C for at least 8 hours prior to use. 2. Immediately prior to use, hold the ampoule by the top and shake vigorously for 10 seconds 3. Restore liquid to the bottom of the ampoule with gentle tapping 4. Carefully snap open the ampoule utilizing the appropriate ampoule breaker provided with the Gem Premier 3500 system. 5. Analyze the sample immediately. 6. Analyze the IL PVP solutions in the following series: a. Level 1; all 4 ampoules b. Level 2; all 4 ampoules c. Level 3; all 4 ampoules d. Level 4; all 4 ampoules e. Level 5; all 4 ampoules 7. Record data on the data sheet provided with the PVP Kit 8. Contact IL Technical for assistance in evaluating results Specimen Collection Sample Volumes The syringe that is used must be filled nearly to capacity to prevent excessive heparin concentration in the sample. Minimum sample requirements for the cartridge in use are as follows: Sample Volume: Menu: Sample Types 150 µl ph, pco2, po2 and Lactate 145 µl ph, pco2, po2 and Lactate in the Capillary mode (Not currently used) The sample type that is collected depends upon the type of study to be performed: 1. Level 1 Study: Venous Blood, Post Exercise 8

9 2. Level 2 Study: A-line (Arterial) in place; Pre/During/Post-exercise 3. Level 3 Study: A-Line and PA (Pulmonary-Arterial Line); Arterial and Mixed-Venous Pre/During/Post-exercise 4. Single Stick: Arterial Blood Gas Only (No exercise) Radial or Ulnar Arterial Cannulation for Multiple ABGs 1. Prepare flush solution. Add 0.3 ml Heparin (1000 units/ml) into 30 ml 0.9 NaCL 2. Assemble the arterial cannulation tray to include the following items: Alcohol Prep Pads 3X3 Sponges 1 ml syringe filled with 2 % Xylocaine 3 ml syringe attached to a microbore extension set with flush solution filled with 2.5 ml heparinized saline from step #1 above Roll of micropore tape Sterile wire 2 Iodine wipes 2 Angiocaths 20 GA 1.25 inch 3. ID the patient ( name & date of birth) and explain the process 4. Drape a chux pad on the patient table to provide a clean surface and a method to contain any blood contamination 5. Palpate the patient radial and ulnar arteries 6. Perform the Allen s test: Depress both radial and ulnar arteries with your thumb Instruct patient to open and close fist 3 times. Hand should lose pink color due to lack of blood flow Release Radial artery. Hand should regain pink color due to return of blood flow Depress both radial and ulnar arteries with your thumb Instruct patient to open and close fist 3 times. Hand should lose pink color due to lack of blood flow Release Ulnar artery. Hand should regain pink color due to return of blood flow 7. If the Allen s test shows good collateral circulation, continue to #9. If the Allen s test shows poor collateral circulation (pink color is not returned with both arteries) try the other hand and repeat #5. 8. If both hands fail the Allen s test, the test should not be cancelled and the brachial artery should be prepared-see Brachial artery cannulation-start at step#9 9. Technologists should observe hand hygiene policy and wear gloves 10. The artery should be palpated again and wrist cleaned with an iodine & alcohol swabs 11. A local anaesthetic should be used for this procedure. A small wheal is raised with a local anesthetic through 27 GA needle. It has been documented that the majority of punctures are accomplished on the first attempt; however, a wheal allows another attempt to be made without pain. 12. Wrist must be stabilized to accomplish this procedure. Use wrist over table technique or roll under wrist technique. 13. When ready to puncture the artery, the patient should be told when to expect the puncture 14. The physician or technologist should assemble the following: Angiocath, Flush solution, 2 strips of 0.5X3 micropore tape 15. Skin should be cleaned again with a alcohol prep,pad 16. The physician or technologist should puncture the skin at degree angle 17. When artery is pierced, blood should begin flowing into the angiocath. The needle should then be advanced a few mm then cath should be advanced over needle into the artery. Non Dependent hand should occlude flow and needle removed. If catheter does not advance over the needle, open sterile wire package. Advance needle until flow occurs, remove needles flow must be maintained to proceed. Advance wire through cath-then advance cath over wire into artery. 18. Syringe attached to a microbore extension set with flush solution should be attached and 0.5mL of flush should be injected slowly to prevent burning sensation 19. Excess blood should be cleaned around site 20. Tape angiocath in place; a. Tape under cath-sticky side up. Criss-cross with forward attachment b. Tape over top of angio cath c. Cut 1 X3 tape-attach over angiocath attached to a microbore extension set 21. Syringe should not be removed 22. Place needle in a sharps container according to Needle Disposal Policy 23. Upon completion of study, remove the tape. 24. Withdraw the catheter and compress the artery at the site for 5 minutes. Under no circumstances is the patient allowed to compress 25. Release the compression and observe the site for leakage 9

10 26. Pressure sterile dressing should be applied and patient instructed to remove after 2 hours. Bleeding after removal should warrant another dressing. If bleeding persists, notify closest Emergency Dept. If there is difficulty in placing a line, after two attempts, the fellow should get a second year fellow or staff person to place the line. If a line can not be placed, then oximetry should be performed so that saturation with exercise can be reported. Arterial Puncture for Arterial Blood Gas Sampling 1. Assemble the blood gas puncture tray to include the following items: Alcohol Prep Pads 3X3 Sponges Arterial Blood Gas Sampling kits (Pulsator Plus) which includes: Arterial blood gas sampling kits (23.5 I.U. Units Heparin/mL) Needles 23GA 1 inch Caps Alcohol preps Sponges Bandaids Iodophor Prep Pad 2. Arterial blood gas sample syringe (Portex #4042 with dry lithium heparin) 3. Butterfly needles (23 GA 0.75 inch with 12 inch tubing) 4. ID the patient ( name & date of birth) and explain the process 5. Follow steps #3- #7 above 6. If both hands fail the Allen s Test, the test should be cancelled and the referring physician notified. 7. Technologists should observe hand hygiene policy and wear gloves 8. The artery should be palpated again and the wrist cleaned with an alcohol swab 9. A local anesthetic may be used, if necessary 10. A small wheal is raised with a local anesthetic through a 27 GA needle. (It has been documented that the majority of punctures are accomplished on the first attempt, however, a wheal allows another attempt to be made without pain) 11. Any gauge needle from may be used to obtain a sample from the radial or ulnar arteries 12. When ready to perform the puncture, inform the patient 13. Technologist should assemble the needle to syringe or ready the syringe for attachment to a butterfly needle when blood begins to flow into tubing 14. Two different methods are used to collect arterial blood: 15. For syringe with needle technique, go to # For Butterfly needle without syringe technique, go to # Technologist should puncture the skin at degree angle 18. When artery is pierced, blood will flow into the syringe. Blood pressure will drive flow and fill the syringe. Do not withdraw blood using the plunger of the syringe as that method may introduce venous blood. 19. Go to # Technologist should puncture the skin at angle 21. When artery is pierced, blood should begin flowing into the butterfly tubing. When flow is achieved, attach the syringe to the butterfly tubing. Blood pressure will drive then flow and fill the syringe. Do not withdraw blood using the plunger of the syringe as that method may introduce venous blood. 22. Go to # The needle should be withdrawn after 2 ml of blood is obtained in the syringe and the artery is compressed at the site for 5 minutes (Technologist may allow the patient to compress, if understaffed, to allow for analysis of the sample) 24. Needle should be disposed of according to Needle Disposal Policy 25. Air should be tapped out of sample using a sponge to prevent contamination and the sample should be capped. 26. Analyze the sample ASAP, in less than 20 minutes 27. Upon release of compression, the puncture site is observed for evidence of leak 28. Bandaid or other sterile dressing should be applied. Sample Mixing For syringe samples: 1. Expel all air. 2. Mix the sample thoroughly. 3. Invert at least 3 times, and roll between outstretched palms at least 5 times if drawn within 5 minutes of sampling. Manually or mechanically rotate through 2 axes for at least 2 minutes if sample is drawn more than 5 minutes from time of analysis. 4. Push out a few drops of the sample onto a gauze pad to ensure there is no clot in the syringe tip. 10

11 Venipuncture for Collection of Venous Blood 1. Assemble the venipuncture tray to include the following: Alcohol Prep Pads 3 X 3 Sponges Vacutainer Barrels with needle protection caps Vacutainer needles 20 GA 1.5 inch Tourniquet Band-Aids Vacutainer tubes (green top - heparized) 2. ID the patient (name & date of birth) and explain the process 3. Drape a chux pad on the patient table to provide a clean surface and a method to contain any blood contamination 4. Technologists should observe hand hygiene policy and wear gloves 5. Apply the tourniquet to the preferred arm above the elbow 6. Needle should be attached to the vacutainer and all tubes readied. 7. Vein should be palpated and skin should be cleaned with an alcohol prep pad 8. Inform the patient when ready to perform the venipuncture. 9. Technologist should puncture the skin at degree angle pulling up on the needle to prevent a deep stick below the vein 10. When technologist determines that needle is in vein or at least below skin level: 11. Vacutainer tube is advanced, while maintaining stability or needle/barrel assembly. This prevents puncturing the vein 12. If needle is in the vein, blood will fill the vacutainer tube 13. If needle is not in vein, blood will not fill the vacutainer tube. Needle/barrel assembly should be redirected to the vein. 14. When first tube is filled, it should be retracted, mixed if necessary, and another vacutainer tube is advanced, while maintaining stability of needle/barrel assembly 15. When all tubes are filled, remove the tourniquet 16. Withdraw the needle/barrel assembly and compress the vein at the site for a few minutes using a 3 X 3 sponge (Technologist may allow the patient to compress, if understaffed, to allow for analysis of the sample) 17. Dispose of needle according to Needle Disposal Policy 18. Upon release of compression, the puncture site is observed for evidence of leak 19. Apply bandaid or other sterile dressing. Patient Test Procedure The GEM Premier 3500 analyzer is designed for intuitive use, and provides clear direction when you are operating the system. Changes in color signal different conditions: (i.e. Green Fully operational or normal; Yellow Conditional state, awaiting specific action; Red Stopped or non-functional) Ready Screen: The GEM 3500 is ready to analyze samples whenever it displays the Ready Screen. 1. Technologists should observe hand hygiene policy and wear gloves 2. Choose the analytes to be measured from the left side of the Ready Screen (i.e. the Analyte Status Area). If all, then proceed to next step. 3. Specify the sample type by touching Arterial, Venous, Capillary, or other. 4. Enter an authorized operator password by entering the appropriate characters on the keypad or with the barcode wand. Touch ENTER. 5. Enter the patient ID by entering the appropriate characters on the keypad or with the barcode wand. Touch ENTER. 6. Mix the sample thoroughly: a. Expel all air from the syringe. b. Grasp the syringe firmly by its barrel with a finger tightly over its cap, and repeatedly invert (rock) it at least 5 times. c. Roll the syringe between flat palms at least five times. 7. Check for the presence of clots: remove the cap, and expel a drop or two of the sample onto a gauze pad. If clots are suspected, obtain another sample. 8. Analyze the sample immediately: position the sample so that the sampler is near, but not touching, the bottom of the syringe plunger. Then touch OK. 11

12 9. Remove the syringe, capillary tube, or capillary and adapter from the sampler when the instrument beeps four times and prompts you to do so. CAUTION: Care should be taken to remove the sample quickly so as not to bend the sampler. 10. Dispose of sample in a biohazard waste container. 11. The instrument will take 85 seconds to process the sample and display results. During this time, a progress indicator will be displayed. The Patient Information screen will also be displayed to prompt for entry of sample information. 12. If the sample analysis includes CO-Ox analytes, the instrument will prompt for introduction of the CO-Ox sample. Touch OK, and introduce the sample to the CO-Oximeter. Result Reporting The Patient Sample Results screen is displayed after: patient results are ready, and you have touched EXIT at the Patient Information screen (if that screen was presented), and interference/micro clot determination, if enabled, has been completed. The Patient Sample Results screen will be displayed for 90 seconds. After 90 seconds, If Patient Sample Auto-Accept is ON, the sample will be given a disposition of ACCEPTED. If Patient Sample Auto-Accept is OFF, the sample will keep whatever disposition you have assigned it. If no disposition has been set, it will be given a disposition of PENDING It is the policy in Pulmonary CCU that each result is manually accepted by the technologist. The Patient Sample Auto-Accept should be OFF: Touch ACCEPT to assign the sample an ACCEPTED disposition. The instrument will: Refresh the screen to show the ACCEPTED disposition Print the Patient Sample Report Send the results to IMPACT (see IMPACT Reporting Policy) Touch DISCARD to assign the sample a DISCARDED disposition. The instrument will: Prompt to confirm the disposition Refresh the screen to show the DISCARDED disposition. Discarded samples must be manually printed and transmitted. They will be included with all other samples when the sample database is copied. Touch EXIT without first selecting one of the other dispositions to assign the sample a PENDING disposition. The instrument will: Save the sample to the sample database withn a Pending Disposotion Return to the READY screen Touch EXIT after selecting one of the other dispositions to assign the disposition, save the sample to the database, and return to the Ready screen. Reference Values 12

13 Test Reference Range Courtesy Critical Value Range* Analytical Range PCO2 (arterial or venous) mmhg mmhg >50 mmhg ph (arterial or venous) < PO2 (arterial or venous) mmhg mmhg <55 mmhg Lactate mmol/l >4 mmol/l *Note: Values that are trending towards the critical MGH values are called to the ordering provider (referring physician) as a courtesy. 1. Validate low po2 values with oximetry: If the po2 is <60, then oximetry should be checked to help validate that the po2 was accurate. For po2 of 55, expected O2 Sat is 88%: for po2 of 50, expected o2 is 80%. If the O2 Sat is much better that was expected from po2 (e.g.: po2 of 46 and O2 Sat 90%) then venous sample was most likely drawn. An arterial blood gas should be redrawn. 2. If a critical value is detected, the sample must be analyzed again to verify the results. Time is recorded after the sample has been analyzed and documented as time (a) 3. Ordering provider is immediately notified of the critical value: If the ordering provider is not reached within 5 minutes, another all/page is sent. If the ordering provider is not reached within 10 minutes, the responsible physician will be the Pulmonary Function Fellow If unavailable, both Pulmonary Consult Fellows will assume this responsibility If unavailable, PFT Lab Attending Physician will assume this responsibility. 4. Notification should include: Written evidence of notification should be recorded in the critical value result log in the monthly section of the ABG COOX Troubleshooting Review Log for the current year and Critical Value Reporting/Notification Report For Inpatients: Send a Preliminary report to the floor with a brief note in the progress note section with blood gas or oximetry results For Outpatients: Send a Preliminary Report to the patient s physician if the patient is returning on the same day A phone call or to the physician s office should be made The patient must remain in the lab until cleared by the physician or until patient signs a refusal statement on the Critical Value Reporting/Notification Report 5. Compliance Documentation: All notification times (b-a) from the Critical Value Reporting/Notification Report must be less than 40 minutes.(b= time that referring physician or designee receives the report; a= time sample run) All patient blood results shall be printed at the end of each month to assure that critical values were not missed and documented in the monthly section of the Gem 3500 Corrective Action Log with patient name, DOS, and Compliance. Instances of noncompliance will be reviewed at the weekly PFT Lab meeting so that corrective action can be planned. NO should also be reported. All Critical Value Reporting/Notification Reports will be reviewed monthly and compliance must be greater that 95%. Instrument Maintenance Cartridge Removal The cartridge must be replaced when its use-life or sample capacity has been reached. A cartridge must also be replaced if the power has been off for more than one hour or off more than 20 minutes if blood has rested on the sensors or an A or low O 2 calibration is in progress. The instrument displays Remove and discard the cartridge, as well as a reason for the removal request. 13

14 The instrument saves the data from 20 to 40 cartridges. After 40 cartridges have been inserted, the instrument will prompt you to perform database maintenance. See Copy Cartridge Data in the GEM 3500 SOP for information about saving cartridge data. Copy Cartridge Data 1. Slide the handle on the right side of the instrument toward the front of the instrument and open the door. 2. Grasp the cartridge in the compartment, and pull it straight out. 3. Dispose of cartridge in an appropriate biohazard container. 4. Install a new cartridge when the instrument displays the Insert Cartridge screen. You can copy the data that the instrument has generated while a cartridge is in use whenever the instrument is at the Ready screen, or between instrument acknowledgment of cartridge removal and insertion of a new cartridge. One data diskette must be used per cartridge, even if the cartridge has processed only part of its full capacity. NOTE: If the disk already contains cartridge data, the instrument will give you the opportunity to replace the disk or overwrite the data. 1. Touch COPY CART DATA on the DIAGNOSTICS menu. 2. Select the cartridge to be copied by touching its entry in the listing. 3. Touch COPY. 4. Insert a blank, PC-formatted, high-density 3.5 diskette, with its label facing the front of the instrument. 5. Touch OK. When copying is complete, the instrument will display a message stating so. 6. Remove the disk, and touch EXIT. 7. Write-protect the disk by sliding the square tab on the back of the disk toward the edge to expose the small hole. 8. Label and store the disk in a safe place. Copy iqm Data You can copy the iqm performance data stored by the instrument to a diskette with COPY iqm DATA on the DIAGNOSTICS menu. Copying iqm data does not remove it from the instrument. iqm data will be removed from the instrument only when the data is older than 1 year. At that point, the data from the oldest month will be automatically deleted. 1. Select COPY iqm DATA from the DIAGNOSTICS menu. 2. Insert a blank, PC-formatted, high-density, 3.5", with its label facing the front of the instrument. 3. Touch OK. When copying is complete, the instrument will display a message stating so. 4. Remove the disk, and touch EXIT. 5. Write-protect the disk by sliding the square tab on the back of the disk toward the edge to expose the small hole. 6. Label and store the disk in a safe place. Instrument Cleaning Wipe the outer surface of the case using a soft cloth moistened with a hospital approved disinfectant and cleaning solution.a 10% mixture of liquid chlorine bleach (Mercury free) and water may also be used. Wipe the surface of the touch screen using a soft cloth moistened with water or a mild, non-bleach cleaning solution. CAUTION: Do not use an abrasive cleanser, bleach, or organic solvent as this will scratch the screen. Do not pour solution directly onto the screen. Inspect the area into which the cartridge inserts, and clean as necessary. Instrument Maintenance 1. Empty Ampoule-Breaker Storage Container: Periodically remove the QC ampoule breaker storage container and empty contents into an appropriate container. QC solution stains may be removed using a mild cleaning solution. 2. Replace Printer Paper: The MESSAGES button on most main screens will turn yellow when the internal printer runs out of paper.caution: Use only paper supplied by Instrumentation Laboratory. Other papers can damage the printer. 14

15 a. Open the door to the printer paper compartment as shown. b. Move the lever UP. c. Remove the spent paper roll. d. Place the new paper roll into the cup in the base of the door. e. Push the paper into the printer and thread it over the top roller. f. Move the lever DOWN. g. Thread the paper over the door, and close the door. NOTE: The GEM Premier 3500 uses thermal paper that can only be printed on one side. Technical Support Call Tech Support for questions or troubleshooting assistance at References 1. Instrumentation Laboratory GEM Premier 3500 Operators Manual, P/N Gornall, A.G.: Applied biochemistry of clinical disorders. Chapter 6, Respiratory Disorders, p. 94, Burke, M.D.: Blood gas measurements. Post grad. Med. 64:163, Gradwohl's Blood gas analysis and acid-base balance: Principles & Techniques. Chap. 17, p. 351, Fleisher & Schwartz. 5. Pesce, A. and Kaplan: Methods in Clinical Chemistry, C.V. Mosby Co., St. Louis, MO, Shapiro, B. Harrison & Walton: Clinical Application of Blood Gases, Year Book Medical Publishing, Inc., Chicago, IL, Ng, R. H, et al: Factitious cause of unexpected arterial blood-gas results. N Engl J Med 310: , Westgard, J. O., Groth, T: Power Functions for Statistical Control Rules, Clinical Chemistry, 25:394, Burnett,R.W., et.al: Recommedations on Whole Blood Sampling, Transport, and Storage for Simultaneous Determination of ph, Blood Gases, and Electrolytes. Journal of the Internations Federation of Clinical Chemistry, Sept Interference Testing in Clinical Chemistry - Proposed Guideline, NCCLS Document EP7-P, Vol 6, No