INTENDED USE: The Precision XceedPro Blood Glucose  and β-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (D-glucose) in fresh capillary whole blood (fingertip) samples. The Precision XceedPro System is for home (lay user) or professional use. The Precision XceedPro System is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs.

Healthcare professionals may also use the product for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes after collection.

PRINCIPLE OF MEASUREMENT: When the blood sample is applied to the test strip, the glucose in the blood reacts with the chemicals on the test strip, producing a small electrical current depending on the amount of glucose in the blood sample.

EQUIPMENT AND MATERIALS:

A.     Precision XceedPro System Components

1. The Precision XceedPro System includes the following items:
2. Monitor
3. Port Protector
4. Blood Glucose Test Strips
5. Control Solutions
6. Calibration Verification Controls
7. Carry Case
8. Docking Station
9. Data Management System
   

B.   Reagent: Precision XceedPro Test Strips. Test strips and control solutions are obtained from the Laboratory.  Store reagents and test strips at room temperature.  The test strips work by first inserting the contact bars into the monitor. Then the sample is applied to the target area, covering both the working electrode and the reference electrode. This area is coated with enzymes that react in the presence of glucose to make a small electric current. This current is passed through the strip to the contact bars and the monitor, which calculates a glucose result. The reagent  of each test strips contains:  

C. Controls: Controls are to be run each day of use. If control testing has not been performed in the last 24 hours prior to patient testing, then perform low and high control testing prior to patient testing.

Capillary whole blood, arterial whole blood, or venous whole blood can be tested using the Precision PXP.. See Venipuncture (Custom Lippincott procedure).  NOTE: Arterial blood: use only fresh whole blood samples.
Collect the capillary blood using a lancing device and an appropriate technique (see Venipuncture, Custom Lippincott procedure).
Avoid squeezing the puncture site excessively.
Apply the drop of blood directly to the target area of the test strip, covering the entire test area.
Venous blood sample should be collected in a heparin or EDTA tube, ensuring that the test tube is completely filled. Test the sample within 30 minutes after collection.
Invert the tube several times before testing the sample.
Caution should be taken to clear arterial lines before blood is drawn and applied to the test strip.

IMPLEMENTATION PROCEDURE:

1. Use two identifiers to identify patient, according to lab specimen collection procedure. Explain procedure to patient.
2. Follow Universal Precautions, and wear gloves. See Skin puncture procedure located elsewhere in this procedural manual.
3. Check instrument for contamination. If contaminated, clean with mild detergent and water. Ammonia and alcohol based cleaners should be used. Acceptable cleaning solutions include: Sani-Cloth HB, Sani-Cloth Plus, and Super Sani-Cloth
4. Press "On/Off" to turn on monitor.
5. Press "1" to select Patient test.
6. Press Scan, and scan operator’s employee ID badge barcode, or enter assigned operator number on the keypad as operator ID and press enter.
7. Press Scan to scan the patent wristband bar code for patent ID. If a barcode is difficult to scan, manually enter patients visit number via the keypad number starting with  “V” Omit leading V000 and manually enter the 12-digit visit number. Continue pressing the scan key until patient ID has been verified to ensure that correct ID number was entered. (When scan key is released the meter window will proceed to next screen. If the Scan key was released before the patient’s ID number could be verified, then press the” Clear” key. The “Clear” key will bring you to previous the previous step)
8. Press “Scan” to scan the test strip barcode.
9. Insert the test strip into the test strip port until it stops
10. Use fresh whole blood samples. If performing a capillary puncture, wash finger and/or hand with soap and water, then clean the finger with an alcohol wipe. Make sure no alcohol remains on the puncture site. Dry with gauze pad. Collect the capillary blood using a lancet device. Avoid squeezing the puncture site excessively. (Contaminated with even a trace of food particles on the finger can increase the test results; alcohol left on the finger can dilute the blood sample and decrease the test result
11. Apply blood sample directly to the tip of the test strip.
12. Wait for the monitor to analyze the sample and display the test result.
13. Enter a comment code if needed.  
14. Remove test strip from monitor when testing is complete.
15. Dispose of bio-hazardous materials according to protocol.  Place the glucose meter as soon as possible in the docking station. When meter is docked in a docking station, the result of the patient’s whole glucose test will be recorded in Meditech. The test is not complete until meter is placed in docking station.
16. The test result may be verified with a repeat test. Only the last test result will be sent to meditech if the repeat is done within five minutes of the initial testing.
17. All results less than 50 mg/dl but more than 20 mg/dl from the Precision PXP glucose meter must be repeated immediately on the Precision PXP glucose monitor in order to verify the low result.
    1. The repeat of the test on the glucose meter is a requirement.  If the two POCT whole blood glucose results are within +/- 15 mg/dl then no glucose test done by the Laboratory glucose is required.  The last of the repeated results will be recorded in Meditech..
    2. If a variation greater than +/- 15 mg/dl is obtained from the glucose meter, then a STAT lab glucose test must be ordered in Meditech. The whole blood glucose result must be verified by a laboratory glucose test.
    3. The only exception to the repeat requirements is: if the whole blood glucose test is a follow up of a previous low verified glucose test result.
18. All results greater than 300 mg/dl but less than 500 mg/dl from the Precision PXP glucose meter must be repeated immediately on the Precision PXP glucose monitor in order to verify the result. Make sure the finger used for testing is clean and dry prior to testing.
    1. The repeat of the test on the glucose meter is a requirement. If the two POCT whole blood glucose results are within +/- 35 mg/dl then no Lab glucose is required. The last of the repeated results will be recorded in Meditech.
    2. If a variation greater than +/- 35mg/dl is obtained from the glucose meter then a STAT Lab glucose test must be ordered in Meditech. The whole blood glucose result must be verified by a Lab glucose test.
    3. The only exception to the repeat requirements is: if the whole blood glucose test is a follow up of a previous high verified glucose test result.
19. For all results greater than 500 mg/dl (>500 mg/dl) a Glucose test by the Lab is required.  This is critical test. See policy # 6190-0005
20. For all results less than 20 mg/dl (<20 mg/dl) a Glucose test by the Lab is required. This is critical test. See policy # 6190-0005
21. Any time a result from the glucose meter is in question, verify with Lab Glucose should be done. Order a STAT Lab glucose test in Meditech.

SPECIAL CONSIDERATIONS, NOTES AND PRECAUTIONS:

1. For results outside the action range established at St. Peter’s Hospital proceed as follows:
   1. For results less than <20 mg/dl and for results >500 mg/dl, enter comment code "9" and press enter. Comment code 9" indicates confirmed with lab. Place glucose meter in docking station and call the laboratory.
   2. 2.       Results in the range of 20 –50 mg/dl must be repeated on the glucose meter (The only exception to the repeat requirements is: if the whole blood glucose test is a follow up of a previous low verified glucose test result.) The two results must agree within +/- 15 mg/dl. If results do not agree, then order a glucose test to be done by the laboratory.
   3. 3.       Results in the range of 300 –500 mg/dl must be repeated on the glucose meter (The only exception to the repeat requirements is: if the whole blood glucose test is a follow up of a previous high verified glucose test result.)  The two results must agree within +/- 35 mg/dl. If results do not agree, order a glucose test to be done by the laboratory.
2. If the blood glucose results appear to be inconsistent (lower or higher than expected), repeat test with a new test strip.
3. High or low results that are incorrect may have serious medical consequences. If the blood glucose result is unusual high (greater than 300 mg/dl or low (lower than 50 mg/dl, or the results are not consistent with physical symptoms, repeat the rest correctly with a new test strip. Verify that the finger used for testing is clean and dry. (Clean with soap and water then cleanse with alcohol before finger puncture.)  You may also use control solutions to check the performance of your system.
4. If a whole blood glucose test is repeated within five minutes of the first test, Meditech will disregard the first test and only record the second test result.
5. If the glucose result is lower or higher than expected, a glucose may be ordered from the lab to verify the results. Results that are incorrect may have serious medical consequences.
6. An agreement was made (see NOTE below) that repeats by lab of low glucose values for neonates was clinically unnecessary unless specifically requested by the physician because the treatment would remain the same despite the value of the recheck. Evaluation of low glucose values obtained from the Precision PXP and the values obtained in the laboratory revealed excellent correlation and no clinically significant difference.
7. NOTE: This agreement was made 3-20-2004 by the OB Director, Lab Director, and Point-of-Care-Testing Coordinator. This agreement applies to infant care only. Call the lab when a whole blood glucose test result is less than 50 mg/dl. Notify the lab if glucose verification is needed or not.
8. The suggested policy on whole blood glucose for an infant: Do bedside Whole Blood Glucose testing on SGA and LGA babies at 1 hour of age; and on any baby at risk and offer feeding. Notify physician if lab glucose less than 40mg/dl. Glucose results less than 50 mg/dl on the Precision PXP should be followed up with a STAT glucose done by the lab only if a low range quantitative result is required. A Precision PXP result less than 50 mg/dl should be interpreted as a glucose value less than 50 mg/dl and should be reported as <50mg/dl. Note: This protocol will decrease number of skin punctures and amount of blood collected from infants because a follow up glucose by the lab will not be done unless it is medically necessary to obtain a low range qualitative glucose result.

HELPFUL TIPS:

1. Dock the meter as soon as possible. The test is not complete until meter is placed in docking station
2. Notify the lab ext: 2319 when there is a glucose draw to be done.
3. Whole Blood Glucose action range: 50-300 mg/dl. For results outside action range do the following

Glucose meter Result	Action to take
Greater then 20 but less than 50 mg/dl 20-50 mg/dl	Repeat of the test on the glucose meter If results are within +/- 15 mg/dl accept the last result. If results are greater then +/- 15 mg/dl order a STAT glucose to be done by the lab.
Greater than 300 mg/dlbut less than 500mg/dl 300-500 mg/dl	Repeat of the test on the glucose meter If tests agree within +/- 35mg/dl accept the last result. If tests results varies more than 35 mg/dl order a STAT glucose to be done by the lab.
Greater than 500 mg/dl (>500 mg/dl)	Glucose test by the Lab must be performed.
Less than 20 mg/dl (<20 mg/dl)	Glucose test by the Lab must be performed
Any time a result from the glucose meter is in question	Verify with a Lab Glucose test.

SOURCE OF ERROR: LIMITATION OF PROCEDURE

1. System is not designed for use with serum or plasma. Use only whole blood samples.
2. Test results may be erroneously low if the patient is severely dehydrated or severely hypotensive, in shock, or in a hyperglycemic-hyperosmolar state (with or without ketosis.)
3. High level of the following substances at the following concentrations do not affect results: uric acid, 23.5 mg/dl; unconjugated bilirubin, 40 mg/dl; ascorbic acid 5 mg/dl; cholesterol 500 mg/dl; and triglycerides 1500 mg/dl, Maltose 110 mg/dl, Galactose 45 mg/dl,
4. The test strip has been evaluated with neonatal blood. As a matter of good clinical practice, caution is advised in the interpretation of neonate glucose values below 50 mg/dl.
5. Room temperature is < 59˚F ( 15˚C)  may result in lower then expected result
6. Water or alcohol remaining on the puncture site may result in lower then expected result
7. Finger used for puncture site was not washed with soap and water and therefore glucose molecules present on the finger might elevate the result.
8. Room temperature >104 ˚F ( 40˚C)  may result in higher then expected result.
9. Use between relative humidity of 10% and 90% for best results.
10. Clinical testing demonstrates that altitudes up to 7,200 feet above sea level do not  affect results, according to Precision Xceed Pro Glucose test strip insert.
11. The test strip has been evaluated with neonatal blood. As a matter of clinical practice, caution is advised in the interpretation of neonate glucose values below 50 mg/dl.
12. Do not use during intravenous infusion of high-dose ascorbic acid during xylose absorption testing

EXPECTED RESULTS: Expected Results for Non-Diabetic, Non-Pregnant Adults   

1. Fasting values: 70 to 110 mg/dl. 
2. One or two hours after meals: Less than 140 mg/dl

SAFETY PRECAUTIONS:

1. Never look into the scanner bean or point it toward anyone’s eyes. The beam could cause permanent damage to the eye.
2. Handle all specimens and control solutions as biohazards.

QUALITY CONTROL FREQUENCY:

1. Control tests should be done:
   1. Daily
   2. With a questionable glucose result 
   3. When opening a new lot of test strips.
   4. Control test may be performed at any time
2. Linearity Checks: The lab does linearity (calibration) checks.
   1. Linearity checks are done every 6 months and also before a new strip lot is put in use.
   2. Linearity check is done before a Precision PXP monitor is put in use.
   3. Linearity check must pass before glucose meter can be put in use.
   4. Calibration Reagent: RNA Glucose and β-Ketone Verification

GENERAL MAINTENANCE:

1. Cleaning the external surface of the Precision PCB Monitor is recommended daily. The monitor needs only to be cleaned with a water-moistened cloth and mild detergent. Any germicidal disposable cloth wipes can be used if needed. Ammonia and alcohol based cleaners should be used. Acceptable cleaning solutions include: Sani-Cloth HB, Sani-Cloth Plus, and Super Sani-Cloth. Do not use bleach.
2. Turn off the monitor while it is being cleaned.
3. Clean the scanner window with water or lens cleaner and wipe dry with gauze. NOTE: Finger prints or a smudge on the scanner window can cause scanning error.
4. The monitor requires two (2) AA alkaline batteries. Turn off the monitor before replacing the batteries.        

TROUBLE SHOOTING: 

EQUIPMENT PERFORMANCE EVALUATION:

1. Lab will perform monthly inspection of Precision PXP meters used in the hospital setting. Glucose meter used in Ambulance will also be inspected monthly.
2. Any time a problem is encountered with the glucose monitor, bring the faulty monitor to the lab and obtain a Precision PXP monitor from the lab.
3. The lab will review quality control performance on a regular basis.   .        

PATIENT TEACHING:

DOCUMENTATION:

1. Whole glucose tests result are recorded in Meditech; a printed result is printed in the department of the patients registration. This will take place when the meter is placed in a docking station. Result can be viewed in EMR with the exception of Home Health and Ambulance.
2. Whole blood glucose testing performed at Home Health and Ambulance and in Clinics will be manually recorded according to department procedure. Record the time and date of testing. Laboratory review data for control and patient data verification.

SPH SITES PERFORMING WHOLE BLOOD GLUCOSE TESTING

Dialysis, MED/ONC, ICU, OR, OB, SURG UNIT, SDS, ER, Pulmonary Rehabilitation, Home Link, AMB, SPMG, NMC, BMC, Clinical Nutrition, Infusion Center.

SKIN PUNCTURE PROCEDURE:

1. Gather the necessary equipment
2. Select a skin puncture site. Finger stick the puncture site must be on the palmar surface of the distal phalanx and not at the side or tip of the finger. The middle finger and ring finger are the fingers of choice. The thumb and little finger are not to be used. Capillary sites must be properly warmed prior to procedure. Using a warm, moist towel or infant heel-heating device, (not greater than 42°C) to the area for 3-5 min, prior to puncture.
3. Prepare the puncture site aseptically using soap, water, and an isopropyl alcohol wipe and dry with sterile gauze pad. Do not puncture the site until the alcohol is dry.
4. Use disposable one application lancet or disposable one application needle device.
5. Avoid any edematous site or within 2 mm of a previous puncture. For Heel stick, puncture the skin no greater than 2.4 mm. Wipe away the first drop of blood to eliminate tissue contamination using sterile gauze.
6. Holding the puncture site downward and gently applying pressure to the surrounding tissue proximal to the site when the blood is obtained from a finger, enhances blood flow. Strong pressure or milking is not used as it may cause hemolysis or contaminate the specimen with tissue fluid.
7. If more than one drop of blood is needed then between each drop collected, pressure on the puncture site should be relaxed to allow for capillary refill.
8. Dispose of biohazardous materials according to protocol.
9. After blood has been collected from an infant's heel, the foot should be elevated above the body and a sterile gauze pad pressed against the puncture site until bleeding stops. This facility uses sensitive skin "dots" on newborn. After blood is collected from finger or toe, insure the bleeding has stopped and cover with sterile bandage. Do not apply regular adhesive bandages over skin puncture sites on children less than two years old. (Older infants and toddlers may remove the bandage and put in its mouth and possible aspirate it)
10. Infant Heel Stick  DO NOT:
11. Do not puncture deeper than 2.4mm (may cause bone damage)
12. Do not use previous puncture site
13. Do not use posterior curvature of the heel
14. Do not use the central area of the foot.

REFERENCES:

1. MediSense PXP Point-Of-Care System manual ART14576 Rev. A 11/07
2. MediSense Precision PXP Test Strips ART11350 Rev.A 09/06 Abbott Laboratories
3. MediSense Precision PXP Test Strips ART12964 Rev B 07/08 Abbott Laboratories
4. MediSense, 4A Crosby Drive, Bedford, MA 0130-1402
5. Venipuncture (Custom Lippincott procedure)
6. Bloodborne Pathogen Control Plan (Lotus Notes, #150-0001)

Composed by Kerstin Raye Point-of-Care Coordinator, 

Originally approved by: Kathleen McCarthy (Director, Lab) and Tammy Buyok (VP, Support Services)

Composed:  5/14/03, 

Revised:  5/15/07, 9/8/07, 12/29/08, 4/8/09

Published: 4/6/05, 8/10/05, 11/06/05, 5/30/07, 9/9/07, 12/29/08, 4/08/09