5 BEST PRACTICES To Patient Safety. A Practical Guide to Blood Glucose Testing

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Sarah Harrington
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1 5 BEST PRACTICES To Patient Safety A Practical Guide to Blood Glucose Testing

2 In a seven-year hospital study, most errors (91% 97%) were operator-related rather than instrument-related. Nobels F, et al., Feasibility of a quality assurance programme of bedside blood glucose testing in a hospital setting: 7 years experience. Diabetic Medicine, 21: , 2004.

Ensure Calibration and Quality Control Checks are Followed 1 To ensure an accurate result, your glucose monitoring system must have proper calibration and QC.

Daily QC of your glucose monitoring system using the appropriate high and low control solutions is essential for accurate glucose measurement.

3 Ensure Calibration and Quality Control Checks are Followed 1 To ensure an accurate result, your glucose monitoring system must have proper calibration and QC. The meter and test strip should be calibrated on a regular basis. To avoid calibration errors, use a glucose monitoring system that provides simple calibration of test strips. Daily QC of your glucose monitoring system using the appropriate high and low control solutions is essential for accurate glucose measurement. Keeping up-to-date with the latest technology may be a challenge training requires time. With Precision Xtra SmartChip Technology you train once and leave the upgrades to us! The Precision Xtra system, with patented SmartChip Technology, upgrades the Precision Xtra meter so patients receive the latest test strip technology without switching meters no need to retrain! The Precision Xtra meter has a memory that stores a combination of control results, blood glucose and blood β-ketone results, and other monitor information. It also allows you to mark your control solution tests. Precision Xtra Test Strip Upgrades Year Sample Size Test Time µl 20 seconds µl 10 seconds µl 5 seconds SmartChip Technology for Test Strip Upgrades TRAIN ONCE AND LEAVE THE UPGRADES TO US! Daily QC is essential for accurate glucose measurement

2 Use In Date Test Strips To avoid an inaccurate result, ensure that expired test strips are never used.

To avoid using expired test strips, always carefully check the strip s expiration date prior to testing.

Using Precision Xtra test strips that are individually coded for lot number and expiration date can dramatically reduce the

4 2 Use In Date Test Strips To avoid an inaccurate result, ensure that expired test strips are never used. Using fresh test strips is crucial to obtaining an accurate test result. To avoid using expired test strips, always carefully check the strip s expiration date prior to testing. Never assume that a test strip is fresh. Using Precision Xtra test strips that are individually coded for lot number and expiration date can dramatically reduce the chances of using expired test strips. Precision Xtra s individually foil-wrapped test strips have a 24-month expiration period. WITH PRECISION XTRA FOIL-WRAPPED TEST STRIPS, YOU CAN BE SURE THAT THE LAST STRIP IN THE BOX IS AS FRESH, AND ACCURATE, AS THE FIRST. Never assume that a test strip is fresh

5 Prevent Test Strip Contamination 3 Always protect test strips from air, moisture and other potential contaminants. Glucose test strips employ sensitive enzyme chemistry exposure to moisture or air and/or handling can compromise strip performance and accuracy. Using test strips that are individually foilwrapped helps ensure test strips are always fresh and ready to use. Precision Xtra test strips come individually wrapped in foil packages instead of vials. Clinical studies 1 indicate that leaving test strip vials uncapped can significantly affect the accuracy of results. Each Precision Xtra test strip is sealed in an individual foil packet to protect it from air and moisture. Studies 2 show that foil wrapping individual test strips is important for ensuring the accuracy of glucose monitoring in the real world. HOW TO OPEN A PRECISION XTRA TEST STRIP Step 1 Step 2 Step 3 Glucose test strips exposed to air for as little as 2 hours have been shown to cause a -26% bias 3 1. Diabetes 1998; 47 (Suppl. 1): A Diabetes Care 2000; 23: , Diabetes 1998; 47 (Suppl. 1): A6, Diabetes 2002; 51 (Suppl. 2): A Keffer P, Kampa I. Instability of blood glucose test strips in uncapped vials, Diabetes 1998, Vol 47. (Supp 1): A6.

4 Prevent Substance Interference Use test strips that employ GDH-NAD chemistry. Test strips using GDH-PQQ can be affected by icodextrin (Extraneal ) and other maltose-containing medications.

Precision Xtra system with TrueMeasure Technology minimizes interference with glucose-specific GDH- NAD chemistry.

6 4 Prevent Substance Interference Use test strips that employ GDH-NAD chemistry. Test strips using GDH-PQQ can be affected by icodextrin (Extraneal ) and other maltose-containing medications. Test strips using GDH-NAD chemistry minimize potential interference from maltose and other substances. Precision Xtra system with TrueMeasure Technology minimizes interference with glucose-specific GDH- NAD chemistry. Recent industry data indicates the average long-term care resident takes 10 medications per day. 1 Glucose test errors due to interference from common substances in patients blood from acetaminophen to maltose are a common and serious patient safety issue. THE PRECISION XTRA SYSTEM MINIMIZES THE POTENTIAL INTERFERING EFFECTS OF OVER 60 COMMON MEDICATIONS AND SUBSTANCES 2 Exogenous Fluoxetine (Prozac) Salicylic Acid (from Aspirin) Gamma Globulin Acarbose (Glucobay) Gentisic Acid Simvastatin (Zocor) Glutathione (Reduced) Acetaminophen (Tylenol) Gilbenclamide/Glyburide Terfenadine Hemoglobin Amoxicillin Gliclazide (Diamicron) Tetracycline Lactic Acid Ampicillin Glipizide (Glucotrol) Thyroxine Pyruvate Ascorbic Acid (Vitamin C) Ibuprofen (Motrin, Advil) Tolazamide (Tolinase) Triglycerides Captopril (Lopirin) Icodextrin Tolbutamide (Orinase) Urea Cefaclor (Ceclor) Levadopa Warfarin (Coumadin) Uric Acid Chlorpropamide (Diabinese) Methylhydroxyprogesterone Endogenous Sugars Citric Acid Metformin (Glucophage Diabex) Acetoacetate Fructose Diazoxide Methyldopa (Aldomet) Acetone Galactose Digoxin Nifedipine ß-hydroxybutyrate Sucrose Diltiazem (Cardizem) Norethisterone Bicarbonate Maltose Dopamine Omeprazole (Prilosec) Bilirubin, unconjugated Anticoagulants Enalapril (Vasotec) Oxalic Acid Cholesterol Potassium EDTA Ephedrine Quinine Cholic Acid Lithium Heparin Ethanol Ranitidine (Zantac) Citrate ph Ethinylestradiol Salbutamol (Salbumol) Creatinine The brand names listed above are registered trademarks of their respective owners. Extremely high levels of the following substances at the specified concentrations do not affect results: Acetaminophen (Tylenol), 25 mg/dl (1655 µmol/l); uric acid, 24 mg/dl (1.42 mmol/l); ascorbic acid (vitamin C), 4 mg/dl (227 µmol/l); unconjugated bilirubin, 40 mg/dl (684 µmol/l); cholesterol, 500 mg/dl (12.95 mmol/l); triglycerides, 1500 mg/dl (16.95 mmol/l). Do not use during xylose absorption test. Sixty-eight substances, at concentrations much higher than normal or therapeutic levels, had been tested for interference on two previous versions of the TrueMeasure Technology test strip. Differences in the designs between the new test strip and the two previous versions may influence the resistance to interference from 25 of the 68 substances, based on their biochemical and electrochemical properties. Thus, those 25 substances (listed in italic in the table) were tested on the new test strip. Only xylose, at high concentrations found during xylose absorption test, produced significant positive interference. 1. Busintell Report from Knowledge Source, Inc., May Substances in italic were tested with the new TrueMeasure Technology test strip; other substances were tested with previous versions of the TrueMeasure Technology test strip. Xylose may produce falsely elevated glucose results during a xylose absorption test for diagnostic evaluation of malabsorption. Data on file, Abbott Diabetes Care Inc.

Prevent Short Sampling Errors 5 Always ensure an adequate sample of blood is on the strip before running a

Precision Xtra test strips with TrueMeasure Technology help prevent short-sampling.

Precision Xtra test strips are designed to start the test only when enough blood is applied minimizing

To reduce this risk, use a glucose monitoring system with automatic detection of an adequate sample prior

7 Prevent Short Sampling Errors 5 Always ensure an adequate sample of blood is on the strip before running a test. Short sampling is a common cause of inaccurate glucose results which can lead to improper and potentially dangerous insulin dosing. Human error subjective evaluation of the sample size greatly increases the risk of short-sampling. Precision Xtra test strips with TrueMeasure Technology help prevent short-sampling. Each test strip is equipped with a unique fill-trigger to auto-start the test. Precision Xtra test strips are designed to start the test only when enough blood is applied minimizing errors, repeat tests and wasted strips. To reduce this risk, use a glucose monitoring system with automatic detection of an adequate sample prior to test starting. End-fill Top-fill Test Designed to Start Only When Enough Blood Is Applied THE PRECISION XTRA SYSTEM S SIMPLE TWO-STEP TESTING One of the most common problems that can affect glucose monitor reading is applying insufficient blood to the test strip 1 1. FDA: Common Problems with the Use of Glucose Meters.

Simple Testing with Xtra Assurance and Control Xtra-Simple Testing Simple End-fill/Top-fill blood

6 µl sample size Fast 5-second test time 1 Xtra Assurance Unique chemistry minimizes the potential

applied Easy to read display and backlight Xtra Control Each test strip protected with individual foil

8 Simple Testing with Xtra Assurance and Control Xtra-Simple Testing Simple End-fill/Top-fill blood application Small 0.6 µl sample size Fast 5-second test time 1 Xtra Assurance Unique chemistry minimizes the potential interfering effects of many common medications 2 Unique Fill-trigger starts test only when enough blood is applied Easy to read display and backlight Xtra Control Each test strip protected with individual foil wrapping Simple 2-step testing Customer Care: hours a day 7 days a week 1. Assay time dependent on test strip being used. 2. Data on file, Abbott Diabetes Care Inc Abbott. ART17388 Rev. A 07/09

White Paper, Evaluation of WaveSense JAZZ Blood Glucose Monitoring System Analytical Performance to EN ISO 15197:2015 Standard

White Paper, Evaluation of WaveSense JAZZ Blood Glucose Monitoring System Analytical Performance to EN ISO 15197:2015 Standard 7500-10032 Rev F Table of Contents Executive Summary 3 Changes introduced