36C26219R0026-028.pdf

VISN 22 Consolidated Pathology & Laboratory Medicine Service

VA Loma Linda Healthcare System Loma Linda, CA 92357

Issue Date:

01/15/2019

Approved by:

Heather Rojas (Physician)

Version

Document Owner:

Marilyn Malto (ATC)

POC-S8531 WHOLE BLOOD GLUCOSE USING ACCU-CHEK® INFORM II

Printed copies are for reference only; Please refer to the electronic copy for the latest version

Purpose:

The Accu-Chek Inform Glucose Meter is intended to measure whole blood glucose at the patient’s bedside (Point of Care).

Principle:

The enzyme on the strip, mutant variant of quinoprotein glucose dehydrogenase, converts the glucose in the blood sample to glucunolactone. This reaction creates a harmless DC electrical current that the meter interprets for the blood glucose result.

Policies:

A. Blood glucose tests with the Accu-Chek Inform II System must be ordered by a physician unless the patient is experiencing symptoms of hypoglycemia or hyperglycemia and quality of care dictates a STAT test.

B. All results from repeat testing within 15 minutes that have >10% difference should be confirmed with glucose lab test.

C. All critical results should be repeated immediately before reporting to physician and documented in CPRS using the hypo/hyperglycemia template.

D. Instruments should only be used by trained and certified operators.

Operators must be trained upon hiring then annually thereafter and as needed for the purpose as remedial to re-activate access.

E. Accuchek Inform II meters CAN NOT be used to test finger stick glucose on Critically ill patients defined by the critical care team of the facility.

Critically ill patient is

Ø “A patient requiring mechanical ventilation with a mean arterial pressure less than 60 mmHg despite the use of vasopressor agent”.

Ø A patient must have the three above identifiers.

F. It is the end user’s responsibility to assess and identify their patient as

“Critically ill”.

G. Glucometers must be cleaned and decontaminated before testing controls and after testing each patient.

H. Glucometer accuracy and operator competency will be performed every 4 months using proficiency testing materials acquired from College of American Pathologists (CAP) or other approved proficiency testing source.

I. A personal access code will be assigned to users and should never be shared.

J. Use an auto-disabling single-use lancing device for each patient

Version: 7

K. Printouts of all reports can be acquired as needed. Notify Ancillary Testing Coordinator if reports are needed.

L. Patient records are retained for minimum of two years.

M. All Quality Control Records are retained in the system for a minimum of two years.

Responsibilities:

1. Testing personnel from hospital wards and clinics:

• Nurse Practitioners,

• Registered Nurses

• License Vocational Nurses and

• Health Technicians

• Nursing Assistant NOTE: In order for the RALS/ALERE to recognize Glucose Testing operator, Nursing assistant that are trained to use the Accuchek must log into their CPRS and VISTA account once in every 2 months.

Note: In addition to testing, the testing personnel are responsible for maintaining the cleanliness of the meter. Refer to “Maintenance” section in this document for instructions on how to clean AccuChek Inform meters between each patient’s testing.

2. Test Site Manager:

• Maintain competency list of operators in their representative areas

• Conduct training and competency of operators within scope of service

• Conduct testing of proficiency testing sample

• Collaborate with the Ancillary Testing Coordinator to;

Ø Submit completed original copies of training documents Ø Asses and follow up on error/variance reports Ø Submit error/variance documentation follow up to Ancillary Testing

Coordinator.

3. Ancillary Testing Coordinator, or designee from Pathology and Laboratory

Medical Service, is responsible for:

• Initial set up of the instruments

• Accuchek Inform II strip inventory

• Strip and Control lot number editing

• Validation of strips and controls before use

• Daily Quality Control Review

• Monthly review of Levy-Jennings

• Training and competency of test site manager and testing personnel

Materials:

Supplies & Reagents

1. Accu-Chek Inform II Strips

a. Store test strips at room temperature. Do not refrigerate or freeze.

b. Store test strips in the tightly capped vial in which they are packaged.

c. Test strips are stable until the expiration date on the vial.

d. Discard outdated test strips, or if expiration date is missing or illegible.

e. Use test strips at temperatures between 16º and 35º C (61º and 95º F) and between 10 – 80% relative humidity.

f. Verify the test strip code information whenever a patient or quality control test is performed.

g. Close the vial cap immediately after removal of a test strip.

h. Test strips should be used immediately after taken out of the container.

i. Do not remove strips from original container and transfer them in another container.

2. Accu-Chek Inform II Glucose Control Solutions 2-levels, Level 1 and Level 2

a. Store at room temperature. Do not freeze.

b. Controls are stable for three months after opening or until the expiration date, whichever comes first.

c. Write the new expiration date on the vial label after opening.

d. Discard any outdated glucose control solutions

3. Accu-Chek Comfort Curve Linearity Test Kit

Equipment

Accu-Chek Inform II Glucose Meter

Special safety precautions

Observe Universal Precautions during the collection and processing of specimens, during equipment maintenance, cleaning and decontamination process.

• Use Personal Protective Equipment, including gloves, eye protection and fluid resistant lab coats.

• Wash Hands after removal of gloves.

Sample and Sample Preparation

1. Capillary whole blood

• First drop of blood must be wiped off.

• Use the second drop of blood for testing.

Note: The same drop of blood can be used to repeat patient testing.

• Sample must be tested immediately after collection.

• Sufficient sample size is required to ensure accurate results.

2. Venous whole blood collected in EDTA tube.

• Specimen should be mixed thoroughly before testing

• Testing should be performed within 30 minutes of specimen collection to avoid glycolysis.

3. Venous whole blood collected in red top or serum separator tubes (gold) are acceptable if blood is used immediately before the clotting process begins.

4. Arterial whole blood collected in heparinized tube.

• Caution should be taken to clear arterial lines before blood is drawn and dosed on the test strip.

• Specimen should be mixed thoroughly before testing

• Testing should be performed within 30 minutes of specimen collection to avoid glycolysis.

NOTE: Iodoacetate or fluoride/oxalate should not be used as a preservative.

Quality control:

1. Run two levels of control materials at the following intervals

a. Every 24 hours

b. Whenever a vial of strips has been left open

c. If questionable test results are displayed repeatedly

d. When test results contradict clinical symptoms

e. If the Accu-Chek Inform II has been dropped.

f. After the Accu-Chek Inform II System has been reset.

Note: Reset must only be done by the ATC or designee

2. In areas where the Accu-Chek Inform II System is not being used daily, perform quality control before patient testing.

Procedure:

Instrument Set up

Completed by Ancillary Testing Coordinator or designee.

1. Set-up the Accu-Chek Inform System to store the following information:

a. Test Result

b. Operator ID

c. Control levels and Lot Information

d. Test Strip Information

e. Test Time and Date

f. Comment(s)

g. Meter inventory

Linearity Testing

Performed by the Ancillary Testing Coordinator or designee.

2. Perform Linearity testing:

a. Before Accu-Chek Inform is put to use.

b. With each new lot of strips.

c. At least every six months.

d. Anytime the Accu-chek Inform System has been repaired.

e. When controls begin to reflect an unusual trend or are consistently out of range.

3. Record and retain the linearity results and graphs on the RALS Web-3 Glucose Management System for at least two years, where data and graph are reviewed electronically but can be printed as needed.

The linear reporting range of the Accu-Chek Inform II is 18 - 600 mg/dL.

Problem Reporting

If the Accu-Chek Inform II System should fail during any of its tasks call the Ancillary Testing Coordinator at 909-503-2865.

Instrument

Maintenance, Cleaning and

Decontamination

To be performed by testing personnel Observe Universal Precautions during decontaminating Accu-Chek Inform II meters and its base unit.

Warning: - DO NOT spray the meter or its base unit directly with solutions, this could enter the case and damage the electronic components.

- DO NOT disinfect the meter while performing patient or control testing.

- Use only Sani-Cloth Bleach Disposable Wipes or Super Sani- Cloth Disposable Germicidal wipes to disinfect the meters.

- Sani-Cloth Bleach Germicidal Disposable wipes must be used to disinfect meters that are used for patient suspected or known infection due to C. Difficile.

Procedure:

Note: Squeeze off excess disinfecting solution before wiping.

1. Wipe the meters three times vertically, three times horizontally and around with Sani-Cloth Bleach Disposable Germicidal Wipes or Super Sani-Cloth

Disposable Germicidal wipes after each patient testing event while avoiding the strip port.

Note: Use Sani-Cloth Bleach Disposable Germicidal Wipes if there is visible presence of blood on the meter.

2. Allow the surface of the meter to remain damp, contact time of 4 minute for

Sani-Cloth Bleach Disposable Germicidal wipes or 2 minutes for Super-

Sani Germicidal Disposable wipes or 4 minutes for Sani-Cloth Bleach

Disposable Germicidal Wipes for meters used for known or suspected carrier of C. dificile before wiping with clean gauze or paper towel to dry.

4. Visibly verify that the meter is thoroughly dried before returning to its base or before use.

5. Wipe base unit with Sani-Cloth Bleach Germicidal wipes or Super Sani-Cloth wipes avoiding the electrical port.

Note: Use Sani-Cloth Bleach Germicidal Disposable wipes if there is visible presence of blood on the base unit.

6. Visibly verify that the base unit is thoroughly dried before returning the meter.

Maintenance-

Disinfecting Accessory Box

7. Wipe the accessory box thoroughly with Sani-Cloth Bleach Germicidal

Disposable Wipes or Super-Sani Cloth Disposable Germicidal Wipes.

Note: Use Sani-Cloth Bleach Germicidal Disposable wipes if there is visible presence of blood.

8. Allow the accessory box to air dry.

Note: Do not place the meter in a wet or damp accessory box

Calibration

The system is calibrated by the manufacturer using venous blood containing various glucose concentrations.

Control Testing

Notes: Wear gloves when collecting specimens or testing patients and controls.

Clean the meter following steps specified under the “MAINTENANCE” section.

1. Press the power ON button.

2. Scan operator ID.

3. Scan Control solution.

4. Scan bottle of strip

5. Remove a test strip from the vial and immediately replace the cap.

6. When the flashing strip icon appears, gently insert the test strip.

a. Insert the end with the silver bars; the yellow target area (test strip window should be facing up).

Note: Insert test strip BEFORE dosing.

7. When the flashing drop icon appears on the meter display, obtain desired control material and touch and hold drop of liquid to the front edge of the yellow target area.

8. The fluid is drawn into the test strip automatically.

9. Once sufficient control solution has been detected, the meter beeps and the measurement begins. An hourglass will appear on the display while waiting for the result.

10. Enter “Cleaned Monitor” comment and any necessary QC result comments. The meter allows entry of two additional preprogrammed comments and one custom comment, if necessary.

11. Press the check button to accept the QC result and return to the Main Menu screen in order to run the next test.

12. Remove the test strip from the meter and discard it accordingly, following infection control policy.

13. Test the other Control solution repeat steps 3-12 above.

If a quality control test result falls within the acceptable (PASS) control range, it is acceptable to proceed with patient testing.

Quality Control

Failures

14. If a quality control test result falls outside of the acceptable control range

(FAIL), complete the following corrective actions:

a. First “FAIL”

• Check expiration dates on reagent strips and controls

• Re-mix the controls prior to retesting

• Add comment “Will Repeat the Test” and

• Repeat one time

b. Second “FAIL”

• Open a new bottle of strips and use different bottle(s) of controls and

• Repeat one time NOTE Control solutions from other ward/clinic can be used

c. Third “FAIL”

• Do Not Use the failed glucometer for patient testing.

• Write down what is wrong with the meter

• Notify the Ancillary Testing Coordinator

• Bring the meter with the note to the lAncillary Testing

Coordinator or designee for futher assesment .

Note:. Accuchek meters from other ward/clinic can be borrowed if needed.

Backup meters are available in the laboratory

WARNING:

• If the Accu-Chek Inform II meter should fail during any of its tasks call the Ancillary Testing Coordinator at 909-503-2865 DO NOT CALL BIOMED nor log in a call for IT.

Patient

Fingerstick Sample

Collection

Wear gloves when collecting specimens or testing patients and controls.

1. Gather the following items and take to the patient’s bedside:

• Accu-Chek Inform II meter

• Accu-Chek Inform II test strips.

• Single-use, disposable lancets

• Alcohol swab

• Cotton ball, tissue, or gauze for wiping finger after stick

• Disposable gloves

2. Explain the purpose of the test and the steps of the testing procedure to reassure the patient.

3. Wash your hands and put on disposable gloves prior to blood collection.

4. Clean the puncture site with an alcohol swab and allow it to dry thoroughly.

Note: Residual alcohol at the skin puncture site must be dry or an inaccurately high result may occur.

5. Make certain to have sufficient amount of sample to cover the entire yellow portion of the strip to ensure accurate results.

6. Capillary sample must be tested immediately after collection.

7. Discard disposable lancets according to the facility policy for the disposal of bio hazardous sharps

Patient Testing

Wear gloves when collecting specimens or testing patients and controls.

1. Press power ON button.

2. Enter (or scan) your operator ID.

3. Select Patient Test.

4. For Inpatient scan patient’s armband.

5. For Outpatient use two patient identifiers before manually entering the patient’s full Social Security Number into the meter.

6. Verify and confirm patient’s ID at the meter

7. Scan or confirm the strip lot#

8. Touch check to continue.

9. Remove a test strip from the vial. Immediately replace the cap on the vial.

When the flashing strip icon appears on the meter display, gently insert test strip with the yellow target area or test strip window facing up. (Insert the end with the gold bars.)

Note: Insert test strip into the meter BEFORE dosing.

10. When the flashing drop icon appears on the meter is displayed, obtain a blood sample as described on Patient Fingerstick Sample Collection

11. Use whole blood capillary, venous, or arterial blood sample. (Follow the manufacturer's instructions when using a lancet device.)

Warning: When using Venous or Arterial sample the Sample and Sample Preparation must be strictly followed

12. Touch the top portion of the test strip to the drop of blood and hold until yellow target area is completely filled. The blood is drawn into the test strip automatically.

13. Once sufficient blood has been detected, the meter beeps and the measurement begins. An hourglass will appear on the display while waiting for the result.

14. Enter comment “Cleaned Monitor” and “Action Taken” after each patient testing.

15. Enter up to three preprogrammed comments and one custom comment, if necessary. Then press the check button to accept and record the result and return to the Main Menu screen in order to run the next test.

16. Remove the test strip from the meter and discard it accordingly.

17. Press the power OFF button to turn the Accu-Chek Inform II meter off.

18. Clean the meter following the “Maintenance” procedure.

Note: Clean the meter after each patient testing.

19. Verify that meter is dry before returning to the base unit to download results.

20. Remove gloves and dispose of them according to the facility’s infection control policy. Wash hands thoroughly with soap and water.

21. Document the blood glucose result according to policy.

Interpretation and Decision

Making Criteria

1. The Analytical Measurement Range (AMR) of the glucometer instrument is

18 - 600 mg/dL. Report values that fall outside this range as “<18 mg/dL” or “> 600 mg/dL.”

2. If LO is displayed, the blood glucose result may be lower than the reading range of the meter (<18 mg/dL).

If HI is displayed, the blood glucose result may be higher (>600mg/dL) than the reading range of the meter.

Proceed as follows:

a. Repeat testing.

b. If result is still the same, contact physician and follow ward policy

(ies) for treatment of the patient.

c. Draw lab glucose for confirmation.

d. IF physician opt for no blood to be drawn for laboratory testing it should be noted in the template.

3. CRITICAL VALUES: <50 mg/dL and >400 mg/dL

a. Repeat all critical values immediately or within 15 minutes

b. Report all critical values to a physician immediately. Note the date and time of testing, name of physician notified, name of who notified the event and document in CPRS using the

HYPO/HYPERGLYCEMIC Template.

c. It is recommended to draw Laboratory glucose for confirmation, then document in Hypo/Hyperglycemic template.

4. If first (1st) and repeat (2nd) results of glucose values >400 mg/dL are not within 10%, draw lab glucose.

5. If first (1st) and repeat (2nd) results of glucose values <60 mg/dL are not within +/- 6 mg/dL, draw lab glucose.

Note: Point of Care whole blood glucose and laboratory result/s will be reviewed accordingly.

Note: Multiple meters can be used to test from the same drop of blood

Warning:

• If validity of the glucose meter results is questioned and does not match patient’s symptoms, DO NOT USE the result; repeat test using another meter or draw for lab glucose.

• Run liquid controls on the meter/s that give questionable result.

6. Note all actions taken, including follow up to critical result/s in the Hypo/Hyperglycemic template in CPRS. Document all follow up as addendum in CPRS.

Recording and Reporting of Results

1. In comments, select “Action Taken” and Acknowledge in CPRS by using the

Hypo/Hyperglycemic template for:

• all hypoglycemic result of <60 mg/dL (includes critical low results of <50 mg/dL),

• critical results of >400 mg/dL,

• out of meter measurable range result of “LO” (<18mg/dl) and

• out of meter measurable range result of “HI” (>600 mg/dL)

2. Download all results to the Central Glucose Management System

(accomplished automatically as soon as glucometer is returned to its base unit).

• Results will be uploaded directly to electronic patient’s chart.

• All critical values are reviewed on the RALS/ALERE Web Glucose

Management System by the Ancillary Testing Coordinator or designee.

• Results with invalid ID will not be corrected and uploaded.

• Manual entry of results to Vista is only done by Ancillary Testing coordinator or designee.

The Accu-chek Inform retains 4000 results

Proficiency Testing (PT)

The laboratory is enrolled in a College of American Pathologist (CAP) program to obtain unknown samples every 4 months which are used to assess testing personnel’s, facility’s and instrument’s proficiency.

• PT results and records are reviewed by the Ancillary Testing Coordinator or designee and retained in the RALS/ALERE Glucose Management

System.

Wear gloves when testing proficiency samples.

1. Press the power ON button.

2. Scan operator ID, then press the check button.

3. Press the check button to display the Main Menu 2 screen.

4. Select “proficiency.”

5. Enter or scan the sample ID and press the check button.

6. Verify the strip code information by pressing ” check button.

7. Perform the proficiency test in the same manner as patient testing.

8. Enter a comment if necessary.

9. Remove the used strip and discard as Bio hazardous waste.

10. Press the forward arrow button to navigate to the Main Menu 2 screen in order to run the next sample.

Press the power OFF button to turn the meter off before returning immediately to the base

Method

Limitations

Method Limitations Continued

NOTE: It is recommended to draw blood to be submitted and tested at the main laboratory when these limitation/s are present.

1. The performance of this system has not been evaluated in the critically ill.

2. In situations where peripheral circulation is impaired, collection of capillary blood from the site is not advisable as the results might not be a true reflection of the physiological blood glucose level. This may apply during severe dehydration as a result of diabetic ketoacidosis or hyperglycemic hyperosmolar non-ketotic syndrome, hypotension, shock, decompensated heart failure NYHA Class IV or peripheral arterial occlusive disease.

3. Do not use on patients who are receiving intravenous ascorbic acid which results in blood concentration of ascorbic acid >3mg/dL will cause overestimation of blood glucose results.

4. Hematocrit should be between 10-65%.

5. The Accu-Chek Inform System has been tested at altitudes ranging from sea level to 10,150 feet.

6. In acute cases, POC glucose testing via capillary sample may have occurred before the patient could be evaluated for the “Limitations” criteria. Glucose testing should be switch to lab draw protocol as required/recommended and monitor patient for any adverse events.

7. The following compounds, when determined to be in excess of their limitations, may produce elevated glucose results:

Compound Limitation

Galactose >15 mg/dL

Lipemia (Triglyceride) >1800 mg/dL

Ascorbic Acid >3 mg/dL

References

1. American Diabetes Association Position Statement, Diabetes Care, Vol. 19 (suppl.

1), p. S4 (1996)

2. Roche Diagnostics Operator’s Manual for Accu-Chek Inform II, 2013.

3. Roche Diagnostics package insert for Accu-Chek Inform II Strips, 2018.

4. Roche Diagnostics package insert for Accu-Chek Inform II Controls, 2018.

Appendices

POC-S8531.A3 NURSING JOB AID FOR ACCU-CHEK INFORM II WHOLE

BLOOD GLUCOSE TESTING

Document Distribution

Original: Copies:

Ancillary Testing Manual - Volume 2

Ancillary Testing Manual – CBOC Section

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