Point-of-Care Testing

<Very Good Health Hospital>

PRINCIPLE:

Point of Care Testing (POCT) refers to those analytical patient testing activities provided within the hospital, but performed outside the laboratory. Activities of the POCT program must comply with all current standards for laboratory accreditation, regardless of the scope of testing. Designated laboratory personnel have centralized the coordination of the POCT program.

The Boehringer Mannheim Corporation (BMC) Accudata Glucose Testing Station (GTS) using the Accu-check Advantage monitor is used for blood glucose determinations at the bedside. This system uses a drop of whole blood placed on a reagent strip and inserted into a monitor to obtain the glucose value. The monitor’s test reaction is based on the enzyme glucose dehydrogenase converting the glucose in the blood sample to gluconolactone. This reaction liberates an electron that reacts with a coenzyme electron acceptor, the oxidized form of the mediator hexacyanoferrate (III), forming the reduced form of the mediator, hexocyanoferrate (II). The Advantage test strip employs the electrochemical principle of biamperometry. The monitor applies a voltage between two identical electrodes, which causes the reduced mediator formed during the incubation period to be reconverted to an oxidized mediator. This generates a small current that is read by the monitor.

Operation of the Accu-Chek Advantage monitor can be performed by the following trained individuals: Registered Nurse (RN), Graduate Nurse (GN), Licensed Practical Nurse (LPN), Clinical Technical Associate (CTA), Patient Support Associate (PSA), and a Clinical Technician (CT). These individuals can only perform a blood glucose that has been initiated with a physician’s order. These individuals must be trained by a BMC representative or a <Very Good Health Hospital> trainer initially and must show competency at least once per year.

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SPECIMEN COLLECTION AND HANDLING:

Personal Protective Equipment (PPE) such as gloves, gown and/or goggles must be worn when handling patient blood samples and quality control samples. Please refer to the Hospital Administrative Policy xxx- OSHA Standard Compliance for more specific information.

I.  Specimen:

Samples obtained for use on the Accu-Chek Advantage monitor must be capillary specimens unless otherwise stated by the laboratory. A minimum sample size of 9uL and a maximum sample size of 50 uL is required.

II. Special Considerations:

*If possible the patient should wash his or her hands prior to drawing a capillary sample from the fingertip. If this is not possible, make sure the finger is cleaned with an alcohol swab before performing the fingerstick.

*The capillary sample must be tested immediately after collection.

REAGENTS AND EQUIPMENT:

1. Accudata GTS with Accu-Chek Advantage Monitor
2. Advantage comfort curve test strips (Cat. No. 2030365)
3. Advantage controls (Cat. No. 2030390)
4. Safe-T-Pro disposable lancing devices (Cat. No. 951) or pediatric lancing devices.
5. Alcohol swab
6. Cotton ball, tissue, or gauze for wiping finger after stick
7. Disposable latex gloves

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STORAGE AND STABILITY:

Advantage monitor:

The monitor should be stored between 14^oC and 40^oC (57^oF to 104^oF) away from moisture.

Advantage test strips:

The Advantage test strips must be stored between 14^oC and 40^oC (57^oF to 104^oF). They must be stored in the same tightly capped vial in which they are packaged. The vial cap must immediately be replaced after the removal of a test strip. The test strips are stable until the expiration date printed on the vial. The date the test strips are received and opened must be written on the vial label. Test strips should be kept at less than 85 % humidity for the most accurate results.

Advantage low and high controls:

The Advantage low and high control solution vials must be stored at room temperature. The control solutions are stable until the expiration date printed on the vial or 3 months after opening, whichever comes first. The date the control solutions are received and opened must be written on the vial label along with the new expiration date if applicable.

CLEANING AND MAINTENANCE:

1. Cleaning of the Accu-chek GTS and the Advantage monitor is recommended whenever blood or body fluids have spilled on the monitor. Either a 10% fresh bleach solution or 70% isopropyl alcohol can be used to gently wipe the areas that are contaminated. Operators should keep moisture away from the test strip guide and only use a soft cloth on the monitor display areas. Comment code 03 (which translates to "Clean Monitor") must be used to document cleaning of the monitor. This information will be reviewed by the Medical Director on a monthly basis to track problems and/or concerns with cleaning the monitor.
2. Six size C batteries for the Accu-chek GTS can be obtained from the storeroom. The monitor will display "change batteries" when necessary. The Advantage monitor requires 2-3 volt batteries obtained from the storeroom. The Advantage monitor will display a small battery icon when necessary. The comment code 06 (which translates to "Change batteries") must be used to document that batteries were changed. This information will be reviewed by the Medical Director on a monthly basis to track problems and/or concerns with changing batteries.

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CALIBRATION:

The Accu-chek Advantage monitor must be calibrated each time a new lot number of Advantage test strips is opened. Otherwise, calibration should be performed at least every six months or more often if deemed necessary.

Each box of test strips has a code key that contains the information needed to calibrate the instrument. This code key is to be left in the GTS unit until calibration is performed in six months or the monitor has prompted an operator to calibrate.

Calibration verification using the linearity test kit (Cat. No. 987) must be performed when reagent lots are changed, when indicated by quality control data, after major maintenance or at least every six months. The reportable range of 60-400 mg/dL for adults and 40-400 mg/dL for infants must be verified from the linear testing procedure and approved by the Medical Director.

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QUALITY CONTROL:

Quality Control vials (one low and one high solution) must be run on each Advantage monitor every 24 hours that the monitor is in use. The Accudata GTS has a 24 hour lock-out feature that requires both controls to be run producing values that fall within the acceptable control range before any other tests can be performed on the monitor. If the quality control values are within the acceptable range printed on the test strip vial, the user can proceed to patient testing. If the quality control values are out of the acceptable range printed on the test strip vial, the user must do the following:

1. Check the expiration date to verify that the control vial is stable. If it has expired, dispose of the control vial in the proper hazardous waste receptacle and obtain a new vial. Enter the 2 digit corrective action comment code into the GTS and run the new vial of control. See the procedural notes with detailed information on the proper use of comment codes.
2. If the control is still out of acceptable range, enter the proper 2 digit corrective action code again. Mix the control by gently inverting the vial 4 to 6 times and repeat.
3. If the control is still out of acceptable range, refer to the troubleshooting section of the User’s Manual or call the BMC Medical Service Center at 1-800-440-3638.

The quality control values are stored in the monitor until the information is downloaded weekly by the POCT Coordinator. The data obtained through this process will include: test result, operator ID, control level, control lot information, test strip code information, test time and date, and comment codes.

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PROCEDURE:

Calibration:

1. Remove the code key from the Advantage test strip box.
2. Compare the 3-digit number on the code key with the number on the test strip vial.
3. Make sure the Accudata GTS is turned OFF.
4. Remove the old code key form the Accu-chek Advantage module and snap the new code key (slots facing towards the monitor) into the code key slot.
5. Leave the code key in the Accudata GTS base and turn the monitor on by pressing the blue power on button.
6. Verify that the code number on the monitor display corresponds to the code number on the vial of test strips used.
7. If one cannot verify that the code number on the monitor and the code number on the test strip vial correspond, the monitor must be recoded (recalibrated).
8. Recalibrate the Accudata GTS by opening a new vial of test strips and placing the code key into the monitor once it has been turned off.
9. If recalibrating is unsuccessful do not use the monitor and call the Medical Service Center at 1-800-440-3638.

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Calibration Verification using Linearity Kit:

1. Press the blue power ON button located on the Accudata GTS base.
2. Once the date, time and code number (test strip lot number) are displayed on the LCD panel located above the number key pad, the instrument is ready to begin.
3. Select the MENU choice on the right by pressing that button.
4. Select QUALITY CONTROL by pressing the arrow button located below this selection.
5. Select LINEAR next and verify that the test strip vial corresponds to the code number on the GTS.
6. Select YES if the code corresponds and proceed. If the code does not correspond, follow the calibration procedure above.
7. Enter operator id. and press ENTER.
8. Verify the linear lot displayed on the GTS. Select yes if the lot number is the number you wish to use. Select NO and enter the correct lot number if the lot number displayed is not the lot number you wish to use.
9. Enter 5 or 6 for the number of solutions to be used from the linearity kit.
10. Perform the linearity testing by following steps 9-15 below in the Quality Control procedure.
11. Select YES to perform another linearity test until all levels are complete. Select NO when linearity testing is complete and the GTS will turn off.

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1. Press the blue power ON button located on the Accudata GTS base.
2. Once the date, time and code number (test strip lot number) are displayed on the LCD panel located above the number key pad, the instrument is ready to begin.
3. If controls have already been run, the monitor will display the CTRLS, REVIEW, and PAT options. If the controls have not been run, the monitor will display RUN CONTROLS with the CTRLS and REVIEW options.
4. Select the CTRLS choice on the left by pressing the arrow button located below this selection.
5. The instrument will ask you to verify that the code number on the test strip vial corresponds to the code number on the GTS display. Select YES by pressing the arrow button located below this selection, if these two numbers correspond. Select NO by pressing the arrow button located below this selection, if the code number displayed does not correspond to the code number on the vial of strips you have chosen to use. See the Procedure for entering test strip codes located in the Reagents section of the User’s Manual.
6. Enter the operator ID by pressing the correct sequence of number keys, then press enter.
7. Select the desired level of control by pushing the LEVEL1 button or the LEVEL2 button.
8. Verify that the lot number of control solution on the vial corresponds with lot number displayed on the GTS and select YES by pressing the arrow button located below this selection, if this number is correct. Select NO by pressing the arrow button located below this selection, if the lot number does not correspond. See the procedure for entering correct control lot numbers located in the Quality Control section of the User’s Manual.
9. Remove a test strip from the vial and immediately replace the cap.
10. When the flashing strip icon appears on the monitor display, gently insert the test strip (silver bar end) into the bottom end of the monitor. The yellow target area must be facing up.
11. When the flashing drop icon appears on the monitor display, apply one drop of control solution to the center of the yellow target area. Note: Do not allow the tip of the control solution to touch the test strip.
12. Once the control solution has been added to the test strip, a small box will flash on the monitor display and in 40 seconds the blood glucose value will appear.
13. Enter a comment code if necessary, then press ENTER. Comment codes provide evidence of corrective action when control results exceed defined tolerance limits. See procedural notes for a complete list of comment codes.
14. Remove the test strip from the monitor and dispose of the strip and the lancet in the proper biohazard receptacle.
15. Select YES on the GTS display to perform the other control test level. Verify the operator ID number and go to step 6 of this procedure. If no other control tests need to be performed, select NO on the GTS display and the instrument will automatically turn off.
16. The control results are stored in the GTS until the information is downloaded weekly by the POCT Coordinator. This information can also be retrieved by using the review function on the Acudata GTS.

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1. Press the blue power ON button located on the Accudata GTS base.
2. Once the date, time and code number (test strip lot number) are displayed on the LCD panel located above the number key pad, the instrument is ready to begin.
3. Select the PAT choice on the right by pressing the arrow button located below this selection.
4. The instrument will ask you to verify that the code number on the test strip vial corresponds to the code number on the GTS display. Select YES by pressing the arrow button located below this selection, if these two numbers correspond. Select NO by pressing the arrow button located below this selection, if the code number displayed does not correspond to the code number on the vial of strips you have chosen to use. See the procedure for entering test strip codes located in the Reagents section of the User’s Manual.
5. Enter the operator ID by pressing the correct sequence of number keys, then press enter.
6. Enter the patient ID (9 digit medical record number) by pressing the correct sequence of number keys, then press enter. If the wrong patient ID number is entered, comment code number 08 shall be added to this result.
7. Remove a test strip from the vial and immediately replace the cap.
8. When the flashing strip icon appears on the monitor display, gently insert the test strip (silver bars end) into the bottom end of the monitor. The yellow target area must be facing up.
9. When the flashing drop icon appears on the monitor display, obtain a blood sample with the Safe-T-Pro lancing device or pediatric lancing device. See the Laboratory fingerstick/heelstick policy as well as Infection Control Practice #12 for Phlebotomy Procedures for more details. Briefly touch the drop of blood to the center of the yellow target area. Completely cover the yellow target area with blood. Do not smear the blood on the yellow target area.

NOTE: The monitor may be removed from the GTS to make it easier to insert the test strip or to dose the test strip. The Advantage monitor should not be removed from the GTS before the flashing strip icon appears. Once the testing is completed, the monitor must be placed back on the GTS before the next test is performed.

10. Once the blood has been added to the test strip, a small box will flash on the monitor display and in 40 seconds the blood glucose value will appear. The value on the monitor display should correspond with the value on the GTS display. Verify this result on both displays.
11. Enter a comment code if necessary, then press ENTER. Comment codes provide evidence of corrective action when patient results are questioned and/or need to be repeated. See procedural notes for a complete list of comment codes.
12. Remove the test strip from the monitor and dispose of the strip and the lancet in the proper biohazard receptacle.
13. Select YES on the GTS display to perform another test. Verify the operator ID number and go to step 6 of this procedure. Select NO on the GTS display to turn the instrument off.
14. Once a patient result is displayed on the monitor, it must be recorded on the Daily Clinical Flow Sheet. The following information can be obtained from each patient by using the review function on the Accudata GTS: test result, operator ID, patient ID, test strip code information, test time and date, and comment code.

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PROCEDURAL NOTES:

*The comment codes available to the users after each patient test and each control run include:

0. No action needed
1. Repeat test
2. Wrong control run
3. Clean monitor
4. Replace test strips
5. Replace control solution
6. Change batteries
7. Operator error
8. Wrong patient ID
9. Wrong operator ID
10. Monitor taken out of service

20. Patient fasting
21. Patient not fasting
22. Physician notified, lab blood glucose drawn

A comment code must be entered or the test will automatically default to 00 (No action needed). Comment codes provide corrective action information.

*Contact Isolation Patients: If a patient with contact isolation requires blood glucose monitoring at the bedside, an Accudata GTS with Accu-Chek Advantage monitor should be designated for this patient and kept in the isolation room. Extra monitors will be available in the laboratory at both sites for use on these patients. These monitors must not leave the room of the isolation patient until the patient’s discharge. Proper cleaning and disinfecting the monitor by unit personnel is required before sending it back to the laboratory. See Contact Isolation Patients Protocol for detailed information.

EXPECTED PATIENT RESULTS:

The results of patient testing will be directly recorded on the Daily Clinical Patient Flow Sheet. The precision of the monitor is expected to be + 10%. If this precision after a repeat is not seen on the monitor and the operator believes this could be an unusual or unexpected result, the physician must be notified to determine if he wants a lab drawn blood glucose performed.

The Accudata GTS with Accu-Chek Advantage Monitor measures blood glucose levels from 10 to 600 mg/dL. A reading of LO on the monitor indicates a result below 10mg/dL and a reading of HI on the monitor indicates a result above 600 mg/dL. The normal fasting adult blood glucose range for a non-diabetic is 70-105 mg/dL.

Any result < 60mg/dL or > 400 mg/dL must be repeated. If the result is still <60mg/dL then:

The Hypoclycemia Protocol must be followed at <Hospital 1>, <Hospital 2>, and <Hospital 3> Hospitals. If the result is still >400mg/dL the result must be reported to the physician and a laboratory blood glucose must be drawn.

For infants located in the NICU and Newborn Nursery, a result of <40mg/dL must be reported to the physician and glucose feeds according to the Standard of Care Protocol must be initiated. The specific comment code for doing this must be entered into the monitor when indicated to document that the proper protocol was followed.

Before new lots of reagents are ready for use by operators, parallel studies must be performed. These studies must compare the previous lot number to the new lot number so that similar quality control and patient reference ranges are used throughout <Very Good Heath Hospital>. Data from at least 10 different floors to include at least 100 results must be collected by the POCT Coordinator to perform this comparison study. If the new lot of reagents does not correlate well according to the Medical Director’s analysis, the monitors must be re-calibrated and the comparison study should be performed again. If the new lot still does not correlate well, a new lot of reagents should be obtained from the Boehringer-Mannheim Corporation.

LIMITATIONS AND INTERFERING SUBSTANCES:

1. Use only Advantage test strips (Cat. no. 787) for testing capillary blood on the Accu-chek Advantage Blood Glucose monitor.
2. Patient’s hematocrit levels must be between 20 and 65% for this monitor to provide an accurate result. Blood glucose levels above 200mg/dL require hematocrits to be 25 to 55% to provide an accurate result. If hematocrits do not fall within these ranges, a lab blood glucose must be drawn in place of the bedside glucose.
3. If any yellow mesh is still visible on the test strip after the drop of blood has been applied, more blood may be applied within 15 seconds of the first dose. If more than 15 seconds have passed, the test result may be erroneous and the test must be repeated.
4. Galactose in excess of 10 mg/dL may give falsely elevated results versus a whole blood reference. No interferences were found with other reducing sugars.
5. Uric acid concentrations greater than 10mg/dL in hypoglycemic patients (blood sugars <70 mg/dL), and uric acid > 16 mg/dL in euglycemic and hyperglycemic patients (blood sugars >70 mg/dL) may give falsely elevated results versus a whole blood reference.
6. In situations of decreased blood flow, fingerstick blood testing may not be appropriate because it may not reflect the patient’s true physiological state. Examples would include but are not limited to: severe dehydration caused by diabetic ketoacidosis or the hyperglycemic hyperosmolar nonketotic state, hypotention, shock, or peripheral vascular disease.

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REFERENCES:

Accudata GTS User’s Manual, Boehringer Mannheim Corporation. 1995.

Total Quality Management Policy Manual, Boehringer Mannheim Corporation. 1997.

NCCLS GP2-A3 Guidelines for Clinical Laboratory Technical Procedure Manuals

Fundamentals of Clinical Chemistry, third edition, Teitz, 1987