Accu-Chek Inform II Competency Manual del operador descargar pdf

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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

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Pagina 1 - Testing

1 of 16Director Signature__________________________________ Date___________________Clinical LaboratoriesPoint of Care Testing ACCU-CHEK INFORM II

Pagina 2

10 of 16D. Do not allow excess moisture to seep into the meter by squeezing off excess cleaning solution from the pre-moistened cleaning cloth before

Pagina 3

11 of 16XVII. RECORDS MAINTENANCEA. Individual patient results are documented in the patient’s medical record, and also downloaded to the Electronic M

Pagina 4 - Control is due. Required

12 of 16XX. TROUBLESHOOTINGA. On Screen MessagesB. Error CodesAll error messages displayed by the system have a letter identifying the message type, a

Pagina 5 - “Control lot not found

13 of 16Display/Symptom/ERROR CODEPOSSIBLE SOLUTIONMeter displays “QC Due: Immediately”Run controls immediately.Patient testing cannot proceed until c

Pagina 6

14 of 16C. Meter Reset Procedure1.Place the meter face down on a level surface.2.Press the reset button in the middle of the battery pack using a tool

Pagina 7

15 of 16F. Troubleshooting Contact Information:1. For BROKEN METER, LOANERS, Base Unit, & Meter Battery: a. Contact CLINICAL ENGINEERING:1. Parna

Pagina 8

16 of 16XXI. REFERENCESA. Internal PolicyB. Accu-Chek Inform II Blood Glucose Monitoring System Operator’s Manual 2013C. ACCU-CHEK Inform II Blood Glu

Pagina 9

Signature ManifestDocument Number:SOP-0478Revision:1Title: Accu-Chek Inform II ProcedureAll dates and times are in Pacific Standard Time.Accu-Chek Inf

Pagina 10 - Rev 1, Ver 2, 9/9/2013

2 of 16D. Alternate site capillary testing is unacceptable in a hospital setting. Due to the potential for less vascular circulation in alternate sit

Pagina 11

3 of 163. Quality Control Solutionsa. Store the controls at room temperature at 15-30°C (59 - 86°F).b. Do not refrigerate or freeze. Unopened control

Pagina 12

4 of 168. When you want to check the performance of the system.B. Results for Test Strip, Level 1 Low Control and Level 2 High Control Solutions shoul

Pagina 13

5 of 16C. Press and release the “barcode” button. The button now appears with a black background during the scan.D. Hold the meter so that the window

Pagina 14

6 of 16R. For custom comment, press icon to enter other or additional pertinent customized comment(s), not listed in the pre-programmed co

Pagina 15

7 of 16Hold 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 b

Pagina 16 - REFERENCES

8 of 16c. Notified MD/NP d. Lab Drawe. For custom comment, press icon to enter other or additional pertinent customized comment(s), not li

Pagina 17

9 of 16C. 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

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