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Procedure - BJC HealthCare in St. Louis 13 Hospitals and Multiple

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Quality Control must be stored at Room Temperatur0 degrees C. Failed Quality Control testing may be the result of one of the following:

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 1 of 10

     ? PROCEDURE: SURESTEPFLEX WHOLE BLOOD GLUCOSE MONITORING

ISSUE DATE: May 2001 REVISION DATE: February 2009

PRINCIPLE:

Capillary, venous, arterial and neonatal whole blood glucose levels will be determined and patient treated

    according to physicians orders. A small drop of blood is applied to a SureStepFlex Test Strip. A glucose

    oxidase reaction occurs between the glucose in the blood and reagents in the test strip resulting in the

    formation of a blue color. This 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 test strip is inserted into the

    SureStep Pro/Flex Bedside Unit, the unit measures the color intensity and reports a plasma-calibrated

    glucose result. All results (patient and control) are transferred via modem from each Bedside Unit to the

    LifeScan SureStep workstation located in the laboratory for review of Quality Control and critical results

    by the Point-of-Care Coordinator or designee.

Only appropriately trained personnel shall perform this procedure. These users will be required to

    demonstrate quality control competency twice a year, participate in proficiency testing periodically and

    certified annually, through an education quiz on line, CHEX.

CLINICAL SIGNIFICANCE:

Critically ill patients including those with diabetes, receiving hyoperalmintation therapy, or exhibiting diabetes-

    like symptoms brought on by certain drug treatments, typically requires more frequent monitoring of their

    blood glucose concentrations. Testing at the bedside is therefore an important aspect of immediate care.

EQUIPMENT:

? SureStep FLEX Bedside Unit

    ? SureStep FLEX Test strips

     3 AA batteries for SureStep FLEX

    ? SureStep High and Low Control Solutions ? Lancet

    ? Alcohol prep pads

    ? Disposable gloves

    ? Connection Module

    ? Germacidal 10% bleach wipe.

    ? SureStep Linearity Test Kit

Backup Method/ Replacement Unit

The backup instrument for the SureStep FLEX Bedside Unit is another SureStep FLEX Bedside Unit available from the Core Laboratory (x44268). Send Glucose specimens to the Core Laboratory until another SureStep Location of online document: C:\convert\temp\55537071.doc FLEX is available and quality control is performed.

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 2 of 10

SPECIMENS:

Patient Preparation: Capillary blood can be obtained from puncturing the fingertip or heel using a lancing

    device. The puncture site should be cleaned with alcohol and thoroughly dried before

    obtaining the blood sample, wipe away the first drop to prevent contamination.

    Follow nursing/laboratory guidelines for specimen collection.

Type: Fresh whole blood capillary, venous, arterial, or neonatal blood may be used.

    Anticoagulants such as heparin and EDTA may be used. Do not use preservatives

    that contain fluoride (gray top tubes).

Handling Analyze the blood sample as close as possible after collection. Testing of venous and

    arterial samples should be performed within 30 minutes of sample collection to

    minimize glycolysis. If using fresh whole blood (capillary) in the absence of an

    anticoagulant, test immediately to prevent clotting from affecting the results.

REAGENTS:

Storage and Handling

1. Date the SureStep FLEX Test Strips vial when first opened. Do not use the SureStep FLEX Test Strips

    after four months from the “opened vial date” or after the expiration date printed on the strip vial,

    whichever comes first.

2. Date the SureStep FLEX Control Solution vials when bottles are first opened. Do not use the SureStep

    FLEX Control solutions after 90days from the open vial date or after the expiration date printed on bottles,

    whichever comes first.

3. Always keep the SureStep FLEX Test Strip vial tightly capped.

    4. Store reagent strips and control solutions at room temperature (less than 30?C) away from heat and

    humidity.

5. Unused strips should always be stored in the original container and remove the strip only immediately

    before using. Do not return any used strips to the vial.

QUALITY CONTROL:

Low and High Glucose Control Solutions must be run each 24 hours of use. Control solutions must also

    be run:

    ? If a patient test has been repeated and the blood glucose results are still lower or higher than expected.

     ? When troubleshooting the system. Location of online document: C:\convert\temp\55537071.doc ? If you drop the bedside unit.

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 3 of 10

    Results that fall within the expected assigned range, when testing in the bedside unit’s QC Test mode are

    indicated by PASSED on the bedside unit display. Results that are not within the expected assigned range

    are indicated by FAILED. Patient testing cannot be performed when quality control fails. Operator will be

    locked out of patient testing.

    Quality Control must be stored at Room Temperature <30 degrees C.

    Failed Quality Control testing may be the result of one of the following:

? Procedural error

    ? Old or contaminated glucose control solution

    ? Incorrect test strip lot number entered in the bedside unit

    ? Debris in the lens area and test strip holder

    ? Test strip deterioration

    ? Unit malfunction

    ? Control solution outside the 15?-35?C functional temperature range.

Quality Control Testing

1. Turn on the bedside unit using the blue power button.

    2. Check the battery status to ensure adequate power. Press “Cont.”.

3. Select “QC Test” from the Main Menu. If quality control testing has not been performed within the last 24

    hours, a screen will automatically appear that displays “QC Due: QC Missed or Failed”. If this screen

    appears, QC testing must be performed before patient testing. Touch the “QC Test” area on the screen,

    and perform the required QC testing.

4. Enter your operator ID by manually entering your employee identification number or scanning the bar

    code on your employee badge. If you have not performed QC within the last 6 months (competency), a

    screen will automatically appear that displays “QC Due: QC Missed or Failed”. If this screen appears,

    QC testing must be performed before patient testing. Touch the “QC Test” area on the screen and

    perform the required QC testing.

5. Select the control level you wish to run, or if in QC lockout, the meter will prompt you to run the HIGH QC

    first.

6. Select the test strip lot number from display.

7. Gently shake the control solution vial. Apply one drop of control solution to the pink test square on test

    strip. Check the confirmation dot on the back of the test strip to ensure adequate application.

8. Insert the test strip into the test strip holder within 2 minutes of applying control solution. Advance the strip

    until it comes to a complete stop.

9. The result appears on the bedside unit LCD in approximately 30 seconds with the acceptable range noted

    Location of online document: C:\convert\temp\55537071.doc

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 4 of 10

    below the value. If the result is acceptable, “PASSED” will also be displayed. Press “OK”. Or you may

    enter a comment by pressing “Enter Notes”. Select an appropriate comment from the comment list and

    press “OK”.

10. If test results fall outside the expected range, “FAILED” will be displayed with the results and guiding

    messages will appear:

     a. Repeat test

     b. Shake ctrl

     c. Expired strip?

     d. Expired ctrl?

     e. Clean meter

11. Push enter notes, select up to three of the most appropriate corrective action comment(s):

    a. Procedure err

    b. Shook control

    c. New strip vial

    d. Used new QC

    e. Repeated test

    f. Cleaned meter

12. Remove the strip and dispose of using universal precautions.

13. Do not proceed with patient testing until acceptable QC results are obtained, operator will be locked out.

Note: Quality Control Testing must be performed and acceptable each 24 hours of use.

Calibration Verification

1. All new meters, upon receipt will have the calibration verification performed. Five vials of glucose solution

    in duplicate at varying concentrations. Value assignment is test strip lot number dependent. After data is

    transmitted to Data Link Software in the POCT area, a report that consists of a linearity plot are printed. The

    POC technologist reviews the report for acceptability of the slope (0.90 to 1.10).

2. Every six months the calibration is verified by analyzing 3 vials of glucose solutions in duplicate of varying

    concentrations on a representative number of meters. All meters are rotated. Data is transmitted to Data

    Link software in the POC area. The report is reviewed by the POC technologist for acceptability of the slope

    (0.90 to 1.10), and signed by the laboratory medical director..

3. New strip lots are also checked. See Point of Care procedure for evalutating a new strip lot.

PROCEDURE:

Patient Testing

1. Verify patient identification and orders.

    Location of online document: C:\convert\temp\55537071.doc

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 5 of 10

2. Explain procedure to patient.

3. Turn on the bedside unit

4. 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.

5. Select “Patient Test” from the Main Menu.

6. Enter your operator ID by entering employee number manually or scanning bar code on employee badge.

7. Enter the patients ID by entering the 7 digit medical record number manually.

8. Select the test strip lot number from the display.

9. Obtain sample:

    Capillary blood specimen:

     a. If performing a heel stick, warm the heel with a heel warmer.

    b. Wipe the finger or heel with alcohol to reduce surface pathogens and allow to air-dry completely.

     c. Perform finger or heal stick, according to nursing/laboratory guidelines.

    d. Gently squeeze the fingertip/heal to obtain a drop of blood. Wipe away the first drop.

10. 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.

11. Insert the test strip into the test strip holder within 2 minutes. Advance the strip until it comes to a

    complete stop.

12. The result appears on the bedside unit LCD in approximately 30 seconds.

13. Record patient result appropriately.

14. If HIGH is displayed or if the patient’s blood glucose level is above 450 mg/dL, repeat the test. If HIGH

    appears again, report result as “>450 mg/dL” and notify physician.

15. Critical values will be tagged with guiding messages: See critical values range on page 7 of this

    procedure.

    a. Repeat test

    b. Notify Dr.

    c. Notify RN

    d. Verify orders

    14. Select “ENTER NOTES”. Patient comments are as follow:

    a. Procedure err

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     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 6 of 10

    b. Notify Dr.

    c. Notify RN

    d. Follow orders

    e. Neonate

    15. Select up to three appropriate comments and push “OK”.

16. Results <20 will be reported as <20 and results >450 will be reported as >450.

17. Remove the strip and dispose of all testing materials using universal precautions.

18. Press the blue power button to turn off the meter when testing is complete. The meter will automatically

    shut off after 5 minutes of inactivity.

19. If the patient is experiencing symptoms which are not consistent with the blood glucose results obtained

    from the meter and you have followed the test procedure as described in the procedure, follow the

    policies for treating the symptoms and confirm the blood glucose results with a laboratory test is

    requested by the patients physician.

Patient Contact Precautions:

1. Assemble all necessary testing supplies needed to perform a single test just outside the patient’s room.

2. Gown/dress appropriately.

3. Set-up meter: for example, enter operator ID, patient ID, strip lot number etc. Note: at this point you have

    5 minutes until the meter turns off.

4. Enter room with fingerstick supplies and one test strip.

5. After dosing test strip, discard fingersticking supplies appropriately. Remove one glove and reach out of

    the room to insert strip into the meter.

    6. Degown, remove remaining glove, wash hands, and exit room.

Data Management Procedure:

The connection module, used with a modem, provides a remote communication link between the bedside

    units and the laboratory workstation. By placing the bedside unit in the connection module and selecting

    “Transfer data”, the data is automatically transferred to the workstation where it is reviewed by the Point-of-

    Care coordinator.

NOTE: THIS PROCEDURE IS TO BE COMPLETED WEEKLY BY THE NURSING UNIT (S).

1. Select “Transfer Data” from the Main Menu.

    For the SureStep FLEX meters will automatically download when placed in the modem.

    2. Place the bedside unit in the connection module.

    Location of online document: C:\convert\temp\55537071.doc

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 7 of 10

3. The modem will begin to dial. If the line is busy, the connection module will retry up to 20 times at 30-

    second intervals before it times-out.

4. A message will appear on the screen indicating the status of the connection. The indicator light on the

    connection module blinks as data is transferred. A message appears when data transfer is complete.

    5. Remove the bedside unit from the connection module and press “Cont.” to continue with patient testing,

    or turn the unit off, using the blue on/off button.

6. Remove the bedside unit from the connection module and press “Cont.” to continue with patient testing,

    or turn the unit off, using the blue on/off button.

SureStep FLEX Cleaning / Maintenance

Meters will be cleaned whenever visible blood is present on the bedside unit, and at least weekly.

1. Press down on the left side of the test strip holder to release it from the bedside unit.

2. Wipe the test strip holder cover and base with a cotton swab or soft cloth dampened with a 10% bleach

    wipe. Follow with water to remove any residual bleach.

3. Dry the test strip holder with a soft cloth or lint-free tissue.

4. Wipe the lens area and contact points with a 10% bleach wipe. Use a swab or tissue moistened with

    water to remove any residual bleach.

3. Dry the lens area gently with a clean, soft, lint-free tissue. Remove any lint.

4. Slide the closed test strip holder into the unit and push until it clicks into place. If necessary, wipe the

    scanner with a soft tissue dampened with water.

5. The Sure Step/Flex must be cleaned with 10% Bleach when taken in an Isolation Precaution patient’s

    room.

RESULTS:

Normal Values

    0 days - 1 month 40 - 100 mg/dL

    Greater than 1 Month 65 - 199 mg/dL

Critical Values (Check patient chart for special orders regarding alert values)

    Greater 1 Month <65 mg/dL ?350 mg/dL

    0 1 Month <40 mg/dL ?300 mg/dL

Measurement Range of SureStep FLEX

    Location of online document: C:\convert\temp\55537071.doc

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 8 of 10

    0 - 500 mg/dL

    If the blood glucose is greater than 500 mg/dL, the meter will display HIGH.

    Reportable Range

    20 mg/dL - 450 mg/dL

    LIMITATIONS OF THE PROCEDURE:

    1. Use only fresh whole blood. Do not use serum or plasma.

    2. Use an adequate amount of blood: just enough to cover the pink test square. DO NOT overdose the strip.

    Over-dosing may cause false high results. If the entire white pad is saturated with blood, you have

    applied too much. Repeat the application with a new test strip applying a smaller drop of blood. DO NOT

    under-dose. Under dosing may cause false low results. If the confirmation dot on the back of the test

    strip is not completely blue but shows patches of white, you have not applied enough blood. Repeat the

    application with a new test strip and apply a larger drop of blood.

    3. Extremes in hematocrit can affect test results. High hematocrits (above 60%) and low (below 25%) on

    non-neonatal samples can cause false results.

    4. Blood glucose results obtained with SureStepPro Test Strips may be affected if excessive water loss or

    dehydration occurs.

     Severe dehydration can lead to many serious medical complications. One

    complication, which is of particular importance in diabetes management, is a hyperglycemic-hyperosmolar

    state, with or without ketosis, which may be life threatening if left untreated.

5. Do not use blood collection tubes containing fluoride. Sodium fluoride interferes with test results.

6. Highly lipemic (fatty) blood samples, up to 3000 mg/dL triglycerides, have no significant effect on results.

7. Ascorbic acid, at concentrations of 3 mg/dL, has no significant effect on the results.

8. 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 (venous values are lower than capillary values after food

    intake).

9. If Quality Control and patient testing procedures are not followed, results may not be accurate

NOTE: Additional Precautions for Neonatal Testing:

10. All neonatal values, not consistent with clinical findings should be confirmed by a clinical laboratory test

    method. All neonates exhibiting hypoglycemic symptoms, regardless of blood glucose monitoring results

    should have their glucose tested by a clinical laboratory test method.

     11. Use caution when interpreting neonatal blood glucose results, which are less than 50 mg/dL. Location of online document: C:\convert\temp\55537071.doc

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 9 of 10

Transport Team

    1. Transport Team uses the Sure Step Blood Glucose Monitoring system meters in the Transport bags.

    2. Procedure Book in each bag and also in the Transport Team Point of Care Manual.

    3. Sure Step uses the same LifeScan strips and Quality Control lots as the FLEX meters.

DOCUMENTATION:

1. Record the results in CareManager, the electronic patient flow sheet..

2. Notify physician for all alert values unless otherwise noted. Alert values are blood sugars <40 or ?350

    mg/dL. Document physician called, time, date, and callers initial by result.

3. For all results that fall outside the verified linear range, (20 mg/dL - 450 mg/dL), repeat test, notify the

    attending physician and report as ?20 mg/dL or ?450 mg/dL. Obtain a stat blood glucose test from the

    laboratory, if the physician requests.

4. All patient and quality control results will be transferred from bedside units to the laboratory workstation

    via the connection module..

LINEARITY:

The laboratory Point-of-Care department will do linearity testing. Procedure available in the Point-Of-

    Care procedure manual.

REFERENCES:

1. SureStep Bedside Unit Operators Guide, Lifescan, Inc., 1997.

2. SureStep Glucose Testing Procedure, Lifescan, Inc., 1997.

    Location of online document: C:\convert\temp\55537071.doc

     Department of Laboratories

    St. Louis, MO 63110

    POC.1.0009.0 version 1.4

    Page 10 of 10

Donna Walck Point of Care Coordinator)

    Written By:

________________________________________________ _______________________

    Technical Supervisor Date

________________________________________________ _______________________

    Medical Director Date

Annual Review: Medical Director/Designee Date

________________________________________________ _______________________

________________________________________________ _______________________

________________________________________________ _______________________

________________________________________________ _______________________

________________________________________________ _______________________

________________________________________________ _______________________

________________________________________________ _______________________

________________________________________________ _______________________

    Location of hard copy location(s): Core Lab Office

     See Test Methods / Test Locations (POC.1.0002.0)

     ________________________________

     ________________________________

    Date Archived: _______________________

    Location of online document: C:\convert\temp\55537071.doc

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