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Director Signature__________________________________ Date___________________

Clinical Laboratories

Point of Care

Testing

ACCU-CHEK INFORM II BLOOD GLUCOSE DETERMINATION

I. PURPOSE AND PRINCIPLE

The Accu-Chek Inform II meter is used for Quantitative determination of glucose in

whole blood specimens. The enzyme on the test strip, mutant variant of quinoprotein

glucose dehydrogenase converts the glucose in the blood sample to gluconolactone.

This reaction creates a harmless electrical current that the meter interprets as a glucose

concentration in mg/dL.

The system is calibrated with venous blood containing various glucose concentrations

and is calibrated to deliver plasma-like results. The reference values are obtained using

a validated test method. This test method is referenced to the hexokinase method and

is traceable to an NIST standard.

II. SCOPE

The Accu-Chek Inform II meter is used for monitoring blood glucose levels in hospitals,

ambulatory practices, and home care settings. It is used in both adult, pediatric, neonate

patient populations, however, it’s accuracy and precision in critically ill patients has not

been evaulated. The test is to be used for monitoring glucose levels and should not be

used for diagnosis.

III. PERSONNEL

Intended for use by clinical personnel who have received training and demonstrated

competency in this procedure. In the hospital setting, this includes Clinical Laboratory

Scientists, Registered Nurses, Nurse Practitioners, Physician Assistants, Physicians,

Respiratory Tech. In the ambulatory setting, this includes the aforementioned

personnel as well as Medical Assistants, Licensed Vocational Nurses and other

licensed Technologists.

IV. SPECIMEN REQUIREMENTS AND INTERFERENCES

A. Use capillary whole blood samples obtained from fingerstick. For children under

12 months of age, sample is obtained from heel stick. Fingerstick and heel stick

samples must be tested immediately. Do not use plasma, serum or Cord Blood

samples.

B. Wipe away the first drop of blood with gauze and use the second free-flowing

drop of blood from the fingerstick site for testing.

C. Venous, arterial or neonatal blood sample collected in lithium heparin are also

acceptable. Sample must be tested within 30 minutes of drawing to minimize the

effects of glycolysis.

Rev 1, Ver 2, 9/9/2013

Summary of content (17 pages)

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Director Signature__________________________________ Date___________________ Point of Care Testing Clinical Laboratories ACCU-CHEK INFORM II BLOOD GLUCOSE DETERMINATION I. PURPOSE AND PRINCIPLE The Accu-Chek Inform II meter is used for Quantitative determination of glucose in whole blood specimens. The enzyme on the test strip, mutant variant of quinoprotein glucose dehydrogenase converts the glucose in the blood sample to gluconolactone.
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D. E. V. CALIBRATION VERIFICATION / LINEARITY A. B. VI. Alternate site capillary testing is unacceptable in a hospital setting. Due to the potential for less vascular circulation in alternate sites, a 30 minute lag time may occur in detecting hypoglycemia from alternate site capillary samples. Patients who have peeled fresh fruit or handled other foods that contain glucose may have falsely high glucose levels.
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. 4. 5. Quality Control Solutions a. Store the controls at room temperature at 15-30°C (59 - 86°F). b. Do not refrigerate or freeze. Unopened control solutions remain stable up to their expiration date when stored at room temperature. c. Control vials must be documented with opened date (Month/Day/Year) and initialed when first opened. d. Controls are good for 90 days after opening or until the expiration date printed on the label, whichever comes first.
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B. C. D. 8. When you want to check the performance of the system. Results for Test Strip, Level 1 Low Control and Level 2 High Control Solutions should fall within the acceptable QC ranges. The meter cannot be used for patient testing if it fails any quality control test. The meter will lock out and not permit patient testing. List of Corrective Actions for Failed QC: Note: If QC fails either level 1 or level 2 or both levels, perform Corrective Actions as follow: 1.
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C. D. E. F. Press and release the “barcode” button. The button now appears with a black background during the scan. Hold the meter so that the window of the barcode scanner is approximately 4 – 8 inches above the barcode you wish to read. The meter beeps once the barcode has been read successfully. Operator ID may also be entered manually by handentering your own Employee ID number. From the Main Menu screen, touch Control Test.
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R. S. T. U. V. W. X. X. ----------- For custom comment, press icon to enter other or additional pertinent customized comment(s), not listed in the pre-programmed comments. Once you have selected and/or entered the desired comment(s), Press [√] to return to the Results Screen. Press [√] again to confirm the result and send the result from the meter wirelessly. Remove the strip and discard in a biohazard waste container. Repeat steps E through U to run the second level of control.
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8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. Hold the meter so that the window of the barcode scanner is approximately 4 – 8 inches above the barcode on the patient’s ID band. The meter beeps once the barcode has been read successfully. Make sure to scan the whole barcode length and not cut-off. Patient ID may also be entered manually, by hand-entering the patient’s medical record number using the touch keypad on the display screen. Confirm patient’s ID and/or Name is correct.
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c. d. Notified MD/NP Lab Draw e. 21. For custom comment, press icon to enter other or additional pertinent customized comment(s), not listed in the preprogrammed comments. If a test strip is bad or if the patient result is between 0-10 mg/dL, an error code will be displayed. Repeat test and follow POCT and Unit policy. Strip Defect Error Extremely Low Blood Glucose Sample Below the meter’s reading range Or a Bad Strip a. b. 22. Important: “Strip Defect Error” can be caused by a: 1.
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C. D. E. F. G. In case of a malfunction of the wireless transmission, there is a base unit wired to the network to download the meters on each nursing unit and clinic. When the meter is docked in its downloader, it will get charged at the same time. Record blood glucose results in the patient’s medical record chart, per protocol in your department. Sites utilizing the patient identification function will download patient results to Electronic Medical Record (EMR) after patient testing.
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D. E. F. G. Do not allow excess moisture to seep into the meter by squeezing off excess cleaning solution from the pre-moistened cleaning cloth before cleaning the surface of the meter and the base unit. If you suspect that moisture may have entered the strip port, perform glucose testing. (If solution is allowed to collect in any meter opening including test strip port, severe damage to the system can occur).
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XVII. RECORDS MAINTENANCE A. Individual patient results are documented in the patient’s medical record, and also downloaded to the Electronic Medical Record (EMR). B. Quality Control monthly reports are maintained and kept in the POCT Clinical Laboratory for at least 3 years. C. Documentation of training and competency are kept in each staff member’s personnel file. XVIII. RETRIEVAL OF STORED RESULT DURING NETWORK DOWNTIME A. From the Main Menu, press Review Results. B.
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XX. TROUBLESHOOTING A. On Screen Messages 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.
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Display/Sympto m/ERROR CODE Meter displays “QC Due: Immediately” Test Result: “LO/HI” or “RR LO/RR HI” POSSIBLE SOLUTION Meter displays (QC) “FAIL” or “Out of Range” 1. QC result is Outside QC Range or previous QC result failed. 2. Refer to List of Corrective Action(s) for Failed QC on page 4 Battery Low Battery Critically Low Charge the battery by placing the meter in the base unit. 1. Charge the battery by placing the meter in the base unit. 2.
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C. Meter Reset Procedure 1. Place the meter face down on a level surface. 2. Press the reset button in the middle of the battery 3. 4. pack using a tool such as a screwdriver or a paper clip. Turn over the meter. a. The Roche logo is displayed. b. If the Roche logo does not appear within 60 seconds, place the meter on a base unit for a minimum of 15 minutes to recharge the battery. c.
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F. Troubleshooting Contact Information: 1. For BROKEN METER, LOANERS, Base Unit, & Meter Battery: a. Contact CLINICAL ENGINEERING: 1. 2. 3. Parnassus campus & General Number: Room M-60 (415-3531727) Mt. Zion campus: Room MTZ B007 (415-885-7642 / 415-3531727) Mission Bay campus: Room 170 MB Ortho Institute (415-514-6085) 2. 3. 4. For Broken or Replacement of Carrying Case, contact Roche Customer Service at 1-800-440-3638 For RESULT TRANSMISSION ISSUES / NETWORK CONNECTIVITY PROBLEM: a.
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XXI. REFERENCES A. B. C. D. E. F. G. H. I. J. K. L. Internal Policy Accu-Chek Inform II Blood Glucose Monitoring System Operator’s Manual 2013 ACCU-CHEK Inform II Blood Glucose Monitoring System Operator’s Manual for Healthcare Professionals 2012 Accu-Chek Inform II Quick Reference Guide for Healthcare Professionals Accu-Chek Inform II Glucose Control Solutions Product Insert 2012 Accu-Chek Inform II Test Strips Product Insert 2013 at http://www.accu-chek.
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Signature Manifest Document Number: SOP-0478 Title: Accu-Chek Inform II Procedure Revision: 1 All dates and times are in Pacific Standard Time.