Beaufort Memorial Hospital

Beaufort Memorial Hospital

After completing the form, it must be

turned into a member of the Beaufort

Memorial Hospital Education

Department.

This can be done in person or by

faxing the document to:

(843) 522-5928

Beaufort Memorial Hospital

All students must print copies of the

student documentation forms and

bring them to the clinical site.

After completing your documentation,

the 4-page form must be placed into

the patient’s chart under the nursing

tab.

Beaufort Memorial Hospital

The Scavenger Hunt must be

completed on the first orientation day

of each clinical rotation.

After completing the form, it must be

turned into a member of the Beaufort

Memorial Hospital Education

Department.

This can be done in person or by

faxing the document to:

(843) 522-5928

Beaufort Memorial Hospital

All students must print and complete

the following module and test.

After completing the test, it must be

turned into a member of the Beaufort

Memorial Hospital Education

Department.

This can be done in person or by

faxing the document to:

(843) 522-5928

BEAUFORT MEMORIAL HOSPITAL

BEDSIDE GLUCOSE MONITORING

ACCU-CHEK INFORM SYSTEM

I. PRINCIPLE

It shall be the policy of Beaufort Memorial Hospital to develop clinical guidelines, concerning blood glucose monitoring.

To establish safe, accurate bedside blood glucose results using capillary, venous, arterial and neonatal samples to be used in clinical decision making for effective patient care.

II. COMPETENCY TRAINING

All new nursing employees, RN’s, LPN’s, CNA, and ER and OB Technicians and Nurse Interns will receive initial training in nursing orientation. Demonstration, and return demonstration for Quality Control Testing, Patient Testing and monitor operation will be accomplished during unit orientation by a preceptor. The 90-day skill checklist will monitor verification of competency.

Annual re-credentialing will be done for all nursing staff . Methods to access current competency will include the following:

Monitor each user’s quality control performance

Inform System Knowledge Test

Retraining will be instituted as necessary for specific units or specific individuals to assure compliance.

III. REAGENTS AND EQUIPMENT

A. Accu-Chek Comfort Curve Test Strips – Strips should be stored at room temperature. They are stable until the expiration dated on the vial. The vial cap should be replaced as soon as a test strip is removed. Exposure to moisture may cause an erroneous reading. Upon opening a vial of test strips note the inside of the vial cap, this area should not be discolored. If a discoloration is present, discard the vial.

B. Accu-Chek Comfort Curve Glucose Control Solutions – Control solutions should be stored at room temperature. Control solutions are stable for 3 months once opened. Unopened vials are good until the expiration date on the box. NOTE: Control solutions must be dated once opened.

C. Accu-Chek Linearity Solutions- Linearity Solutions should be stored at room temperature. Solutions are good for 3 months once opened.

D. Accu-Chek Inform System

E. Disposable lancet

F. Cotton/Gauze

G. Alcohol pad

H. Gloves

III. SPECIMENS

Capillary, venous, neonatal (including cord blood), and arterial whole blood specimens may be used for testing.

A. The capillary sample must be tested immediately after collection.

B. Blood glucose determinations using venous and arterial blood specimens should be performed within 30 minutes of specimen collection to avoid glycolysis. Mix samples thoroughly.

C. For best results with arterial and venous blood, the following anticoagulants/preservatives are recommended: Heparin and EDTA.

D. Sufficient sample size is required to ensure accurate results.

IV. PATIENT PREPARATION

A. The purpose of the test and the steps of the procedure will be explained to the patient prior to performing the test.

B. Universal precautions must be observed and disposable gloves must be worn while performing the test.

C. If the patient is able, the patient should wash his/her hands prior to testing with capillary samples taken from the fingertip.

D. Fresh capillary whole blood samples should be taken from the side of the fingertip or heel (neonates).

V. PROCEDURE

A. The following items should be gathered and taken to the patient’s bedside:

1. Accu-Chek Inform System

2. Accu-Chek Comfort Curve test strips

3. Single-use, disposable lancet

4. Alcohol swab

5. Cotton ball, tissue, or gauze for wiping finger after stick

6. Disposable gloves

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

C. Wash your hands and put on disposable gloves prior to testing.

D. Using the Accu-Chek Inform System, Press the ON button.

E. Enter (or scan) your operator ID. Press the forward arrow button.

F. Select Patient Test. If Quality Control is required, the Inform system will prompt the user to run QC before it will allow Patient testing to occur. To process QC, refer to the Quality Control section of this procedure.

G. Enter (or scan) the patient ID. Press the forward arrow button.

H. Scan to verify the code number on the test strip vial corresponds to the code number in the Accu-Chek Inform System.

a. If the code numbers match the Inform meter will allow the user to continue by asking the user to insert test strip.

b. If the code numbers do remove the code key and replace it with a new one. Each vial of test strips come with a matching code key. The user must obtain a new vial of test strips and new code key and rescan the vial to continue.not match the Inform meter will prompt the user to

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

Take only one test strip out of the vial at one time. Strips should not be out of the container longer than 3 minutes.

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

Note: Insert test strip BEFORE dosing.

K. When the flashing drop icon appears on the meter display, obtain a blood sample. You may use a whole blood capillary, venous, arterial or neonatal (including cord) blood sample.

L. Using the Accu-Chek Comfort Curve test strip, touch and hold drop of blood to the curved edge of the yellow target area. The blood will be drawn into the test strip automatically. An audible beep will be noted. This lets the user know that the meter has received the blood drop, however, it does not mean that enough blood was delivered. Make certain that the window is full and no yellow is showing. An under-filled window will deliver a false result.

M. An hourglass will appear on the display while waiting for the result. If the result is a Critical Value the Inform System will require a comment code to be entered. At that time, it is appropriate to repeat the test and request a lab draw if the repeat test is still critical.

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

O. Remove the test strip from the meter and discard it according to the hospital’s infection control policy.

P. Press the power OFF button to turn the Accu-Chek Inform System off.

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

R. Document the blood glucose result in the Medication Administration Record or Sliding Scale Flow sheet.

VI. PROCEDURE GUIDELINES

A. If HI is displayed, the blood glucose result may be higher than the reading range of the meter. Refer to the test strip package insert for more information. If this contradicts the patient’s condition, perform a quality control check with glucose control solution and a new test strip. If the control result is within the acceptable range, review proper testing procedure and repeat the blood glucose test with a new strip. If HI still appears on the patient test, request a STAT lab draw to confirm the result. If the control result is not within acceptable range, refer to the Accu-Check Inform System Operator’s Manual before proceeding with patient testing.

B. If the error message “testing error-133 A glucose overflow error has occurred, type 71” appears on the display, the blood glucose result may be extremely high and above the meter’s reading range. If this contradicts the patient’s condition, perform a quality control check with glucose control solution and a new test strip. If the control result is within the acceptable range, review proper testing procedure and repeat the blood glucose test with a new test strip. If the error still appears on the patient test, follow your facility’s policy. If the control result is not within the acceptable range, refer to the Accu-Chek Inform System Operator’s Manual before proceeding with patient testing.

C. If LO is displayed, the blood glucose result may be lower than the reading range of the meter. Refer to the test strip package insert for more information. If this contradicts the patient’s condition, perform a quality control check with glucose control solution and a new test strip. If the control result is within the acceptable range, review proper testing procedure and repeat the blood glucose test with a new test strip. If LO still appears on the patient test, request a STAT lab draw to confirm the result. If the control result is not within the acceptable range, refer to the Accu-Chek Inform System Operator’s Manual before proceeding with patient testing.

D. If a Strip Defect error message appears on the display, the test strip may be damaged or the test was not performed correctly. The test strip should be inserted into the meter prior to applying blood to the test strip. If this display appears before blood is placed on the strip, remove the test strip and reinsert. If the error display remains, repeat the test with a new strip.

E. If the meter displays “Error 88-Bad Dose,” there is an incorrect amount of blood on the strip. A second drop of blood may be applied to the test strip within 15 seconds of the first drop. If more than 15 seconds have passed, the test result may be erroneous and you should discard the test strip and repeat the test.

F. If the temperature warning message appears on the display, the temperature is above or below the operating range of the test strips. Move to a testing area that is between 57° and 104° F (14° and 40° C) and wait five minutes before repeating the test. Do not artificially heat or cool the meter.

VII. EXPECTED VALUES

A. The normal value range for neonatal blood glucose is 40-110 mg/dL.

B. The normal fasting blood glucose range for a non-diabetic adult is 70-110 mg/dL.

VIII. CRITICAL VALUES

A. The critical value for neonatal blood glucose is less than 30 mg/dL. Values reading between 30 mg/dL and 40 mg/dL require a feeding.

B. The critical value for adult blood glucose is less than 40 mg/dL and greater than 400 mg/dL.

C. ALL critical values require a lab draw to confirm the results.

IX. QUALITY CONTROL TESTING

A. Quality control testing is required by regulatory agencies to ensure proper instrument function and quality patient results. Guidelines for quality control are set in keeping with good laboratory practices.

B. Quality control records will be retained for a minimum of two years. Control tests are performed each time a new vial of test strips is opened, if the Inform system has been dropped, and at least every 24 hours. This time interval is set in the Inform system to warn the user when QC is due.

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

2. If a quality control test result falls outside of the acceptable control range, the Troubleshooting section of the Accu-Chek Inform Operator’s Manual is referenced, if needed, and the problem must be corrected before proceeding with patient testing.

3. Any quality control result that falls outside of the acceptable control range, must be saved with a corrective action to restore that result to acceptable range.

4. In areas where the Accu-Chek Inform System is not being used daily, quality control will be performed when patient testing occurs.

5. Internal proficiency testing to verify meter accuracy and operator competency will be performed on a quarterly basis.

6. Glucose control solutions must be stored at room temperature. Do not freeze. Glucose control solutions are stable for three months after opening or until the expiration date, whichever comes first. The date the vial is opened should be written on the vial label.

7. Any outdated glucose control solutions will be discarded.

8. The test strip lot number and the acceptable glucose control ranges are found on the label of each vial of test strips. This information must be recorded according to facility policy.

9. Test strips must be stored at room temperature. Do not refrigerate or freeze. Test strips are stable until the expiration date. Test strips must be stored in the same capped vial in which they were packaged, and the vial cap must be immediately replaced after removal of a test strip.

C. Procedure for Processing Quality Control

1. The following equipment is needed for quality control testing:

a. Accu-Chek Inform System

b. Accu-Chek Comfort Curve test strips

c. Accu-Chek Comfort Curve Glucose Control Solutions: 1) Level 1 (LO) and

2) Level 2 (HIGH)

2. Put on disposable gloves.

3. Press power ON button.

4. Enter (or scan) your operator ID, then press the forward arrow button.

5. Select Control Test.

6. Select the desired control level: Level 1, Level 2.

7. Scan the control vial to verify the lot number of control solution displayed on the Accu-Chek Inform System.

8. Scan the test strip vial to verify that the strip code number on the test strip vial matches the code number on the Accu-Chek Inform System.

a. If the code numbers match the Inform meter will allow the user to continue by asking the user to insert test strip.

b. If the code numbers do not match the Inform meter will prompt the user to remove the code key and replace it with a new one. Each vial of test strips come with a matching code key. The user must obtain a new vial of test strips and new code key and rescan the vial to continue to step 9.

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

Test strips should not be out of the vial for longer than 3 minutes.

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

Note: Insert test strip BEFORE dosing.

11. Using the Accu-Chek Comfort Curve test strip:

a. Touch and hold drop of glucose control solution to the curved edge of the yellow target area.

b. The glucose control solution is drawn into the test strip automatically. An audible beep will be noted. This lets the user know that the meter has received the blood drop, however, it does not mean that enough blood was delivered. Make certain that the window is full and no yellow is showing. An under-filled window will deliver a false result.

12. An hourglass will be displayed on the Accu-Chek Inform meter while waiting for the result.

13. Enter the appropriate comment(s), if needed. Then press the forward arrow button to record the test and to test the next level of control (if other levels are required) or to proceed to patient testing.

14. Remove the used test strip(s) and disposable gloves and discard them according to the hospital’s infection control policy.

15. The results will automatically be recorded.

16. Quality Control records are maintained by the Point of Care Coordinator.

X. LINEARITY TESTING

A. Linearity tests are performed by the Point of Care Coordinator or designee.

B. Linearity is required before a blood glucose meter is placed into service and with each new lot of test strips. This process occurs approximately every 6 months.

C. Linearity results are reviewed and approved by the Medical Director of the Laboratory.

D. Linearity records are retained for two years.

XI. STORAGE/MAINTENANCE OF THE ACCU-CHEK INFORM SYSTEM

A. The Accu-Chek Inform System is handled with care. Sudden shocks caused by dropping or rough treatment may affect performance. If the Accu-Chek Inform System is dropped, performance is verified by quality control testing.

B. The Accu-Chek Inform System is stored away from direct sunlight and extreme temperatures.

C. Cleaning and maintenance of the Accu-Chek Inform System is performed weekly or whenever the unit is soiled. Unit should be wiped down using a Sani-Cloth everyday with the scheduled daily control testing. Do not allow liquid from the Sani-Cloth to enter the unit.

D. Disposable gloves must be worn when performing preventive maintenance and cleaning on the Accu-Chek Inform System.

E. If personnel are unable to correct a problem with the Accu-Chek Inform System, it is removed from service and sent to the Point of Care Coordinator in the Laboratory for repair/replacement. The Accu-Chek Inform System must be cleaned and disinfected before it is sent out for repair or replacement.

F. Use only the battery pack available from Roche Diagnostics (Cat. No. 3034844) in the Accu-Chek Inform System. Using any other type of battery pack may damage the system.

G. If the Accu-Chek Inform System is to be stored for a long period of time, the battery is removed to avoid leakage or damage.

XII. LIMITATIONS OF THE METHOD

Test strips give dependable test results if the following limitations are understood:

A. Use only Accu-Chek Comfort Curve test strips for testing capillary, venous, neonatal (including cord), and arterial whole blood samples.

B. Blood glucose determinations using venous and arterial blood specimens should be performed within 30 minutes of specimen collection to avoid glycolysis. Avoid air bubbles if dosing with pipettes. Air bubbles may cause erroneous results.

C. For best results with arterial and venous blood, the following anticoagulants/ preservatives are recommended: heparin and EDTA.

D. Serum separator tubes and red-topped tubes are acceptable if blood is used immediately before the clotting process begins.

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

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

G. Caution is advised in the interpretation of neonate glucose values below 50 mg/dL. Follow the recommendations for follow-up care that have been set by for critical glucose values in neonates.

H. Do not use during xylose absorption testing.

I. No effect was found at 20% to 65% hematocrit and glucose concentrations up to 200 mg/dL.

J. At glucose concentrations above 200 mg/dL, low hematocrits (below 20%) may cause elevated results and high hematocrits (above 55%) may cause reduced results versus a whole blood reference.

K. System measurement range is 10-600 mg/dL.

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

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

Compound Limitation

Galactose >10 mg/dL

Maltose >16 mg/dL

Bilirubin (unconjugated) >20 mg/dL

Lipemic Samples >5000 mg/dL

Acetaminophen >8 mg/dL

Uric Acid:

Hypoglycemic range >10 mg/dL

Euglycemic range >12 mg/dL

Hypergylcemic range >16 mg/dL

N. In situations of decreased peripheral blood flow, fingerstick blood testing may not be appropriate as it may not reflect the true physiological state. Examples would include but are not limited to: Severe dehydration caused by diabetic ketoacidosis or the hyperglycemic hyperosmolar nonketotic state, hypotension, shock, or peripheral vascular disease.

O. Refer to the test strip package insert for updated information.

XIII. REFERENCES

Mor, Juan-R. and Guarnaccia, Rocco: Assay of Glucose Using an Electrochemical Enzymatic Sensor, Analytical Biochemistry, 79:319-328 (1977).

D’Costa, E.J., Higgins, I.J., et al., Quinoprotein Glucose Dehydrogenase and its Application in an Amperometric Glucose Sensor, Biosensors, 2:71-87 (1986).

Hauge, J.G., Glucose Dehydrogenase of Bacterium Anitratum: An Enzyme with a Novel Prosthetic Group, Journal of Biological Chemistry, 239:3630-3639 (1964).

Tietz, N.W., Textbook of Clinical Chemistry, p. 2190 (1994).

American Diabetes Association Position Statement, Diabetes Care, Vol. 19 (suppl. 1), p. S4 (1996).

Atkin, S.H.; Dasmahapatra, A.; Jaker, M.A.; Chorost, M.I.; Reddy, S., Fingerstick Glucose Determination in Shock, Annals of Internal Medicine, 114:1020-1024 (1991).

Sandler, M.; Low-Beer, T., Misleading Capillary Glucose Measurements, Practical Diabetes, 7:210 (1990).

Wickham, N.W.R.; Achar, K.N.; Cove, D.H., Unreliability of Capillary Blood Glucose in Peripheral Vascular Disease, Practical Diabetes, 3:100 (1986).

Beaufort Memorial Hospital

All students must print and sign the

following documents.

After completion, they must be

turned into a member of the Beaufort

Memorial Hospital Education

Department.

This can be done in person or by

faxing the document to:

(843) 522-5928