Lifescan Glucose Meter

Page 1 of 7 Providence Regional Medical Center Everett Lifescan Glucose Meter PRMCE - Lab - Point of Care Testing Procedure 14670 (Rev: 14)Official PRINCIPLE This is a definitive test. Results which are not in the established critical ranges may be acted upon without further confirmation. Results which do not correlate with the patient's clinical condition must be verified by repeat testing and/or testing by the hospital laboratory. Results in critical ranges need to be acted upon as described in the Critical Value Policy (below). Testing can be done only by staff who have been trained to perform this procedure, and who satisfactorily participate in required competency assessment. The test is based on the glucose oxidase method, which is specific for D-glucose. When a small drop of whole blood is applied to a SureStep Pro Test Strip, glucose oxidase on the test strip triggers the oxidation of glucose in the blood sample. Gluconic acid and hydrogen peroxide are produced as a result of this reaction. Peroxidase on the test strip then causes the hydrogen peroxide to react with dyes to produce a blue color in the presence of oxygen. This blue color is visible through the confirmation dot on the back of the test strip - the darker the blue, the higher the glucose level in the blood sample. When the strip is inserted into the SureStep Flexx Bedside Unit, the unit measures the color intensity and reports a plasma-calibrated glucose result. SPECIMEN REQUIREMENTS/PATIENT HANDLING Establish positive patient identification prior to sample collection, by verifying name and birthdate. 1. Blood Collection a. Capillary whole blood samples may be obtained with a lancet from either a fingerstick or a heel puncture (infants only). Ensure adequate blood flow to the puncture site before sticking the finger or heel. b. Gloves must be worn by the person collecting the capillary sample and by any person who assists in holding the patient. c. Proper aseptic technique requires thorough cleansing of the puncture site with soap and water or alcohol wipe. Alcohol must be allowed to dry thoroughly before performing the puncture. d. See Lucidoc 10861 "Blood Drawing Procedures". 2. Type of Specimen a. Fresh whole blood - capillary, venous, or arterial - may be used. Venous and capillary blood may differ in glucose concentration by as much as 70 mg/dl, depending on the time of blood collection after food intake. Factors affecting peripheral circulation may also cause discrepancies between capillary and venous glucose results. b. Anticoagulants such as heparin and EDTA may be used. Do not use preservatives which contain fluoride (gray top tubes). c. Do not use serum or plasma samples. 3. Handling Conditions a. Test the blood sample as close as possible to the time the sample was collected. The test should be performed within 30 minutes of sample collection to minimize glycolysis. If using fresh whole blood in the absence of an anticoagulant, test immediately to prevent clotting from affecting the result. b. When testing whole blood in a tube with anticoagulant, invert gently to mix thoroughly before testing. c. Never dip a SureStep Pro test strip into a tube of blood. EQUIPMENT AND MATERIALS

Page 2 of 7 REAGENTS 1. Lifescan SureStep Flexx Blood Glucose Bedside Unit 2. Cotton or rayon ball. 3. Lancet devices (obtain from Distribution, Product #161967). 4. Soap and water or alcohol wipes 5. Gloves 6. Batteries: 3 size AA cells (obtain from Distribution). 7. Bleach wipes (obtain from Distribution, Product #25232). 8. Soft, lint-free tissue. 9. Cotton swabs. NOTE: Please date all reagents when put into use. Any undated opened QC solutions or Test Strip bottles should be discarded to prevent inadvertent use of outdated materials. 1. SureStep Pro Test Strips (obtain from Distribution, Product #25101). a. Stable for 4 months after opening the vial, or until the manufacturer's expiration date printed on the vial. b. Store tightly capped in their original bottle in a cool, dry place at controlled room temperature below 30 degrees C. Keep away from heat and direct sunlight. Do not refrigerate or freeze. 2. SureStep Pro High and Low Glucose Control Solutions (obtain from Distribution, High product #25102, Low product #25103). a. Stable for 90 days after opening, or until manufacturer's expiration date printed on the bottle. b. Store at controlled room temperature, below 30 degrees C. Do not refrigerate or freeze. STANDARDS AND CALIBRATION 1. Standards - Not applicable. 2. Linearity Verification- see separate procedure. QUALITY CONTROL, DAILY MAINTENANCE, DOCKING, BATTERY REPLACEMENT, AND PROFICIENCY TESTING 1. QUALITY CONTROL a. High and Low Control Solutions are to be tested every 24 hours, or once with each day of use. Also perform QC testing if a patient test has been repeated and the blood glucose results are still lower or higher than expected, when troubleshooting the system, or if the Bedside Unit has been dropped. b. A "QC Lockout" is programmed into each SureStep Flexx Bedside Unit. 24 hours after the previous satisfactory QC run, both levels of control must be tested, and the results must be within established ranges before patient testing can proceed. The time remaining until the next required QC is displayed on the opening screen of the Bedside Units. c. Acceptable ranges are determined by the Point of Care Coordinators, and are programmed into the Bedside Units during the Docking procedure. d. QC and patient results are retained in the Bedside Units until the units are docked. Data is reviewed by the Point of Care Coordinators once each month. A review will be sent to department directors to help maintain proper adherence to QC rules. e. Document all action taken if the results of QC testing did not meet expected ranges by entering appropriate comments, selected from the list on the "Enter Notes" screen. f. If unable to obtain QC values within acceptable ranges, refer to Appendix II, "Troubleshooting Guide". g. If troubleshooting does not resolve the problem, call the Lifescan Healthcare Professional Line at 1-800-524-7226. If the Lifescan personnel determine that the Bedside Unit needs to be replaced, notify the Point of Care Coordinators, whose pager numbers are posted in the Lifescan Bedside Unit tote boxes. 2. DAILY MAINTENANCE a. Clean the Bedside Unit on each day of use, if blood is present, or if an error message prompt you to

Page 3 of 7 3. DOCKING clean the unit. Only 10% bleach and water should be used for cleaning. Do not get water inside the unit. Do not immerse the Unit or hold it under running water. b. Press down on the left side of the test strip holder. This releases the holder allowing you to slide it from the unit. c. Wipe the test strip holder cover and base with a bleach wipe. d. Rinse the test strip holder with water to remove any residual bleach. e. Dry the test strip holder with lint-free tissue. f. Slide the closed test strip holder back into the unit. Push the holder until it clicks into place. g. If needed, wipe the scanner with a soft cloth dampened with water. Docking transfers patient and QC results to a central computer in the laboratory, and transfers information about new lots of test strips and controls to the Bedside Units. a. Bedside Units should be docked daily. b. Place the Bedside Unit in the docking station. The unit does not need to be turned on for this procedure. c. A series of messages is displayed on the screen indicating the status of the transfer. When transfer is complete, the message "Data Transfer Complete" will appear. d. If data transfer was not successful, a message appears giving date and time of failed transmission. In case of failed transmission, try again. e. Contact the Point of Care Coordinators if transmission fails again. f. Patient testing can be performed even if data transfer was not successful. 4. BATTERY REPLACEMENT NOTE: Change batteries when LOW BATTERY message appears on the screen. You may also change batteries if the battery status bar on the Status screen is very low. However, the unit will continue to function properly until the LOW BATTERY message appears. a. DO NOT use rechargeable batteries. b. Press power button to TURN OFF the Bedside Unit. c. Turn the unit over. Open the battery compartment door. d. Remove batteries and dispose of them according to hospital policy. e. Insert three new size AA batteries, matching the + signs on the batteries with the + signs in the battery compartment f. Replace the battery compartment door. g. Turn unit ON to verify power. 4. PROFICIENCY TESTING a. The Point of Care program participates in a Proficiency Testing Program provided by the College of American Pathologists. Samples are received two times per year. b. The Point of Care Coordinators take the proficiency survey samples to each area where Lifescan SureStep Flexx units are located. A staff member who routinely performs patient testing is asked to test the samples on each meter. c. Proficiency testing results are monitored by the Point of Care Coordinators. d. Proficiency testing samples may be run as "Unknown" samples: Select Special Tests from Main Menu. Select Lin/Unkn Test from Special Tests menu. Enter operator ID by scanning barcode on ID badge. Select the Unknown sample which corresponds to the sample to be run.

Page 4 of 7 Test using the same procedure used for patient testing. PATIENT TESTING LIMITATIONS NOTE: If patient is experiencing symptoms which are not consistent with the blood glucose result obtained, and the test procedure described below has been followed: 1) Provide appropriate medical care to treat the symptoms, monitor patient AND 2) Confirm the blood glucose results with a laboratory test. (Order "Glucose Meter Recheck") 1. TESTING PROCEDURE a. Turn the Bedside Unit on. b. Check the battery status to ensure adequate power. Press "Cont.". If a message appears informing you that QC is due, perform QC testing according to the Quality Control Procedure above. c. Select Patient Test from the Main Menu. d. Enter your operator identification by pressing "Scan" and directing the scanning laser across the barcode on your hospital employee identification badge. The scanner should be held 6 to 10 inches from the badge. e. Scan the patient's 10-digit barcoded armband. If the armband does not scan, manually enter the patient's 10 digit encounter number preceeded by an "E". f. Select the test strip lot number from the list displayed. g. Thoroughly clean the patient's finger with alcohol or soap and water. Allow to dry. See Appendix I: "Procedure for Performing Capillary Blood Collections" for proper specimen collection. h. Apply blood to the test strip by carefully touching the pink square on the test strip to the drop of blood. Check the confirmation dot on the back of the test strip to ensure adequate application. i. Insert the test strip into the test strip holder within 2 minutes of applying blood. Push the strip until it comes to a complete stop. j. The result appears on the Bedside Unit LCD in approximately 30 seconds. Press "Menu" to continue testing Press "Enter Notes" and select 1 to 3 comments that correspond to the patient's current situation. Press "OK". See RESULTS REPORTING and CRITICAL VALUES for more information about meter notes (comments.) Remove the test strip and dispose of it in a waste container for contaminated materials. REVIEWING PREVIOUS RESULTS Select "Review Data", then "Patient Results". Enter patient identification number to review results from a particular patient, or "OK" to view all stored results. Results from the last 31 days are viewable in the meter. 1. Preservatives and Interfering Substances a. Whole blood samples containing heparin or EDTA may be used. Do not use preservatives that contain fluoride (gray top tubes). b. Use an adequate amount of blood - just enough to cover the pink test square. Too much blood may cause false high results. If the entire white pad is saturated with blood, discard the strip and apply a smaller drop of blood to a new test strip. Too little blood may cause false low results. If the confirmation dot on the back of the test strip

Page 5 of 7 RESULT REPORTING is not uniformly blue but shows patches of white, you have not applied enough blood. Discard the strip and apply a larger drop of blood to a new test strip. Do not apply a second drop to the same strip. Hematocrit values >60% or <25% can cause false results. High hematocrits may give falsely low glucose results; low hematocrits may give falsely high results. In situations of decreased peripheral blood flow, fingerstick blood testing may not accurately reflect the patient's physiological condition. Conditions in which this might occur include: severe dehydration, as in the hyperglycemic-hyperosmolar state, with or without ketosis; hypotension; shock; or peripheral vascular disease. Highly lipemic blood samples, up to 3000 mg/dl triglycerides, have no significant effect on results, according to Lifescan literature. c. Reportable Range The Lifescan SureStep Flexx Bedside Units will report glucose values in the range between 0-500 mg/dl. Above 500 mg/dl, the result will be displayed as HIGH. The percentage of variation between determinations is greater at lower glucose values. 1. Record results electronically in HED on the VS_I/O_POC charting screen. 2. Meter comments can be added to a glucose result and will appear in ProvCare with the result. Up to three comments can be selected. Comments are added by selecting the "Enter Notes" button that appears when the result is displayed. Comments are then selected from the list that appears by touching the desired comment on the touch screen. 3. Available comments: a. "Procedure Error" (for erroneous results, keeps result from uploading) b. "Will order lab" (use with "HIGH" result to indicate lab glucose will be ordered) c. "Pt symptomatic" (use with obviously hypoglycemic patients, repeat not required) d. "Will repeat test" (use when you are going to repeat the test for any reason) e. "Use this result" (use if this is the result that will be charted in HED) f. "Use prev result" (use if the previous result is the one that will be charted in HED) RESULTS IN PROVCARE (INTERFACE INFORMATION) 1. The meter must be docked and successfully downloaded before the result will appear in ProvCare, on the Lab results page under the "Point of Care" heading. 2. Results repeated within 10 minutes will be held up on the interface until Point of Care Coordinator uploads one or the other (based on comment attached to the result). a. In the event the repeated results agree within 10%, or 5 mg/dl (whichever is larger), and no comments are attached, the second result will be uploaded. b. Both results will not be uploaded if they agree within 10% of each other. c. This will generally occur the next business day. 3. Only results with a proper patient ID will cross the interface. 4. Results with the comment "Procedure error" will not cross the interface. CRITICAL VALUES 1. For patients less than one year old: Critical low: < 50 mg/dl

Page 6 of 7 Critical high: >150 mg/dl 2. For all other patients: Critical low: Critical high: < 40 mg/dl > 500 mg/dl CRITICAL VALUE POLICY : For low criticals (<35 for newborns; <40 for all others): For the patient without obvious hypoglycemic symptoms 1) Check the confirmation oval. Is it uniformly blue? If not, enter note "Procedure Err" If confirmation oval is OK, enter "Will repeat " 2) Repeat the test on the glucose meter. Enter note :"Use this reslt" for second result if that is the result that is going to be charted in Electronic Health Record. If the first result is the one that will be charted, select note: "Use prev reslt" For the patient with obvious hypoglycemic symptoms 1) Check the confirmation oval. Is it uniformly blue? If not, enter note "Procedure Err" and repeat the test on the meter. If the oval is OK, enter note "Pt Symptomatic". ( There is no need to repeat the test.) For high criticals greater than 500: an immediate repeat on the meter and/or a lab glucose should be obtained. If repeating, enter "Will repeat" Repeat the test, if the result is a number less than 500, enter "Use this reslt" A lab draw must be ordered if the repeat is still greater than 500. (order "Glucose Meter Recheck") Follow Nursing Protocol for appropriate treatment of patient and notification of physician. REFERENCE RANGES Birth to 3 days: 40-90 mg/dl 4 days to 50 yr: 60-110 mg/dl Older than 50 yr: 60-125 mg/dl

Page 7 of 7 REFERENCES 1. Marks B, Dawson A. Rapid stick method for determining blood glucose concentrations, British Medical Journal. 1965;1:293. 2. Beaser RS, Hill JVC., Joslin Guide to Diabetes. New York: Simon oand Schuster; 1995 (p. 158-159; p. 168-169). 3. Clark WI, Cox D, Gonder-Frederick IA, Carter W, Pohl SI., Evaluating clinical accuracy of systems for selfmonitoring of blood glucose, Diabetes Care. 1987; 10:622-628. 4. Sacks DB in "Carbohydrates", Burtis CA, Ashwood ER (ed). Tietz Text-book of Clinical Chemistry. Philadelphia: WB Saunders Company; 1999. 5. Rushakoff RJ, Lewis SB, Case of Pseudohypoglycemia (letter), Diabetes Care. 2001; 24:2157-2158. 6. Atkin SH, et al. Fingerstick-glucose determination in shock. Annals of Internal Medicine. 1991; 114:1020-1024. 7. Sylvain HE, et al. American Journal of Critical Care, 1995;4:44-48. 8. Wickham NWR, et al. Practical Diabetes. 1986;3:100. 9. Cohen FE, et al. Diabetes Care. 1986;9:320-322. 10. National Committee for Clinical Laboratory Standards, Interference Testing in Clinical Chemistry; Proposed Guideline, NCCLS Document EP7-P (ISSN 0273-3099). 1986. 11. Tang Z, Du X, Louie RF, Kost GJ. Effects of drugs on glucose measurements with handheld glucose meters and a portable glucose analyzer, American Journal of Clinical Pathology. 2000;113:75-86. 12. Dorman HR, Sonheimer JH, Cadnapaphornchai P. Mannitol-induced acute renal failure. Medicine. 1990; 69:153-159. 13. American Diabetes Asssociation, "Standards of Medical Care for Patients with Diabetes Mellitus, " (Position Statement), Diabetes Care. 2002;25 (suppl 1): S33-S49. 14. Tietz, NW Clinical Guide to Laboratory Tests, 2nd ed. 1990;246. 15. NCCLS, Evaluation of Precision Performance of Clinical Laboratory Methods and Diagnosis, ST. Louis: The C.V. Moby Company; 1980:210-249 16. Lin YI, Dietzler DN, Smith CH. Stabilization of blood glucose by cooling with ice, an effective procedure for preservation of samples from adults and newborns, Clinical Chemistry. 1976 Dec; 22:2031-2033. 17. Roberts WR. A tale of two PT materials CAP Today. 1995;9:65-66. 18. Lifescan SureStep Pro Test Strip Product Insert SUPPLEMENTAL MATERIALS 1. SureStepPro Bedside Unit Operator's Guide. 2. Nursing Practice Manual Policies. 3. Appendix I: Capillary Blood Collection Guide. 4. Appendix II: Troubleshooting Guide. Referenced Documents Reference Type Title Notes Documents referenced by this document Applicable Documents Urinalysis - Ames Clinitek 100 Operation Documents which reference this document Applicable Documents Hyperglycemia/Diabetic Ketoacidosis Applicable Documents Hypoglycemia Signed by ( 06/03/2010 ) Gayle Tjersland Effective 06/03/2010 Document Owner Tjersland, Gayle Paper copies of this document may not be current and should not be relied on for official purposes. The current version is in Lucidoc at https://www.lucidoc.com/cgi/doc-gw.pl?ref=pemc_p:14670.