AppHealthCare Appalachian District Health Department Policy and Procedure
Policy Name: Section 1100 Approved Date: Laboratory Procedure 12/2008 Policy Topic: Chapter 1112 Revision Date: HemoCue Glucose 201 02/20/2017 PURPOSE: This procedure establishes guidelines for the use of the HemoCue Glucose 201 instrument. This system provides analysis of glucose in whole blood. This policy will also ensure that results are documented and reported in a timely manner to assist clinical staff in providing quality care to our clients. SCOPE: This procedure applies to Appalachian District Health Departments laboratory personnel who have been approved to perform HemoCue Glucose testing and successfully maintain competency. MATERIALS: Reagents Storage Supplies Equipment o 2‐8 C Use HemoCue Alcohol wipes HemoCue within 30 days Gauze Glucose 201 Glucose 201 of opening Microcuvettes Analyzer Blood lancets, 18‐30 C (room needles, temp) for up to syringes, and 3 days. blood‐ Quality Must be stored collection Control‐ in the tubes Eurotrol refrigerator at Hydrophobic glucoTrol‐AQ 2‐8°C. material such Level 1‐Low Controls are as Para film® Level 3‐High stable until the Disposable expiration date transfer on the outer pipettes box and vial. suitable for the After opening, transfer of GlucoTrol‐AQ is blood from stable for 30 vacuum tubes days when PPE stored at 2‐ Bio‐hazard and 30°C. “sharps” containers 1 Occult Blood
WARNINGS/PRECAUTIONS: Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions" and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. SPECIMEN:
Capillary or venous whole blood may be used. Appropriate anticoagulants in solid form, (e.g. EDTA and heparin) and glycolysis inhibitors (e.g. sodium oxalate, sodium fluoride, and potassium oxalate) may be used. Glycolysis is a major concern in all glucose measurements. To minimize the effect of glycolysis, the blood sample should be tested as soon as possible after collection. Samples collected in the recommended anticoagulants should be analyzed within 30 minutes. Mix all anticoagulated samples thoroughly on a mechanical mixer for at least 2 minutes or by inverting the tube at least 8‐10 times prior to measurement. Specimens that have been refrigerated must be allowed to reach room temperature (18‐30°C, 64‐86°F) and mixed well, prior to analysis. In cases of severe hypotension and peripheral circulatory failure, glucose measurement from capillary samples may be misleading. In such circumstances, it is recommended that glucose analysis be made using venous or arterial whole blood. For proper specimen collection, refer to the “ADHD Venipuncture Procedure” and/or “ ADHD Capillary Collection Procedure” located in the ADHD Policy and Procedure Manual.
QUALITY CONTROL: Controls must be tested each day of use. Values of low and high controls are lot number dependent and can be found on the package insert with each set of controls. Controls may be used until the manufacturer’s expiration date or thirty (30) days from the date opened, whichever is shorter. Write date opened on the control vials and complete the control information on the Control Log. Quality Control Procedure: Step: Action: Details: Allow the vial to stand for 15 minutes at room 1. temperature 15‐30°C. Mix the vials by rolling gently in between hands and This is important to 2. gently inverting vials 8‐10 times. When thoroughly obtain reproducible 2 Occult Blood
Step: Action: mixed, testing can begin. Press and hold the on/off button until the display is activated. The display shows “SELFTEST” and the version number of the program, after which it will have 4. “GLU”. During the “SELFTEST” the analyzer will automatically verify the performance of the optronic unit. After 15 seconds, the display will show “READY” and 5. three flashing dashes. 3.
Pull the cuvette holder out of the loading position. Place a drop of each control material on a piece of 7. plastic film. Using the drop for the low control, fill the cuvette in 8. one continuous process. 6.
Details: results.
This indicates that the instrument is ready for use. Do NOT refill.
Being careful not to touch the open end of the cuvette. If present, take a new sample. Small 10. Look for air bubbles in the filled cuvette. bubbles around the edge can be ignored. This must be Place the filled cuvette in the cuvette holder. performed within 40 11. seconds after filling the cuvette. During the Push the cuvette holder into the analyzer. measurement, an 12. hourglass will be shown in the display. The result will 40 – 240 seconds, the glucose value of the sample is remain on the 13. displayed. display if the cuvette holder is in the measuring position. Verify that value is Record results on the HemoCue Glucose Control Log within acceptable 14. limits. 15. Discard the microcuvette in the sharps container. 9.
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Wipe off excess blood from the outer surface of the cuvette with lint free tissue
If results are not within the expected ranges: Step: Action: Repeat testing ‐Remix control bottle and obtain new drop. 1 If: Then: Repeat passes Continue with patient testing 2 Repeat fails Discontinue patient testing Check expiration dates of reagents. Open new bottles of reagents Clean instrument 4 No patient testing will be performed until QC is within range. Expected results are lot number dependent. Refer to the 5 manufacturer’s package insert for values. Record all problems and steps taken to correct problem on the 6 corrective action log.
PROCEDURE: Step: Action: Details: Obtain a capillary specimen per established protocol. See “Capillary 1. Collection Procedure” Using a dry gauze pad or other lint free tissue, wipe 2. away the first two or three large drops of blood. Apply light pressure as needed until another drop of Avoid “milking of blood appears. finger” 3. This can dilute specimen Hold the cuvette opposite the filling end and introduce Make sure the drop the cuvette tip into the middle of the drop of blood. of blood is large 4. enough to fill the cuvette completely. Allow the cuvette to fill in one continuous process Do NOT refill a 5. partially filled cuvette. Wipe off any excess blood from the outside of the Do NOT touch the 6. cuvette using a clean, lint free tissue. open end of the cuvette Visually inspect the cuvette for air bubbles in the If bubbles are 7. optical eye. present, discard the cuvette 4 Occult Blood
Step: Action:
8.
9.
Place the filled cuvette into the cuvette holder and gently slide the holder into the measuring position. During measurement, an “hourglass” symbol will be shown on the display screen. After 40‐240 seconds, the glucose value of the sample will be displayed.
10.
Record the results on the HemoCue Glucose Patient Log and in the computer. Pull the cuvette holder out to the loading position. Remove the cuvette and discard it in an appropriate biohazard container. 12. 11.
13.
14.
For venipuncture samples collect an EDTA tube per established protocol.
Place a well‐mixed drop of blood onto a plastic film using a bulb pipette.
Place a drop of blood onto a piece of plastic film using a disposable pipette. 16. Proceed as in Steps 4‐12 of the section above 15.
Details: The filled cuvette must be inserted into the analyzer within 40 seconds after it has been filled The results will remain on the display if the cuvette holder is in the measuring position. When the display reads “READY” with three flashing dashes, the analyzer is ready for the next measurement Refer to the “Venipuncture Procedure” for collection details. Mix the sample by gently inverting at least ten times.
RESULTS REPORTING: Results are recorded in mg/dL on the paper lab requisition and in EMR. Values above 444 mg/dl will be displayed as HHH and should be confirmed with another laboratory method. REFERENCE RANGES:
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FASTING PLASMA BLOOD GLUCOSE, ADULTS IS 74‐106 mg/dL. For diagnosis of diabetes mellitus, follow the recommendations of American Diabetes Association (ADA); Fasting plasma blood glucose, capillary or venous: >126 mg/dL.
PANIC/CRITICAL VALUES: < 50 mg/dl > 200 mg/dl > 300 mg/dl for known diabetics NOTE: All panic values are to be repeated and provider notified. See “Panic Value Policy” for detail instructions on reporting panic values. MAINTENANCE: Daily Turn off the analyzer. The display should be blank. Pull the cuvette holder out to the loading position. Use a pointed object to carefully press the small catch positioned in the upper right corner of the cuvette holder. While pressing the catch, carefully rotate the cuvette holder towards the left as far as possible. Carefully pull the cuvette holder away from the analyzer. Clean the cuvette holder with an alcohol prep pad. Allow the cuvette holder to dry before replacing the cuvette holder. Document on the HemoCue Cleaning Log. (Attachment III) PRN Moisten a cotton tip swab with distilled water. Push the swab into the opening of the cuvette holder. Pull out and push in 5 – 10 times. If the swab is stained, repeat with a new swab. No further cleaning is required if the swab remains clean. Wait 15 minutes before replacing the cuvette holder and using the analyzer. The cover may be cleaned with alcohol or a mild soap solution. LIMITATIONS: In case of severe hypotension or peripheral circulatory failure, glucose measurement from capillary may be misleading. In such circumstances, it is recommended to use venous or arterial blood. If air bubbles are seen in the optical eye of a filled cuvette, the cuvette should be discarded and another sample taken for analysis. Caution should be taken not to hold the cuvette by the filling end, which may result in smearing the optical eye. Care should also be taken in wiping off the outside of the cuvette and the optical eye. Ascorbic Acid, Acetylsalicylic Acid, Bilirubin, Creatinine, Urea, Acetaminophen, Dopamine, Ephedrine, Ibuprofen, L‐Dopa, Methyldopa, Tetracycline, Tolazamide, Tolbutamide and Uric Acid do not interfere with the HemoCue Glucose 201 system.
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The measured blood glucose values at high concentrations of grossly lipemic, high concentrations of Glucosamine, samples with abnormal Methemoglobin concentrations should be interpreted with caution. The HemoCue Glucose 201 analyzer multiplies the measured whole blood value by a factor and displays a plasma equivalent result. Please note that this factor is based on the relationship between plasma and whole blood at normal hematocrit. When comparing Glucose 201 results from samples with extreme hematocrits to a method that measures plasma directly, the results may not correlate as excepted. This difference is however minimal. TROUBLESHOOTING: Refer to the Troubleshooting Guide in the Operator’s Manual. For unresolved problems, contact the Laboratory Manager or HemoCue U.S. Technical Services at 1‐800‐426‐7256. REFERENCES: HemoCue AB. Operator’s Manual. HemoCue AB Box 1204, SE‐262 23 Angelholm Sweden; phone +46 431 45 82 00 Pamphlet: HemoCue Glucose 201 Microcuvette and analyzer; HemoCue, Inc. 40 Empire Drive, Lake Forest, Ca. 92630; 800‐323‐1674 Eurotrol GlucoTrol‐QA Package Insert. Eurotrol Inc. 563 Main Street, Bolton, MA 01740. Revision 5/26/2009. 7 Occult Blood
AppHealthCare APPALACHIAN DISTRICT HEALTH DEPARTMENT GLUCOSE TESTING HEMOCUE 201 ANALYZER Annual Review by Laboratory Director/Designee Prepared by: Brenda Abbott, Date: 12/2008 Revised by: Tracey Shives, MT (ASCP) Date: 8/19/2011 Revised by: April Sutton Date: 1/6/2017 Revised by: Dana Larned,MA Date: 2/20/17 Approved by: Patty Atwood, MT (ASCP) Date: 8/19/2011 Laboratory Director Approved by: _____________________ Date: _________ Laboratory Director Approved by: _____________________ Date: _________ Laboratory Manager Approved by: _____________________ Date: _________ Technical Consultant
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