Written By: Joann O Connor Date: 03/05/2017 Effective Date: 03/28/2017 1

Transcription

1 Department Of Pathology Point of Care Testing POC i-stat 1-NW Version#7 Printed copies are for reference only. Please refer to the electronic copy for the latest version. A. Purpose: The i-stat 1 analyzer is used in conjunction with i-stat cartridges for the simultaneous quantitative determination of specific analytes in whole blood. Just 2-3 drops of fresh whole blood is all that is required, and a portable, batterypowered analyzer displays quantitative test results in approximately 2 minutes for 6+ and 10 minutes for troponin. Infrared communication devices allow all patient information obtained at bedside to be transmitted to a centralized information system for record keeping and billing. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes. 1.Principle: A single-use disposable cartridge contains a microfabricated biosensor array, a calibrant solution, fluidics system and waste chamber. Sensors for analysis of sodium, potassium, chloride, BUN and glucose are available in the 6+ cartridge and for troponin I(cTnI) cartridge we use at NW. A whole blood sample of approximately 2 to 4 drops of blood is dispensed into the cartridge well. A hand held analyzer into which the blood filled cartridge is placed for analysis automatically controls all functions of the testing cycle including fluid movement within the cartridge calibration, and continuous quality monitoring. The analyzers have thermal control testing at 37 C. Information is then transmitted from the analyzer to the RALS data management systems where the data can be stored, organized and transferred to the laboratory information system. B. Policies: 1. Tests will be performed by certified operators using correct policies and procedures for Northwest Hospital including NW POC Safety and Infection Control Plan. 2. Only patient s with proper identification number(account number) may be tested. 3. Tracking of trends in patient results is the responsibility of clinical personnel. 4. Personnel should compare with caution laboratory and bedside test values. The results may not be directly comparable because of the different methods used. Can not directly compare lab to istat troponin levels. Effective Date: 03/28/2017 1

2 C. Supplies and Storage: 1. Cartridges: a. Stored at 2 to 8 C. Do not allow cartridges to freeze. b. Cartridges may be stored at room temperature for 14 days(18 to 30 C or 64 to 86 F) c. Cartridges are never returned to refrigerator once they have been at room temperature. d. Mark the label on the box when taking out of the refrigerator with the date removed and the two week discard date. e. Cartridges should remain in pouches until time of use. f. Do not use after expiration date. g. Cartridges need to be kept in the box or bag that was brought to the unit until they are used. D. Specimen 1. Specimen type: For 6+cartridge: a. Fresh whole blood collected in a collection tube with lithium heparin anticoagulant(dark green top tube). Fill collection tubes to capacity. b. Fresh whole blood collected in a labeled plain plastic syringe(to be tested immediately) or a syringe with lithium heparin. For Troponin I cartridge: a. Heparinized whole blood or plasma samples collected in syringes or evacuated tubes containing lithium or sodium heparin b. Non-heparinized whole blood samples tested within one minute of drawing from a patient into a plastic syringe or plastic evacuated tube containing no additives. The cartridge contains sufficient reagent to heparinize the freshly drawn sample. Note: The use of whole blood or plasma samples containing other anticoagulants such as EDTA, oxalate, and citrate will cause deactivation of the alkaline phosphatase, resulting in decreased ctni readings. Capillary tubes and direct skin punctures (e.g. fingersticks) should not be used with the ctni cartridge. 2. Patient preparation: Make sure the patient is identified by name and date of birth prior to collecting sample. 3. Handling conditions: a. Fresh whole blood in a plastic syringe without anticoagulant: Test immediately after collection. b. Fresh whole blood collected in a collection tube or syringe lithium heparin anticoagulant: Fill to capacity and test within 10 minutes of collection. 4. Specimen labeling: A patient identification label needs to be attached properly to each syringe and collection tube used for i-stat testing. 5. Sample rejection criteria: a. Evidence of clotting Effective Date: 03/28/2017 2

3 b. Specimen collected in vacuum tubes with anticoagulant other than lithium heparin. c. Other sample types such as urine, CSF and pleural fluid. E. Specimen collection: 1. In-Dwelling line: Back flush line with sufficient amount of blood to remove intravenous solution, heparin, or medication that may contaminate the sample. Recommendation: five to six times the volume of the catheter, connectors, and needle. 2. Arterial specimens: Fill a plain syringe or fill a blood gas syringe, labeled for the assays to be performed, to the recommended capacity, or use the least amount of liquid heparin anticoagulant that will prevent clotting. Under-filling syringes containing liquid heparin will decrease results due to dilution. Mix blood and anticoagulant by rolling syringe between palms for at least 5 seconds each in two different directions, then invert the syringe repeatedly for at least 5 seconds. Discard the first two drops of blood. 3. Venous Specimens: If a cartridge cannot be filled immediately, collect sample into a evacuated blood collection tube or a syringe containing lithium heparin anticoagulant. Mix blood and anticoagulant by rolling syringe between palms for at least 5 seconds and then inverting the syringe repeating for at least 5 seconds. If possible, test samples immediately after being drawn: sample should be tested within 10 minutes.(remix before testing). 4. Universal precautions need to be followed during testing. Gloves need to be worn during collection and testing of patient samples. 5. NW hand hygiene procedures need to be followed. Hand hygiene is performed before and after the procedure. F. Equipment and Materials: 1. Equipment: i-stat analyzer 2. Materials/supplies: a. Alcohol swab b. 2X2 gauge c. Tube/syrine: venous/arterial d. i-stat cartridge(all i-stat cartridges must stand at room temperature for 5 minutes(individually) or 1 hour(entire box of 25 cartridges) before use. e. Gloves G. Procedure 1. Press the On/Off key to turn analyzer on. 2. Press 2 for i-stat cartridge. 3. Scan operator bar code or hand enter number. 4. Scan patients account number on patient s wrist band. If unable to scan wrist ban, may scan chart label or hand enter 12 digit account number. Repeat as prompted. 5. Scan the lot number on the cartridge pouch. Position the barcode 3-9 inches from scanner window. Press and hold the scan to activate the scanner. Align the Effective Date: 03/28/2017 3

4 red laser light so it covers the entire barcode. The Handheld will beep when it reads the barcode successfully. 6. Remove the cartridge from pouch, taking care to hold cartridge by its sides and not touching the contact pads. 7. Obtain sample in appropriate container. 8. Direct the dispensing tip or capillary tube containing the blood into the sample well. Once in contact with the sample well, the blood will be drawn into the cartridge. 9. Dispense the sample unit it reaches the FILL TO mark on the cartridge.(do not press on the sample well). 10. Insert the cartridge into the cartridge door until it clicks into place. 11. At this time, you can enter sample type. 12. Press page to go back to result screen. 13. Print results if needed and attach to result sheet. See attached. This is not a part of the permanent record. 14. If you get a critical result, record doctor notified, result and time and date. 15. Leave i-stat on and place on downloader, making sure results transmit. Results should appear in Power Chart. 16. Remove cartridge from instrument and discard cartridge in biohazard container. 17. Should the i-stat system become inoperable for any reason, there is a back up one in the lab. The operator may also elect to send a sample to the lab. H. Results 1. Suppressed Results: There are two conditions under which the i-stat will suppress the presentation of results. a. Results outside the system s reportable range are flagged with a < or > indicating that the result is outside the reportable range. Action: Send specimen to the laboratory for analysis or Clinical action may be appropriate. b. Results which are not reportable, based on internal QC rejection criteria are flagged with****. Action: Analyze the specimen using another cartridge. If the results are suppressed again, send specimen to the laboratory for analysis. 2. Critical Values: (See attachment for critical values) a. It is recommended that any test that exceeds the critical limit be repeated. The lab strongly encourages sending a sample to the lab, but if the doctor refuses to do so, the lab ask that the sample be repeated on the i-stat. If a high potassium is suspected because of an improper draw, please repeat with a different sample on the i-stat. If still high, send specimen to the lab. Effective Date: 03/28/2017 4

5 b. The physician in charge of the patient should be notified of the critical result. The doctor notified, date and time of the notification should all be in adhoc section of power charting. I. Quality control(also seepoc QC/QA for moderate complex testing- LBH ) Abbott s i-stat level 1 and level 3 controls for 6+ cartridge Abbott s i-stat level 1 and level 3 troponin controls 1. Electronic Simulator: a. QC is done automatically every eight hours by the internal Quality control set in the instrument. b. Results from the electronic simulator are transmitted and stored in the RALS data management system. c. Should the i-stat internal QC fail, or if the instrument is dropped, the external Electronic simulator can be used. d. Insert Electronic Simulator into the analyzer. e. If PASS is displayed on the analyzer, remove the Electronic Simulator and dock the meter. If Fail is displayed again, call the POCC and get a replacement or go to the lab for one. 2. Liquid Controls: a. Per shipment/lot number to hospital Two levels of control performed in duplicate on each cartridge lot per shipment. b. Weekly quality control will be performed using level 1 and level 3 on Monday. There is a period of after 12 midnight Monday morning til 3pm Monday afternoon to perform the quality control. After that point the instruments will go on lock out. Units will get the controls from Pathology each Monday and operators on the units will run the controls. If the controls fail, operators will repeat and record actions on sheet in POC book on units. Instruction for running the Weekly Quality control 1. Select 1 i-stat 6+ or Troponin 2. Select 3- Quality Tests 3. Select 2-Schedule 1 4. Select 1-i-STAT 6+ or Troponin 5. Select either 1 for Level 1 or 2 for level 3 6. Scan or hand enter operator identification 7. Scan barcode on control bottle 8. Scan cartridge barcode on packet 9. Dispense control til the Fill to line and close cartridge and insert in analyzer. 10. Should display PASS if control values were in range. If any control levels fail, patient testing may not be done until controls are repeated and pass. Effective Date: 03/28/2017 5

6 c. Documentation of cartridges, lot numbers and controls will be stored in Pathology. d. For work up of a new meter, see POC QC/QA for moderate complex testing-lbh. Storage: 1. Store controls at 2 to 8ºC(35º to 46ºF). 6+ Controls may be stored at room temperature (18º to 30ºC) for five days. Do not use after expiration date on the box and ampules. 2. Target ranges: The packet insert ranges for the i-stat QC will be used to determine acceptability of QC. These ranges will be downloaded to the RALS system each time there is a new control lot. 3. Troponin controls once opened are good for 30 days if kept tightly capped and stored in refrigerator between uses. J. Analyzers: 1. Cleaning Always wear gloves when cleaning the meter. Clean the meter with the following products using wet and dry times listed on those products. 10% bleach (bleach wipes or PDI Super Sani-Cloth 2. Disinfect Use PDI Sani-cloths to wipe the meter after each patient is tested. 2. Cautionary note: If the liquid enters the electronic compartment, the battery compartment, or the cartridge port, the analyzer may be damaged. Changing batteries: Units are currently using rechargeable batteries. The meter needs to stay docked periodically to retain the battery charge. If there is low battery with the rechargeable meters, please dock the meter and then evaluate. If there is continual problem, the battery will need to be replaced by the POCC. The back up meter still holds 9-volt lithium batteries that are obtained from Abbott. K. Calibration: Calibration is automatically performed as part of the test cycle on each cartridge. Operator intervention is not necessary. L. Interferences: An interferent is a substance which, if present at significant levels in the blood specimen being analyzed, will produce an error in the result of the analyte being measured. Analyte Interferent Interferent Concentration Effect on Analyte Result Sodium Bromide 37.5 mmol/l Increase Na Effective Date: 03/28/2017 6

7 ß-hydroxybutyrate Lactate 16 mmol/l 20 mmol/l Decrease Na Decrease Na Chloride Nithiodote(sodium thiosulfate) Acetylcysteine Bromide Lactate Salicylate Thiocyanate mmol/l 10.2 mmol/l 12.5 mmol/l 11 mmol/l 4.34 mmol/l 6.9 mmol/l Increase Na Decrease Cl Increase Cl Increase Cl Increase Cl Increase Cl Glucose Nithiodote Acetominophen Acetylcysteine Bromide Bromide(therapeutic) mmol/l 1.32 mmol/l 10.2 mmol/l 37.5 mmol/l 2.5 mmol/l Increase Cl Increase Glucose Decrease Glucose Decrease Glucose Decrease Glucose ph Per 0.1 ph units below Decrease Gl by 0.9 mg/dl Per 0.1pH units Above Increase glucose by 0.8 mg/dl Oxygen po2 less than May decrease Glucose Hydroxyurea 0.92 mmol/l Increase glucose Thiocyanate 6.9 mmol/l Decrease glucose Nithiodote(sodium thiosulfate) Decrease glucose BUN Thiocyanate Hydroxyurea 24 mmol/l 0.92 mmol/l Decrease BUN Increase BUN Nithiodote(sodium thiosulfate) Decrease BUN Bromide 37.5 mmol/l Decrease BUN Increase star outs(***) Potassium Bromide 37.5 mmol/l Increase K+ results Increase star(***)outs Effective Date: 03/28/2017 7

8 Nithiodote(sodium thisosulfate) Decrease Potassium Troponin hemolysis gross hemolysis decreased ctni received immunoglobulins therapies may have antibodies that interfere with testing may produce erroneous results partially clotted specimens elevated ctni levels or increase in quality check codes hematocrit >65% test imprecision and quality check code errors M. Troubleshooting: In the event of equipment problem, call the POCC at NW at X If not available, call i-stat ( ) for technical help. When there is a discrepancy between the lab and i-stat 6+ value, please use the results of the lab value until an investigation can be completed. N. Communication of Problems: 1. Monthly report will be sent to department representatives identifying any problems found. The unit will be asked to follow up and return to pathology actions taken to resolve problems noted. 2. Additional communications will be sent when problems are identified and need immediate attention. O. Training: To ensure that each operator using the i-stat has been trained and the competency properly documented. Responsibility: Only the POC coordinator or certified trainers have the authority for training and recertification. Policy: Please refer to POC POC Training for Moderate Complex Testing-LBH for detailed information on training. P. Recording and Storage of Data: Effective Date: 03/28/2017 8

9 Results will be viewed on Power Chart as the i-stat is interfaced. Printouts may be attached to result sheets for the doctor to view initially. The interfaced result will become part of the permanent patient record. Q. Critical Values: A critical value indicates a need to take clinical action, including change in therapy or simply repeating at test or submitting a specimen to the clinical lab to verify the original alert value. Point of Care i-stat Reference, Critical and Reportable Ranges for Adults: Values outside the reportable range are not valid on i-stat and should be repeated by the laboratory. Reference ranges apply to whole blood samples tested on the i-stat, and may not match those listed in the computer for in-lab tests. Reference ranges are approved by Pathologist and are from manufacturer s stated ranges. Source: i-stat Procedure Manual Critical values are adapted from multiple sources and reflect LifeBridge Health historical data. Analyte and units Critical Range Low Critical Range High Reference Range Reportable Range Sodium, <121 > mmol/l Potassium, <2.8 > mmol/l Chloride, <76 > mmol/l BUN, mg/dl NA > Glucose, mg/dl <51 > Troponin I, ng/ml NA NA*See note Notification to the provider of critical values are to be documented in the adhoc section of power chart, with name of provider, date, time, test and actual result value that was communicated to doctor. *Lifebridge has established a troponin I reference range of 0-0.1ng/mL for this instrument (Abbott istat). Diagnosis of myocardial infarction requires a documented rise or fall in serial troponin values, with at least one value above the upper reference limit, as well as clinical findings consistent with cardiac ischemia. R. References: i-stat package inserts i-stat System Manual Fundamentals of Clinical Chemistry, N Tietz, Third Edition, Pages , , and Clinical Chemistry Theory, Analysis&Correlation, Kaplan/Pesce, 2 nd Edition, Pages , m , and Pediatric Reference Ranges, 2 nd Edition, Edited by L Steven J. Soldink, Carlo Effective Date: 03/28/2017 9

10 Brugnara, Kurt C. Gunter, Jocelyn M. Hicks. FOOTNOTES: Statland, B.E., Clinical Decision Levels for Lab Tests. Medical Economics Books, Tietz, N.W. Tietz of Clinical Chemistry, second edition, Ed.C.C. Burtis, E. R. Ashwook, W.B. Saunders Company, Philadelphia, Table 41-20, Appendix. Kost Gerald J., Using critical limits to improve patient outcome. Medical Laboratory Observer, March 1993; 25(3): Garth, David M.D., emedicine, Webmd, August 23, 2007, Department of Medicine. Effective Date: 03/28/