S02 ATTACHMENT D.26 - FAV ATC 1 WHOLE_BLOOD_CLUCOSE_TESTING_CONTROLLED.pdf

FAV ATC 1 Whole Blood Glucose Testing

Copy of version 2.0 (approved and current)

Last Approval or Periodic Review Completed

11/7/2022

Next Periodic Review Needed On or Before

11/7/2024

Effective Date 11/7/2022

Controlled Copy ID 26037

Location No Physical Location

Organization Veterans Health System of the Ozarks

Comments for version 2.0 Added cleaning and disinfecting, analytical measurement and clinical reportable ranges. Rearranged sections and reformatted.

Approval and Periodic Review Signatures

Type Description Date Version Performed By Notes

Approval Lab Director 11/8/2022 2.0 Constantine Theoharis

Approval Lab Director 11/7/2022 2.0 Constantine Theoharis

Approval ATC 11/7/2022 2.0 Jenifer Welsch

Approval Lab Director 6/13/2022 1.0 Constantine Theoharis

Periodic review

Designated Review er

3/9/2022 1.0 Patricia Gregg

Periodic review

Designated Review er

3/3/2022 1.0 Jenifer Welsch Recorded w hen document added to MediaLab

Approval Lab Director 3/23/2017 1.0 Dr. R Levy Recorded w hen document added to MediaLab

Approvals and periodic reviews that occured before this document was added to the MediaLab Document Control system may not be listed.

Version History

Version Status Type Date Added Date Effective Date Retired

2.0 Approved and Current Major revision 11/4/2022 11/7/2022 Indefinite

1.0 Retired First version in Document Control 3/3/2022 3/23/2017 11/7/2022

Whole Blood Glucose Testing

Principle

The ACCU-CHEK Inform II system quantitatively measures glucose in whole blood. The enzyme on the test strip converts the glucose in the blood sample to gluconolactone. This reaction creates a harmless electrical DC current that the meter interprets for a glucose result. The sample and environmental conditions are also evaluated using a small AC signal.

Extent of Use

The ACCU-CHEK Inform II system is used in the Veterans Health Care System of the Ozarks to quantitatively measure glucose in fresh venous, arterial and capillary (fingerstick) whole blood.

This procedure applies to all personnel trained to operate the ACCU-CHEK Inform II. This system is not to be used on “critically ill” patients.

Critically Ill Patient

Veterans Health Care System of the Ozarks (VHSO) has defined critically ill patients as “patients on mechanical ventilation with a mean arterial pressure (MAP) of less than 60 mmHg despite the use of vasopressors”. Capillary glucoses are not to be performed on these patients, a venous draw and glucose performed by the laboratory is required.

Standard Precautions

1. Hand Hygiene – hands must be washed before and after each patient test and gloves must be worn during patient testing. The meter should be disinfected between patients.

2. Single Use Devices – The lancets are single use devices and must be discarded after use.

These devices should not be used more than one time.

Equipment and Materials

ACCU-CHEK Inform II meter

Lancet device

Alcohol swabs

Cotton balls

Gloves

ACCU-CHEK Inform II Strips

ACCU-CHEK Inform II Glucose Control Solutions, High and Low

Super-Sani Germicidal Disposable Wipes (for cleaning)

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Gauze squares or paper towels (for cleaning)

Reagent Storage and Handling Requirements

1. Test Strips:

Use the test strips at temperatures between 61-95oF (16-35oC).

Use the test strips between 10-90 % relative humidity. Humidity is the amount of dampness in the air.

Store the test strips at temperatures between 39-86oF (4-30oC).

Store unused test strips in the original container with the cap closed. Do not remove test strips from the test strip container and put them into another container such as a plastic bag or pocket, etc.

Close the container tightly immediately after removing a test strip to protect the test strips from humidity.

Use the test strip immediately after removing it from the container.

Discard test strips that are past the expiration date printed on the test strip container.

If the expiration dates is missing or illegible, do not use the test strips.

Do not apply blood or control solution to the test strip before inserting it into the meter. If a result appears before applying blood or control solution, do not act on that result.

2. Inform II Control and linearity solutions expire on the date printed on the vial label, or 3 months from opening, whichever comes first. Whenever an operator opens a vial of controls or linearity solution, he/she must handwrite the expiration date (MM/DD/YY) on the vial. That date will be either 3 months from opening or the date printed on the vial label, whichever comes first. Do not use after the expiration date printed on the vial label.

Quality Control

Quality control testing is performed as a primary means of ensuring on-going proper performance of the ACCU-CHEK Inform II system. Two levels of quality control are tested on the following occasions:

One time per 24-hour period of patient testing.

When a new vial of test strips is opened and placed into service.

If the cap is left off the vial of test strips.

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

When troubleshooting the system.

At room temperature, 95% of low and high glucose control solution results should fall within range. Results that fall within the range are indicated by PASS on the meter display. Results that are not within range are indicated by FAIL. If results fall outside the expected range, repeat the test and enter a comment in the meter of “Repeated Test”. Results that fall outside the expected range may indicate:

Procedural error

Old or contaminated glucose control solution.

Test strip deterioration.

Unit malfunction.

Quality Control Procedure

1. Turn the glucometer on.

2. Enter, or scan, your operator ID. Note: If the operator ID you enter is not accepted, attempt to re-enter it. If it is still rejected, you may be due for recertification. Contact the Ancillary Testing Coordinator (ATC). Do not attempt to perform tests under another operator’s ID.

3. From the Main Menu, touch Control Test.

4. Scan the glucose control solution vial barcode. (If barcode scan is invalid, consult the ATC at ext. 65289, or Back-up ATC at ext. 65273)

5. Scan the test strip vial barcode. (If barcode scan is invalid, consult the ATC at ext. 65289, or Back-up ATC at ext. 65273)

6. The meter will display a picture of a test strip with a downward flashing arrow on the meter indicating that you are ready to insert a test strip into the meter. Remove a test strip from the vial and immediately recap the vial. Insert the test strip into the meter in the direction of the arrows and with the “ACCU-CHEK” lettering facing upward. The meter will display a flashing drop above the test strip icon when the test strip is properly inserted indicating that you are ready to apply control solution.

7. Apply control solution to the front edge of the test strip. The solution will fill the yellow sample chamber by capillary action. Do not apply sample to the top of the test strip. Once sufficient sample has been detected, the measurement begins. An hourglass icon indicates

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8. The measurement is complete when the result is displayed on the meter screen. A numerical value will not be displayed. PASS will be displayed if the value is in range and FAIL if it is not. Any result that shows an “out of range” message or “Fail” is an indication that the system may not be performing correctly for patient testing.

9. Remove the test strip and dispose of it in a bio-hazard waste can.

10. Touch the comment button ( ) to enter an appropriate comment(s) as required. ALL “FAIL” results must be repeated and have a comment entered to show that there was an action taken to address the failed QC result.

11. Touch the button to confirm the result and place the meter in the base unit to send the result and record the result into the electronic data management system. The base unit also charges the meter.

Interpretation of Quality Control Results

1. Results are displayed on the screen as Pass or Fail. Any result that shows an “out of range” message or “Fail” is an indication that the system may not be performing correctly for patient testing.

2. Patient testing may not be performed if quality control testing results are not within acceptable limits and the meter will not display the patient testing option if scheduled quality control results exceed acceptable limits.

Patient Identification

Correct patient identification is absolutely essential. The patient must be positively identified before the whole blood glucose testing is performed. This identification must include two the following pieces of information: Patient Name, Social Security Number, Date of Birth.

1. Inpatient: Ask the patient to identify himself/herself and check the armband. If the patient lacks an armband ask the patient to verify his/her name and full SSN.

2. Outpatient: Ask the patient for his/her VIC card and verify their full name and ask for their full SSN. If the patient does not have their VIC card with them ask them to recite their full name and full SSN.

Patient Specimen Type

A drop of fresh, whole blood is required to perform a whole blood glucose test. When collecting any type of sample, universal blood collection precautions must be followed.

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Capillary blood from a fingerstick is preferred. This sample should be tested immediately.

Venous, neonatal, or arterial blood may be used if drawn by healthcare professionals.

Acceptable anticoagulants are Lithium or Sodium Heparin and EDTA. Serum separator tubes are acceptable if whole blood is used immediately. Iodoacetate or fluoride-containing anticoagulants are not recommended. Venous and arterial samples should be tested within 30 minutes of drawing to minimize the effect of glycolysis.

Patient Test Procedure

1. Take the meter and testing supplies to the patient location.

2. Wash hands and don personal protective equipment (gloves, gowns, etc.) as required by infection control and isolation policies and procedures.

3. Greet and identify the patient according to the Patient Identification section of this procedure.

4. Explain the procedure to the patient.

5. Assess the patient for compromised peripheral blood flow. Fingertips should be warm and pinkish when the hand is gently massaged from the palm outward to the fingertips.

Fingertips should not appear pale, bluish or mottled. Patients with compromised peripheral blood flow are not good candidates for fingerstick testing.

6. Select the finger site for puncture. It is preferred to select the side of a middle or ring finger that has not been punctured recently.

7. Enhance blood flow to the selected puncture site by means of:

a) Warming the intended puncture site.

b) Instructing the patient to flex and move the arm, wrist, hand and fingers while you are assembling your supplies and preparing the system for testing.

c) Positioning the intended puncture site below heart level.

d) Gently massaging in an outward (distal) direction from the palm and the base of the finger to the fingertip.

8. Turn the glucometer on.

9. Enter, or scan, your operator ID. Note: If the operator ID you enter is not accepted, attempt to re-enter it. If it is still rejected, contact the ATC or your nursing preceptor as you may need to recertify. Do not attempt to perform tests under another operator’s ID.

10. From the Main Menu, touch Patient Test.

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11. Enter the patient ID by scanning the patient’s wristband barcode or the patient’s VIC card barcode. If the patient does not have either a wristband or their VIC card, enter the patient ID by pressing the number keys on the touchscreen using your fingertip. The preferred method of entering the patient ID is by scanning the patient’s barcode.

12. Confirm that the meter is coded to the same test strip code that is printed on the test strip vial. (Contact the ATC if you are unable to confirm the correct test strip code.)

a) If correct, touch the button.

b) If incorrect, touch the button to select a different test strip lot number.

13. You will now see a picture of a test strip with a downward flashing arrow on the screen indicating that you are ready to insert a test strip into the meter.

14. Remove a test strip from the vial and immediately recap the vial. Insert the test strip into the meter in the direction of the arrows and with the “ACCU-CHEK” lettering facing upward. The meter will display a flashing drop above the test strip icon when the test strip is properly inserted indication that you are ready to apply a blood sample.

15. Clean the puncture site well with an alcohol wipe to remove potential contaminants. Allow the puncture site to dry completely before puncturing.

16. Advise the patient of imminent puncture.

17. Perform fingerstick on palmar surface of the finger’s distal phalanx – not on finger tip, side or pad. Puncture should occur across the fingerprints, not parallel to them.

18. Hold the body of the lancet device and remove the lancet cap.

19. Place the end of the lancet device against the patient’s finger and press the lever. The needle automatically retracts after use.

20. Hold the puncture site downward and gently apply intermittent proximal to distal pressure along the finger toward the puncture site to express a blood drop. Do not apply strong repetitive pressure at the fingertip as it may cause hemolysis or contamination of the sample with tissue fluid and may lead to questionable results.

21. Wipe away first drop of blood with dry cotton ball or gauze, since the first drop is most likely to contain excess tissue fluid. (Use of alcohol prep may cause dilution of sample.)

22. Apply a well-formed drop to the front edge of the ACCU-CHEK Inform II test strip. The sample will fill the yellow sample chamber by capillary action. Do not apply sample to the top of the test strip.

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23. Once sufficient sample has been detected, the measurement begins. An hourglass icon indicates that the measurement is in process.

24. After the sample has been obtained, apply gentle pressure to the puncture with a clean gauze square or cotton ball for several minutes. If the patient is conscious and capable, enlist the patient’s assistance with applying pressure.

25. The measurement is complete when the result is displayed on the screen. Depending upon how high or low the result is, it may appear in a numeric or non-numeric format.

26. Remove the test strip and dispose of it in a bio-hazard receptacle or sharps container.

27. Touch to enter up to three appropriate comment(s). (Note: ALL critical results must be repeated and have documentation of notification to provider)

28. Touch the button to confirm the result.

29. Check the fingerstick site to ensure it is no longer bleeding before leaving the patient bedside.

30. Discard all sample collection and testing materials immediately after use in an appropriate sharps or biohazard container.

31. A new fingerstick should be performed for any repeat testing to provide a fresh sample.

32. Do not place the meter in bedding while conducting testing. Contact with bedding may wick blood from strip and cause erroneous results.

33. Wash hands before leaving the patient room.

34. Clean and disinfect according to the Cleaning/Disinfecting the Glucometer and Base Unit procedure below.

35. Place the meter back in the base unit to automatically transfer results to the patient’s chart. The base unit also charges the meter.

Reference Range

70 – 110 mg/dL

Critical Values

The glucometer will flag as critical low any value less than 60.

The glucometer will flag as critical high any value greater than 500.

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When a value of <60 or >500 is displayed, you must repeat the test, select the “CV given to” comment, enter a custom comment with the provider’s name and title and notify the provider.

RNs may also enter a comment in BCMA if they have access to this system.

It is recommended that unexpected critical values, especially those obtained on asymptomatic patients, are verified by sending a separate specimen to the laboratory for verification.

Reportable Range

30 – 600 mg/dL

The meter is configured to display a non-numeric result (LO/HI; measurement range default) for tests that exceed the established reportable range.

The analytical measuring range for the Accu-Chek Inform II meter is 10 – 600 mg/dL.

Reporting Format

Results are reported in milligrams per deciliter (mg/dL). Test results, and QC results, are transferred to the RALS server when the meter is placed in its base unit. The base unit has two purposes:

1. Recharge the meter battery pack

2. Provide a route for transferring data or configurations through a serial port

Cleaning and Disinfecting the Glucometer and Base Unit

The Accu-chek Inform Meter must be cleaned after each patient use. The base unit and accessory box are cleaned as needed. Report any deterioration to the Ancillary Testing Coordinator at extension 65289 or 65273.

Do NOT:

Clean or disinfect the meter while performing any type of test.

Allow pooling of liquid on the touch screen.

Spray anything onto the meter or base unit.

Immerse the meter or base unit in liquid.

Get liquid into the strip port! If liquid does get into the test strip port, immediately dry the components with a dry cloth or gauze pad. If solution is allowed to collect in any meter

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Wipe the electrical connectors on the back of the base unit.

Use any cleaning and disinfecting product other than that which is recommended by the manufacturer, identified in this procedure and provided through normal procurement policies and procedures.

Accu-check Inform II Meter

1. Don clean gloves before cleaning the meter.

2. Place the meter on a level surface prior to cleaning.

3. Power off the meter.

4. Remove a germicidal wipe from it packaging. Squeeze the wipe out and blot on a dry paper towel to remove any excess solution from it before disinfecting the surfaces of the meter.

5. Use a germicidal wipe to disinfect by gently wiping the surfaces of the meter three times vertically and three times horizontally. Use additional wipes as needed. Note: Carefully wipe around the meter test strip port area, making sure that no liquid enters the test strip port.

6. Allow the surfaces of the meter to remain damp with the disinfecting solution for the manufacturer’s recommended time.

7. Dry the meter surfaces thoroughly with a soft cloth or gauze after cleaning. Visually verify that no solution is seen anywhere on the meter at the completion of cleaning.

8. Discard gloves after use.

Accu-chek Inform II Base Unit

1. Don clean gloves before cleaning the base unit.

2. Place the base unit on a level surface prior to disinfecting.

3. Unplug the base unit.

4. Remove a germicidal wipe from it packaging. Squeeze the wipe out and blot on a dry paper towel to remove any excess solution from it.

5. Use a germicidal wipe to disinfect by gently wiping the surfaces of the base unit. Use additional wipes as needed. Note: Do not wipe the electrical connectors on the back of the base unit.

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6. Allow the surfaces of the base to remain damp with the disinfecting solution for the manufacturer’s recommended time.

7. Dry the base unit surfaces thoroughly with a soft cloth or gauze after cleaning. Visually verify that no solution is seen anywhere on the base unit at the completion of cleaning.

8. Discard gloves after use.

Accu-check Inform II Accessory Box

1. Don clean gloves before cleaning the tote.

2. Place the accessory box on a level surface prior to disinfecting.

3. Remove a germicidal wipe from it packaging. Squeeze the wipe out and blot on a dry paper towel to remove any excess solution from it before disinfecting the surfaces of the accessory box.

4. Use a germicidal wipe to disinfect by gently wiping the surfaces of the accessory box. Use additional wipes as needed.

5. Allow the surfaces of the accessory box to remain damp with the disinfecting solution for the manufacturer’s recommended time.

6. Dry the accessory box surfaces thoroughly with a soft cloth or gauze after cleaning. Visually verify that no solution is seen anywhere on the accessory box at the completion of cleaning.

7. Discard gloves after use.

Procedure Notes

1. For in vitro diagnostic use only.

2. Good sample quality is essential for reliable results. The following tips will help you to optimize the quality of a fingerstick capillary sample:

a. Assess the patient for signs of reduced peripheral circulation such as cold hands, pale, mottled or bluish nail beds and administration of vasopressor medications. If peripheral circulation is impaired, collection of capillary blood from approved sites is not advised, as the results might not be a true reflection of the physiologic blood glucose level. This may apply in the following circumstances: severe dehydration as a result of diabetic ketoacidosis, or due to hyperglycemic hyperosmolar non-ketotic syndrome, hypotension, shock, decompensated heart failure NYHA class IV, or peripheral arterial occlusive disease.

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Note: Glucometers are not to be used on critically ill patients. A venous draw with glucose performed by the laboratory is required in those circumstances.

b. Always take basic steps to stimulate blood flow to the intended puncture site. Even if the patient’s peripheral circulation is not impaired this will help you to procure a sufficient and free flowing sample, especially in patients who are sedentary. Common methods for stimulating blood flow include:

i. Warming the site

ii. Positioning the hand below the heart

iii. Gently massaging the hand by stroking from the palm outward to the fingertip

iv. Asking the patient to move and flex his/her arm, wrist, hand and fingers while you are gathering supplies and preparing the system for testing.

c. Be sure to allow the cleansing agent to completely dry before puncturing the intended site.

d. Wipe away the first drop of blood. This is Advantageous because it ensures that the alcohol is dry, it stimulates blood flow and clears interstitial fluid from the sample.

e. Do not attempt to express blood from a previous puncture site even if it still appears to be bleeding because it is likely that the clotting process has begun and may alter the sample matrix. A fresh puncture should be made for every test.

3. Do not place the meter on bedding after applying blood to the test strip. This can cause the blood to be wicked out of the test strip by the bedding.

4. Recap the test strip vial immediately after you remove the test strip you plan to use. Never use test strips found loose outside the vial. Discard any vial of strips that you find uncapped.

5. If the patient is experiencing symptoms which are not consistent with the blood glucose result obtained and you have followed the test procedure as described, follow the hospital’s policy for treating the symptoms and confirm the blood glucose results with a laboratory test.

6. Never make significant changes to the patient’s medication program or ignore physical symptoms without consulting a physician.

Limitations of the Procedure

The ACCU-CHEK Inform II system is used within its limitations as described by the manufacturer’s most current literature on interference and limitations – See list below and manufacturer’s ACCU-

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CHEK Inform II test strip package insert and literature attached in the appendix section of this manual.

The ACCU-CHEK Inform II test strips are for testing fresh capillary, venous, arterial, or neonatal whole blood. Cord blood samples cannot be used.

Hematocrit should be between 10 – 65%.

Lipemic samples (triglycerides) in excess of 1800 mg/dL may produce elevated results.

Blood concentrations of galactose > 15 mg/dL will cause overestimation of blood glucose results.

Intravenous administration of ascorbic acid which results in blood concentrations of ascorbic acid >3 mg/dL will cause overestimation of blood glucose results.

If peripheral circulation is impaired, collections of capillary blood from the approved sample sites is not advised as the results might not be a true reflection of the physiological blood glucose level. This may apply in the following circumstances: severe dehydration as a result of diabetic ketoacidosis or due to hyperglycemic hyperosmolar non-ketotic syndrome, hypotension, shock, decompensated heart failure NYHA Class IV, or peripheral arterial occlusive disease.

This system has been tested at altitudes up to 10,000 feet.

The performance of this system has not been evaluated in the critically ill and this glucometer should not be used on a critically ill patient. For these patients a venous draw and glucose performed by the laboratory is required.

Troubleshooting

If the meter fails to function at any point in the procedure or if you get an error message associate with the result, make a note of the malfunction or error message and attempt to repeat the test. If the error persists, sequester the meter and test strip vial involved and deliver them to the Ancillary Testing Coordinator in the laboratory. You may also contact the ATC at extension 65273, or extension 65289. During “off shifts”, please call the laboratory at ext. 65272. The laboratory maintains several back-up meters and one may be checked out when bringing a meter back.

1. If the error message “Strip Defect Error” appears on the display, the test strip may be defective or the blood glucose result may be extremely low and below the meter’s measurement range. Repeat the blood glucose test using a new test strip. If error appears again try a new vial of strips.

2. If the meter displays “Type Bad Dose”, there may be insufficient amount of blood on the test strip. Repeat the test using a new test strip, ensuring proper sample application.

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3. Guidance for interpreting on-screen message and error codes:

All error messages displayed by the system have a letter identifying the message type, a number and a description of the error to help the operator take action to resolve the problem. The different message types are in the table below.

E Identifies the notification as an Error. The information notifies the operator that an error has occurred.

W Identifies the notification as a Warning. The information does not block the operator from continuing, but rather gives the operator information that may suggest an alternate workflow is required.

I Identifies the notification as Informational only. Informational notifications present the operator with contextual information, and allow the operator to proceed after confirming the notification.

D Identifies a Decision point. Decision notifications provide the operator with a choice based on contextual information.

4. Troubleshooting questionable results: Consider whether the result is consistent with the patient’s history and clinical presentation. Take the following action if you question the reliability of the result for any reason:

a. Add a comment(s) to the result indicating that the result is in question, or select the PROCEDURE ERROR comment.

b. Perform quality control testing using the same meter and test strips.

c. If quality control test results are within range, repeat the patient test using the same strips and meter.

d. If the quality control tests are not within range, sequester the meter and test strip vial involved and contact the ATC at ext. 65273, or ext. 65289 for advanced troubleshooting. After hours call the laboratory at ext. 65272.

e. Repeat patient testing using another meter and test strip vial that have passed routine quality control testing.

Additional Facts

1. In Measurement mode only: If you are performing a test (patient, control, proficiency or linearity), the meter will power off after 10 minutes of inactivity (no screen touches), independently of configured automatic power off time. If a result is already present, the

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2. Test results are also saved when the meter is powered off in the results screen or when it powers off automatically.

References:

ACCU-CHEK Inform II Blood Glucose Monitoring System Operator’s Manual, Version 3.0, 2013-03 Roche Diagnostics.

ACCU-CHEK Inform II Test Strips and 1 Code Key Product Insert, 2013 Roche Diagnostics.

ACCU-CHEK Inform II Controls Product Insert, 2012 Roche Diagnostics.

Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens;

Approved Standard – Fifth Edition, H4-A5, Volume 24 No. 21, Clinical and Laboratory Standards Institute.

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