Clinical Significance/Purpose

Clinical Significance/Purpose

CLINICAL SIGNIFICANCE/PURPOSE

The Hemocue Glucose 201 system consists of a disposable microcuvette containing dry reagent and a factory-calibrated analyzer. It is intended for monitoring purposes to guide patient therapy during the perioperative period at Orthopaedic Institute Surgery Center. This policy provides instruction to staff and anesthesia providers to ensure safe and accurate point of care blood glucose testing using the Hemocue Glucose 201 system.

PRINCIPLE

The Hemocue Glucose 201 Glucose analyzer has been developed to provide immediate measurement of blood glucose. The analyzer is a photometer that uses a dual wavelength for glucose measurement and turbidity compensation. The red blood cells are broken apart to measure the glucose content in the red cells and blood plasma. It provides laboratory quality analysis of glucose in whole blood, easily, quickly and conveniently. Utilization of a conversion factor allows the measured whole blood result to be displayed as a plasma equivalent glucose value.

COMPETENCY

Competency evaluations will be conducted during orientation/in-service and annually thereafter for OISC staff performing testing. The competency records will be maintained in personnel files in the office of the Administrative Director.

Anesthesia providers will be given an orientation/in-service on the HemoCue Glucose 201 system before operating/performing patient testing.

SPECIMEN REQUIREMENT

5 ul of capillary blood from the finger (finger stick)

REAGENTS

  1. Hemocue Glucose 201 Microcuvettes
  2. Store unopened microcuvettes below 46° F, including in the freezer.
  3. Microcuvettes stored in the freezer must be allowed to reach room temperature 59-86° F (approximately 30 minutes) before analysis.
  4. The individually packaged microcuvettes can be stored at room temperature 59-86° F for up to 3 days.

2. Eurotrol Glucotrol-AQ Liquid Control Solutions

  1. 2 levels: Low and High
  2. Store at 35-46° F.
  3. Stable for 30 days after opening. Date each bottle when opened with new expiration date.
  4. Do not use control solutions past the expiration date on the package label.

3. To obtain accurate results, you must follow the Package Insert instructions. The Package Insert instructions should be checked with each new lot/shipment for changes in the manufacturer’s instructions.

SUPPLIES/MATERIALS

  1. HemoCue 201 Glucose Analyzer
  2. Individually packagedHemoCue Glucose 201 Microcuvette
  3. 4 AA batteries, 1.5 V
  4. Adaptor - HemoCue HCA01
  5. HemoCue Glucose 201 Operating manual and Quick Reference Guide
  6. HemoCue Cleaner or cotton tipped applicator moistened with alcohol or water
  7. Adult lancet – BD Microtainer – Contact activated lancet
  8. Alcohol prep pads
  9. Gloves
  10. 2x2 gauze
  11. Adhesive bandage (if needed)
  12. Germicidal wipe

PRECAUTIONS

  1. A disposable single-use, auto disabling lancet is the only device that should be used when performing finger sticks at OISC. Never reuse lancets. When performing a finger puncture, direct the blood away from the face. Avoid squeezing the puncture site to obtain an adequate amount of blood.
  2. If possible, the glucose meter should be assigned to an individual person while at OISC.
  3. The device must be cleaned and disinfected after every use with a facility approved germicidal wipe.
  4. NEVER put analyzer or supplies on patient or patient’s linens.
  5. Treat all specimens as capable of transmitting disease. Always wear gloves when performing finger sticks.
  6. Change gloves if they become visibly contaminated with blood.
  7. Never access clean supplies with contaminated gloves.
  8. When test is complete, remove gloves and perform hand hygiene.
  9. Discard used lancets and microcuvettes in appropriate sharps container.
  10. Immediately clean and disinfect any surfaces that may have become contaminated with blood or body fluids with approved germicidal wipes.

QUALITY CONTROL

  1. Self-test/Calibration

The Hemocue Glucose 201 Analyzer has an internal quality control, a “selftest.” Every time the analyzer is turned on, it will automatically verify the performance of the optronic unit. It does not require user calibration.

  1. Liquid Controls
  1. The Low and High controls must be run on all meters in use once every 24 hours.
  2. In addition perform control checks:
  3. Whenever the meter is dropped or damaged,
  4. After a battery change,
  5. Anytime the meter or microcuvette performance needs to be evaluated.
  1. Control Test Procedure:
  2. Remove the Low and High controls from the refrigerator.
  3. Check the expiration date written on the vials and the date printed on box.
  4. Discard the vials if outside of the expiration date and use new vials.
  5. Allow the vials to stand for 15 minutes at room temperature (59-86°F).
  6. Gently mix the vials by inverting 8-10 times before sampling.
  7. Using the Low OR High control, dispense a drop of the control material onto nonporous surface and fill the cuvette according to the manufacturer’s instructions. Do not fill the cuvette from the vial. Place the cuvette in the analyzer for immediate analysis.
  8. Wipe any excess material from the vial and the cap with a clean tissue and recap the vial tightly.
  9. If the Low control was used first, repeat the test with the High control, or vice versa.
  10. If a new control vial(s) were used, write the expiration date on the vial(s).
  11. Return the control vials to the refrigerator after use.
  12. Document results on the HemoCue Glucose 201 QC Log.
  1. Expected ranges:

1)Low: 61-99 mg/dL

2)High: 286-378 mg/dL

  1. If the control does not perform as expected, review the instructions for use of the instrument to see if the test was performed correctly. Check the expiration date and storage conditions for the control and cuvettes. Repeat the test. If the control still does not perform as expected, contact technical assistance.

PREPARING THE ANALYZER FOR TESTING

  1. If A/C power is available, plug the power adapter into the power inlet at the back of the analyzer.
  2. If A/C power is not available, install 4 type AA batteries in the battery compartment.
  3. Pull the cuvette holder out to the loading position.
  4. Press and hold the on/off button until the display is activated.
  5. The display shows “SELFTEST” and the version number of the program, after which it will say “GLU”. During the “SELFTEST” the analyzer will automatically verify the performance of the optronic unit.
  6. After 15 seconds the display will show “READY” and three flashing dashes. This indicates that the analyzer is ready for use.

PATIENT TESTING PROCEDURE/INTERPRETATION OF RESULTS

  1. Gather and arrange supplies and equipment (contact activated lancet, alcohol prep pad(s), gauze, protective barrier (i.e. paper towel), microcuvette, and Hemocue 201 analyzer).
  2. Properly identify patient according to OISC policy.
  3. Prepare the meter to receive blood sample according to the manufacturer’s instructions.
  4. Check the expiration date of the microcuvette and remove from packaging.
  5. Perform hand hygiene and don gloves.
  6. Choose puncture site
  7. Fingertip of middle or ring finger
  8. Do not puncture the tip or extreme side of the finger nor the pinkie finger
  1. Clean selected site with alcohol prep pad and allow area to air dry or wipe with clean, dry gauze.
  1. Perform the puncture
  1. It may be necessary to hold finger being punctured in dependent position while gently massaging finger toward the puncture site.
  2. Remove cover of lancet device.
  3. Obtain blood sample by placing the lancet device against lateral side of finger and pushing down on the device.
  4. Wipe away the first 2 drops of blood with clean gauze. The third drop of blood will be used for testing.
  5. When the blood drop is large enough, fill the microcuvette in one continuous process by holding the microcuvette opposite the filling end and bringing into contact with the capillary specimen. The microcuvette should be completely filled by capillary action.Do NOT refill.
  6. Wipe off excess blood from the outer surface of the microcuvette with gauze, being careful not to touch the open end of the microcuvette.
  7. Look for air bubbles in the filled microcuvette. If present, take a new sample. Small bubbles around the edge can be ignored.
  8. Repuncture if a large enough drop does not form.
  1. Place the microcuvette in the cuvette holder and start measurement as soon as possible but no later than 40 seconds after filling the microcuvette by gently pushing the cuvette holder to its measuring position.
  2. During the measurement, an hourglass symbol will be shown in the display.
  3. Test results will display on the meter in 40 to 240 seconds.
  4. Apply clean gauze to puncture site and apply self-adhesive bandage if necessary.
  5. Turn meter off. If operating on battery power, the analyzer will automatically turn off after approximately 10 minutes.
  6. Pull the cuvette holder out to its loading position and remove the cuvette.
  7. Discard microcuvette and lancet in sharps container and dispose of other supplies in appropriate receptacle.
  8. Remove gloves and perform hand hygiene.
  9. Document blood glucose level in patient’s record and on HemoCue Glucose 201 QC Log.
  10. Clean the exterior surface of the analyzer with germicidal wipe.

RESULTS

  1. The Hemocue 201 analyzer will display results from 0-444 mg/dL.
  2. All glucose results > 444 mg/dL will display as “HHH”.
  3. If results are unexpected or do not match the patient’s condition, repeat the test and/or verify results with a lab run glucose and consult with anesthesiologist.

EXPECTED VALUE

Adults fasting plasma blood glucose: 74-106 mg/dL.

RECORDING RESULTS

  1. Preoperative finger stick blood glucose levels will be recorded on the Pre-operative Assessment sheet.
  1. Intraoperative finger stick blood glucose levels will be recorded on the Anesthesia Record by the anesthesia provider.
  2. Postoperative finger stick blood glucose levels will be recorded on the Post Anesthesia Care Record.
  3. All finger stick glucose levels will also be recorded on the HemoCue Glucose 201 QC Log.

ANALYZER MAINTENANCE

  1. Cuvette Holder
  2. The cuvette holder should be cleaned daily.
  3. Pull the cuvette holder out to the loading position.
  4. While pressing the catch, carefully rotate the cuvette holder sideways in open position as far as possible to the left.
  5. Remove the cuvette holder from the analyzer.
  6. Clean the cuvette holder with an alcohol prep pad.
  7. Wait 15 minutes before replacing the cuvette holder and using the analyzer. Make sure the cuvette holder is dry before inserting into the analyzer.
  1. Optical parts
  1. Dirty optical parts may cause an error code. The optical parts should be cleaned when directed to do so in the Troubleshooting Guide in the Operating Manual.
  1. With the cuvette holder removed from the analyzer, push the Cleaner into the opening of the optic unit, as far as possible. Move from side to side and push in and pull out 5-10 times.
  2. If the Cleaner is stained, repeat with a new Cleaner.
  3. As an alternative to the Cleaner, a lint free cotton swab moistened with alcohol or water may be used. Make sure it is not too wet or dry. Use a dry swab to wipe away excess liquid in the optic hours after cleaning with a moistened swab. To avoid scratches on the cover glasses, only the cotton part of the swab should come in contact with the cover glasses.
  4. Wait 15 minutes before replacing the cuvette holder and using the analyzer. Make sure the cuvette holder is dry before inserting.

LIMITATIONS

  1. The controls and microcuvettes are for In Vitro Diagnostic use only.
  2. The microcuvettes are only to be used with the HemoCue Glucose 201 Analyzer.
  1. The measurement needs to be started no later than 40 seconds after filling the microcuvette.
  2. If air bubbles are seen in the optical eye of a filled microcuvette, the microcuvette should be discarded and another sample taken for analysis.
  3. The HemoCue Glucose 201 analyzer with plasma conversion multiplies the obtained whole blood glucose value by a factor and displays a plasma equivalent glucose result. Since this factor is based on the relationship between plasma and whole blood at normal hematocrit, care should be taken when evaluating results in situations where the hematocrit may be extreme. The difference is however minimal.
  4. The following substances have been tested without interfering with the system: Ascorbic Acid, Acetone, Acetylsalicylic Acid, Bilirubin, Creatinine, Urea, Acetaminophen, Dopamine, Ephedrine, Ibuprofen, L-Dopa, Methyldopa, Tetracycline, Tolazamide, Tolbutamide, and Uric Acid.
  5. The measured blood glucose value at high concentrations of Glucosamine (>90 mg/dL) should be interpreted with caution.
  6. The measured blood glucose value of lipemic specimens (triglyceride, cholesterol, and intralipid) should be interpreted with caution.
  7. The measured blood glucose value of whole blood samples with >5% Methemoglobin concentrations should be interpreted with caution.

TROUBLESHOOTING GUIDE

The Troubleshooting Guide is located in the Operating Manual. The Troubleshooting Guide provides the explanation and action for the following:

  • “ERROR” codes 900-930
  • “HHH” results
  • No, or erroneous, characters on the display
  • Low battery symbol displayed
  • Display doesn’t switch from “SELFTEST” to “READY” or from “READY” to measuring symbol
  • Out of range control measurements
  • Patient measurements are higher or lower than anticipated

If the problem cannot be resolved by following the Troubleshooting Guide, call the regional HemoCue representative or the customer service number located on the back of the analyzer.

REFERENCES

  1. HemoCue Glucose 201 with Plasma Conversion Operating Manual.
  2. Eurotrol Glucotrol-AQ package insert.
  3. HemoCue Glucose 201 Microcuvettes package insert.
  4. The Centers for Disease Control and Prevention.Infection Prevention during Blood Glucose Monitoring and Insulin Administration. May 2, 2012.

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