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Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08; 11/08
Page 1 of 15
WHOLE BLOOD GLUCOSE
ACCU-CHEK INFORM SYSTEM
I.
SCOPE
This procedure provides written instructions to ensure safe and accurate glucose
measurement using the waived Accu-Chek Inform System. It is intended to be used by all
trained and competent testing personnel, including Nursing, Pathology, Emergency Services,
Women’s & Infant’s Specialty Health, Surgery Services, Psychiatric Services, and COPC
personnel. This test may be performed under practitioner order or per established protocol.
Patient self-testing glucose meters are not subject to the same procedures as outlined below,
and may not be used for screening or treatment purposes within Parkland Health & Hospital
System.
II.
PRINCIPLE
The determination of glucose using the Accu-Chek Comfort Curve Test Strips is based on the
enzyme glucose dehydrogenase, converting the glucose in the blood sample to gluconolactone.
This reaction liberates an electron that reacts with a coenzyme electron acceptor, the oxidized
form of the mediator hexacyanoferrate (III), forming the reduced form of the mediator,
hexacyanoferrate (II). The Comfort Curve Test Strip employs the electrochemical principle of
biamperometry. The meter applies a voltage between two identical electrodes, which causes
the reduced mediator formed during the incubation period to be reconverted to an oxidized
mediator. This generates a small current that is read by the meter. The Accu-Chek Inform
System is calibrated to capillary whole blood using the glucose hexokinase reference method.
The Inform blood glucose monitoring performed by Parkland Health & Hospital System
personnel is used to immediately determine blood glucose levels at the patient point of care
area. This test is to be used for screening or treatment purposes.
III.
SPECIMEN
This test requires whole blood, including capillary, venous, and arterial specimen types.
Each patient tested must be identified and collected per institutional protocol.
Capillary blood must be tested immediately after collection.
Evacuated tubes collected by venipuncture and arterial draws must be labeled properly.
Well-mixed EDTA or heparin anticoagulant tubes are required for non-capillary specimens.
Specimens must be tested within 30 minutes of specimen collection to avoid glycolysis. Mix
samples thoroughly.
The Accu-Chek Comfort Curve Test Strips fill by capillary action, drawing 9 µL of whole
blood onto the yellow test strip window.
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Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Page 2 of 15
Capillary collection procedure:
Step
Action
1
Universal precautions must be followed when collecting and handling blood
specimens.
2
Fresh capillary whole blood samples are to be taken from the fingertip, earlobe,
or from a heelstick when the patient is a neonate. Allow the patient’s arm to
hang lower the their heart to increase circulation to the fingertip, if possible.
3
Cleanse the puncture site with an alcohol swab. Allow the area to air dry.
NOTE: The presence of alcohol can result in an error code and/ or inaccurate
results.
4
Obtain the blood sample using a safety collection device.
NOTE: Strong repetitive pressure (milking) should not be applied; it may cause
hemolysis or contamination of the specimen with tissue fluid. The procedure for
capillary collection is found in Nursing Policies and Procedures under Pathology
(Specimen Collection) P-0172.
5
Blood glucose determinations using venous and arterial blood specimens should
be performed within 30 minutes of specimen collection to avoid glycolysis. Mix
samples thoroughly. The procedures are also under Pathology (Specimen
Collection) P-0171 and NSG 26-01.
6
If arterial blood is being collected from a line, assure that the line has been
cleared before collecting the sample.
The patient does not require any specific preparation before collection of a random glucose.
For a fasting blood glucose test, the patient must be educated in dietary restrictions.
Venipuncture specimens may not be collected above an intravenous line.
Specimen Rejection
The following specimens are considered unacceptable and must be rejected: patient samples
identified improperly, serum samples with or without gel, samples collected in anticoagulants
other than EDTA or heparin, capillary samples that are not tested immediately, EDTA or
heparin samples that are >30 minutes old, hemolyzed or clotted samples, specimens of
questionable integrity (improper finger stick collection), or QNS specimens. Blood drawn
during xylose absorption testing must not be used, as well as blood drawn from a patient who
is receiving products containing xylose, maltose, and/or galactose. The appropriate action is
to recollect specimen and retest.
IV.
EQUIPMENT
•
•
Accu-Chek Inform System (operational at 14-40°C and <85% relative humidity)
Important Safety Warning: DO NOT look directly into the Class II laser aperture
(barcode scanner) or its specular reflections. This rule applies regardless of any
protective eyewear worn, including glasses, safety glasses/goggles, and sunglasses. Take
caution to avoid flashing laser at another person while scanning barcodes on IDs,
controls, strips, and/or patients.
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
•
•
•
•
•
•
•
V.
Page 3 of 15
Accu-Chek Comfort Curve Test Strips
Accu-Chek Inform Code Key (provided in each vial of test strips)
Accu-Chek Comfort Curve Glucose low and high level control solutions (store at <32°C,
but do not freeze) – MRD# 23609
Base Unit for recharging battery and downloading / uploading
Gloves, alcohol, cotton ball/gauze, bandage
Approved safety collection devices
Use only the fingertip to make selections on the touchscreen.
REAGENTS
Accu-Chek Comfort Curve Test Strips are available in MRD as #23608. A Code Key is
provided with each vial of test strips. Refer to MSDS sheets for specific information
regarding reagent hazards.
Once opened, continue to store at <32°C in original vial capped at all times. Do not freeze.
Label container with open or in-use date. Replace vial cap immediately after removal of a
test strip. If loose drying beads are detected in the vial itself, do not use the vial of Comfort
Curve Test Strips. Return to MRD for a satisfactory replacement of the product.
Test Strips function at temperatures between 14-40°C and relative humidity <85%. The
discard date is the manufacturer’s printed expiration date on vial. Do not use after
manufacturer’s printed expiration date.
VI.
CALIBRATION
The Accu-Chek Inform System must be calibrated each time a new lot number of test strips
is opened. The test strip code displayed by the glucose meter must match the code of the test
strips in use. If not, the meter must be recoded (recalibrated) and the new code information
must be entered into the Inform System. In order to assure consistent appropriate
calibration, follow the steps below to change the Code Key with each new vial of test strips:
Step
1
Action
Remove the Code Key from the Accu-Chek Comfort Curve Test Strip vial.
2
Make sure the meter is turned off before removing the old Code Key from the
Inform meter.
3
With the meter turned screen down, slide the new Code Key (slots facing towards
the meter) into the Code Key slot with the printed side facing up.
4
Power ON the meter and leave the Code Key in the meter until the next vial is put
into use.
5
Perform Quality Control as outlined in Section VII.
6
Repeat steps 1-5 of this procedure each and every time a new vial of test strips is
put into use.
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Page 4 of 15
VII. QUALITY CONTROL
Accu-Chek Comfort Curve Glucose quality control solutions (2 levels) are available in MRD
as number 23609. Testing condition for controls is 1-32°C. Record discard date (3 months
after open date) on the control bottles, along with initials. Do not use after discard date
(opened expiration date) or manufacturer’s expiration date – whichever comes first.
Quality control solutions must be analyzed at the following times:
•
•
•
•
•
•
Once every 24 hours at a minimum.
When opening a new vial of test strips and before placing the strips into use
(whether a current or new lot number of strips – using new Code Key as described
above in the Calibration procedure in Section VI).
When the vial of test strips has been left open.
Whenever the patient’s result contradicts the patient’s condition.
Whenever an operator wants to check the performance of the meter and test strips
(general troubleshooting).
If the Inform System has been dropped or damaged.
NOTE: If the controls are tested for some reason other than routine QC lockout, please
document the reason by using the appropriate comment found listed below.
Step
1
Action
Press the power ON button and scan the operator ID.
Alternatively, enter the ID using only the fingertip; press the forward arrow button.
2
Select Control Test and then scan the control solution vial barcode to be tested.
Alternatively, select a control level and verify the control solution lot number by
pressing YES or NO.
3a
If the meter recognizes the control solution lot number, or YES is selected in Step 2,
proceed to 4.
3b
If the meter does not recognize the control solution lot number or NO is selected in
Step 2), meter will ask for user to scan the new bottle of control solution. Select
YES to confirm that the new lot number is in use. Proceed with 4.
4
Scan the test strip vial barcode.
Alternatively, verify the strip code information by viewing the strip lot number and
confirming the same strip lot number on the test strip vial by pressing YES or NO.
5a
If the barcode is scanned, or if YES is selected, the flashing strip icon appears on the
meter display with a moving arrow. Remove one strip from the vial and insert strip
into strip port with the silver electrode facing up. A beep will signify contact.
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Page 5 of 15
Step
Action
5b
If the barcode scan does not accept the lot number, or if NO is selected, replace old
Code Key with the new Code Key packaged in the strip vial by following the
Calibration procedure in section VI.
If the new strip lot is defined in the meter, confirm the use of the strip code by
pressing YES and continue testing.
If the strip lot is undefined, a message will appear asking if the strip lot should be
added. Press YES to update the meter with the new code key information. If the
strip lot has not previously been entered into the meter, a message will appear asking
if the strip lot should be added. Press YES and then enter the expiration date.
The next screen will ask the user to verify that the control ranges assigned to this lot
are correct. Press ACCEPT to verify the control ranges. The Verify Strip Lot
screen will display again. Press YES to verify the strip lot number.
6
Recap the strip vial immediately and use the test strip within 3 minutes.
7
Touch and hold a drop of the control solution to the curved edge of the yellow target
area. The drop will be drawn into the strip via capillary action. Remember that the
Comfort Curve test strip is a side-dosing strip. If the yellow target area is not
covered completely by the colored control solution, additional solution may be
added within 15 seconds.
NOTE: In the event that a meter beeps when the control solution touches the test
strip, do not assume that this indicates adequate sample volume. Visually confirm
that the yellow target area is covered with control solution.
8
A control result message will appear in 26 seconds as either PASS or FAIL. If the
control passes, press the forward arrow button to “record” the test.
9
Remove the test strip and discard according to infection control policy.
10
Select the next level of control and repeat the above steps 2-8. Selecting Control
Test is not necessary on subsequent QC tests. If the meter powers, down, it will be
necessary to start with step 1.
11
If a control test fails, select the flashing comment ‘bar’ on the screen and enter the
appropriate comment from the following list:
•
Repeat Test
•
Wrong QC Level
•
Replaced Test Strips
•
Replaced Controls
12
Any corrective action must be recorded with a comment in the Inform System. The
meter can hold 3 codes, plus an additional 4th code if manually entered (free text).
When finished entering comment(s), repeat the control that failed.
13
Once both levels of control have passed, patient testing can be performed.
If QC is outside published ranges, this may be indicative of one or more problems, including
but not limited to product deterioration, incorrect environmental conditions (for example,
overheating or freezing during shipping or storage), Comfort Curve Test Strip problems,
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Page 6 of 15
instrument malfunction (for example, calibration or coding issues or damaged electronics), or
procedural problems. Both Level 1 and Level 2 controls must fall within the acceptable
ranges. If either or both of the quality control results are outside the acceptable ranges,
repeat level(s) out of range. If control(s) is still out of range, perform the following
troubleshooting steps until acceptable results are obtained:
•
•
•
•
•
•
Do not report patient results
Review the test policy and procedure.
Check the expiration dates on the QC solutions and strips (replace if expired).
Open new bottles of QC solution and repeat level that is out of range.
Open a new vial of test strips and repeat testing.
If still not in range, contact Pathology Point of Care Testing personnel assistance.
VIII. PROCEDURE
For each patient test, the Accu-Chek Inform System stores the test result, operator ID, patient
ID, test strip code information, test time and date, and appropriate comment(s). Only a
certified operator may perform a blood glucose test on the Accu-Chek Inform System.
Step
Action
1
Assemble the required supplies and equipment at the patient’s location. Observe
universal precautions.
2
Press the power ON button and scan the operator ID.
Alternatively, enter the ID using only the fingertip; press the forward arrow button.
3
Select Patient Test and then scan the patient ID.
Alternatively, enter the patient medical record number or some other approved
substitute numbering system that is traceable to the patient in an audit. Press the
forward arrow button.
4
Scan the test strip vial barcode.
Alternatively, verify the strip code information by viewing the strip lot number and
confirming the same strip lot number on the test strip vial. Press YES or NO.
4a
If the barcode is scanned, or if YES is selected, the flashing strip icon appears on the
meter display with a moving arrow. Remove one strip from the vial and insert strip
into strip port with the silver electrode facing up. A beep will signify contact.
4b
Select NO if the code numbers do not correspond. See 5b of Quality Control Section
VII.
5
Recap the strip vial immediately and use the test strip within 3 minutes.
6
After the flashing drop icon appears on the meter display, obtain a whole blood
sample. Touch and hold a drop of blood to the curved edge of the yellow target area.
The drop will be drawn into the strip via capillary action. Remember that the
Comfort Curve strip is a side-dosing strip. If the yellow target area is not completely
covered by the blood sample, addition blood may be added within 15 seconds.
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Step
Page 7 of 15
Action
NOTE: In the event that a meter beeps when the patient blood touches the test
strip, do not assume that this indicates adequate sample volume. Visually
confirm that the yellow target area is covered with blood.
7
A screen with an hourglass is displayed while waiting for the results.
• An audible beep will be heard and the Patient Results will be displayed.
• Press the bar beneath the patient result to view the Adult Normal and Critical
Ranges.
• If the patient result is out of normal or critical range, there will be a warning
message under the result inside this bar. The comment bar will also flash.
8
When applicable, select the comment bar to enter a comment. The meter can hold
3 codes, plus an additional 4th code if manually entered (free text). The
following comments may be used to document or describe action(s) taken
based on patient testing.
•
Repeat Test
•
Provider Notified
•
Nurse Notified
•
Sent to Laboratory
•
Insulin Given
•
Fasting
•
Proficiency Sample
•
Diabetic Monitoring
•
Patient Non Compliant
•
No Action Needed
Press the forward arrow button to continue.
9
Remove the strip and discard according to infection control policy.
10
Document glucose value. The screen will remain active for 10 minutes as long as
results are displayed. Once the meter turns itself off, it may be necessary to see the
result using the Review Result function on the Main Menu.
11
Power off meter and return the Inform glucose meter to its docking station.
Because the linearity of the Accu-Chek Inform System meter has a Parkland-established
range of 40 to 500 mg/dL, any numerical value below 40 mg/dL (20-39 mg/dL) must be
documented as “<40 mg/dL” on the patient’s medical record, flowsheet, or Point of Care
Test Report form. Any numerical value above 500 mg/dL (501 or greater mg/dL) must be
documented as “>500 mg/dL” on the patient’s medical record or Point of Care Test Report
form.
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Page 8 of 15
Documentation of Error Codes associated with low and high patient glucose values:
(1) If the "LO or CR LO or RR LO" display appears, the blood glucose level is either
below 40 mg/dL or the strip has not been prepared or inserted correctly.
• If the "LO or CR LO or RR LO" display is obtained upon repeat analysis, obtain a
blood sample for laboratory confirmation if requested by practitioner. Due to the
established linearity mentioned above, report out this test as “<40 mg/dL.”
(2)
IX.
If "HI or CR HI or RR HI" appears on display, the blood glucose level is either above
500 mg/dL or the strip has not been prepared correctly.
• If the "HI or CR HI or RR HI" display is obtained upon repeat analysis, obtain a
blood sample for laboratory confirmation if requested by practitioner. Due to the
established linearity mentioned above, report out this test as “>500 mg/dL.”
CALCULATIONS
No calculations are required or recommended.
X.
REFERENCE RANGES
For a neonate (0-2 years of age), the blood glucose range is 40-100 mg/dL.
The fasting blood glucose range for a non-diabetic individual greater than 2 years of age is
65-126 mg/dL.
A random blood glucose range for a non-diabetic individual greater than 2 years of age is 65200 mg/dL.
Critical values:
Neonate
Adult
< 40 mg/dL or > 200 mg/dL
< 40 mg/dL or > 500 mg/dL
Various areas of Parkland Health & Hospital System may have action levels for glucose
which differ from Pathology-established critical values.
XI.
REPORTABLE RANGE
Each Accu-Chek Inform System has its own linearity based on the lot number of test strips
used during instrument linearity setup. However, the Parkland-established linear reportable
range is from 40 mg/dL to 500 mg/dL for adults and 20 mg/dL to 500 mg/dL for NNICU and
NBN patients. If a patient test result falls below or above the reportable range, a blood
sample may be sent to the laboratory for confirmation if requested.
Linearity is determined on each instrument before it is put into use. Linearity is repeated on
a meter if it has been repaired or if it had critical parts replaced. Only Pathology Point of
Care Testing personnel perform linearities for the Inform meters.
NOTE: Do not attempt to dilute whole blood to manually calculate a glucose value
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Page 9 of 15
above the linearity of the analyzer.
XII. RESULT REPORTING
Glucose values are reported in mg/dL. All glucose results for patient care areas are
documented in the patient medical record, the Point of Care Test Report form, the Patient
Flowsheet or Test Log, or entered directly into the LIS. Glucose results from the Accu-Chek
Inform meter must not be written on other instrument printouts or entered into the LIS under
tests intended for other analyzers. Written results must include the patient glucose result and
the operator’s ID#.
NOTE: Each meter will no longer be identified with a Parkland-specific number; all results
will be traceable through the computer download system along with details on the patient,
date, time, specific meter, and testing personnel.
Nursing personnel and other patient care staff performing testing must document abnormal
values with relation to changes from prior glucose values, note responsiveness to therapy if
applicable, and notify practitioner of critical values.
All glucose results generated by laboratory personnel must be entered into LIS. Lab
personnel must document critical values on the Critical Value Log and in the LIS. The
communication of critical values is only to the responsible licensed caregiver representing
the appropriate patient care area. The responsible licensed caregiver receiving the critical
value verbally should write down the value and then read it back verbatim to the lab
personnel. Lab personnel will then document that the read-back has occurred.
XIII. TEST INTERPRETATION
The quantitative glucose determination if indicated as a general fundamental test in acute as
well as elective care. This test is used for assessing the status of a patient in such clinical
situations as diabetes management, and other clinical indications such as detection of glucose
extremes in patients with symptoms of hypoglycemia and severe hyperglycemia, immediate
post-partum care for diabetic mother and infant, glucose determination in coma patient in ER,
and monitoring parental hyperalimentation. Other changes in glucose tolerance are found in
Cushing’s
syndrome,
pheochromocytomas,
primary
aldosteronism,
acromegaly
hyperthyroidism, acute pancreatitis, chronic liver disease, myocardial infarction and salicylate
overdose (in children). The assay of glucose is also used as a part of a general health screen.
The ordering practitioner is responsible for the interpretation of the results based on the
patient’s condition, including peripheral circulation, use of medications, and dietary intake.
XIV. TEST INTERFERENCES/LIMITATIONS
A.
Avoid air bubbles if dosing with a pipette or syringe. Air bubbles may cause falsely low
results.
B.
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
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Page 10 of 15
are not limited to: severe dehydration caused by diabetic ketoacidosis or hyperosmolar
nonketotic state, hypotension, shock, or peripheral vascular disease.
C.
Blood collected during xylose absorption testing may produce false glucose values.
D.
The following compounds, when determined to be in excess of their limitation, may
produce elevated glucose results:
Compound
Limitation
Galactose*
>10 mg/dL
Maltose
>16 mg/dL
Bilirubin (unconjugated)
>20 mg/dL
Lipemic samples
>5,000 mg/dL
Acetaminophen
>8 mg/dL
Uric Acid:
Hypoglycemic range >10 mg/dL
Euglycemic range >12 mg/dL
Hyperglycemic range >16 mg/dL
*No interferences were found with other reducing sugars.
E.
Hematocrit range is 20-65% for glucose measurements less than 200 mg/dL and 20-55%
for glucose measurements greater than 200 mg/dL.
F.
Peritoneal dialysis solutions containing icodextrin cause overestimation of glucose
results.
G.
The following can also cause unusually high or low results:
•
•
•
•
•
•
•
Blood sample size was inadequate to cover yellow window of test strip
Strip was out of vial longer than three minutes before blood sample applied
Strip was used after Use By date
Strip was not stored in vial with cap tightly sealed (or desiccant removed from vial)
Strip vial was stored in extreme temperatures
Code Key number in Accu-Chek meter or hospital system did not match Code Key
number on vial of strips
Proper maintenance and handling procedure for the Inform meter has not been
followed.
H.
Diet and insulin or other diabetic medications affect glucose measurements and care must
be taken when interpreting all patient values.
I.
Meters must not be subjected to sources of heat for more than 10 seconds; otherwise, the
meter must be allowed to return to room temperature (14-40°C) prior to testing:
• Bilirubin light, phototherapy, bed warmers or isolettes
• Other sources of heat that can generate temperatures above 40°C.
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
Page 11 of 15
XV. TROUBLESHOOTING
The following action grids address the most common problems or error messages
encountered with the Accu-Chek Inform System:
Symptom
Meter
display is off
Explanation
•
Touchscreen has powered down to
conserve battery.
•
The battery is running low or is
depleted.
Meter
displays a
line across
the
touchscreen
Touchscreen may be damaged or
defective.
Database
Failure 130
or DB Full
131
Data management system has a
problem.
Code Key
problem
Base Unit
light is not
illuminated
•
Code key may be absent from
meter.
•
Code key may be damaged or
defective.
•
Code Key may be for an expired
lot number
Action
•
Wait 10 seconds and try turning unit
meter on again by pressing power ON
key.
•
Return meter to the base unit as soon as
possible to recharge at least 15 minutes.
Turn on again. May require new battery.
•
Return meter to the base unit as soon as
possible to recharge at least 15 minutes.
[If the battery is new, charge for at least 3
hours.]
•
Perform a control solution to see if line
disappears.
•
Discontinue use of meter.
•
Contact Pathology or Accu-Chek
Customer Care Service Center at number
below.
•
Insert a valid Code Key in order to
perform a test, verifying the replacement
is for the correct lot number of test strips.
•
Insert a replacement Code Key, verifying
the replacement is for the correct lot
number of test strips.
•
Verify that the test strips are not expired.
•
Base Unit may not be plugged in.
•
•
Power system may be
compromised.
Verify the Base Unit is plugged into an
operating power source.
•
•
Base Unit may be defective.
Unplug Base Unit and plug back in. If the
light still does not illuminate, an internal
problem has occurred.
•
Only valid operators are allowed to
perform testing.
•
Contact Pathology in order to get certified
in the system.
Operator ID
is Invalid
The Operator ID entered was not
found in the current list of valid
operators.
Control Lot
Not Found
The meter does not recognize the lot
number of control solutions.
Input control lot number by following Quality
Control procedure Section VII Step 3b.
Strip Lot Not
Found
The meter does not recognize the lot
number of test strips.
If the strip lot number is not recognized,
contact Pathology in order to get the strip lot
number downloaded into the meter.
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08; 11/08
Symptom
Error 83
Error 88
QC Fail or
Out of
Range
Operator
Lockout
164
Invalid
Operator 14
Page 12 of 15
Explanation
The strip may be damaged, used previously,
dosed incorrectly with the incorrect amount of
blood, inserted incorrectly, or the patient’s
blood glucose may be extremely low and
below the system’s reading range (<10
mg/dL).
The amount of the blood sample may be
insufficient.
Action
•
Remove strip and insert strip again if it has
not been previously used.
•
If same code appears, replace with new test
strip and discard used/damaged strip. If the
same code appears the second time, it is
possible that the patient’s blood glucose
may be extremely low and below the
system’s reading range (<10 mg/dL).
•
Perform venipuncture and send to Lab
Central if glucose confirmation desired.
•
Make sure that the yellow reagent square is
covered inside with blood sample.
•
Adding additional blood within 15 seconds
of first application is acceptable practice.
•
If application of more sample is beyond 15
seconds, restart the procedure using a fresh
sample with fresh test strip.
Refer to Quality Control procedure Section VII
Step 3b for QC troubleshooting.
If the problem persists, call the Pathology
Quality Assessment personnel to check “setup”
of the meter (i.e., control ranges may have been
incorrectly entered by the operator), or to
arrange for a replacement Inform.
Warning: Operator is currently locked out from
test performance. See system administrator.
Contact Aziz Lakhani at 214.590.8662 or
Steven Lee at 214.590.5297 in order to be
credentialed in the system. Leave message if
call is before 0730 or after 1600 or if it is the
weekend or a holiday. For off-campus clinics,
please consult with designated Med Tech III.
Operator ID is not valid; ID entered is not on
the valid Operator IDs. See system
administrator.
Contact Aziz Lakhani at 214.590.8662 or
Steven Lee at 214.590.5297 in order to be
credentialed in the system. Leave message if
call is before 0730 or after 1600 or if it is the
weekend or a holiday. For off-campus clinics,
please consult with designated Med Tech III.
If certified operators are unable to correct a problem with the Inform, remove it from service
and notify Pathology Point of Care Testing personnel. Alternatively, contact Accu-Chek
Customer Care Service Center at 1.800.440.3638.
For after-hours meter replacement in the hospital (before 0730 and after 1600 Monday –
Friday, plus weekends), call Pathology Phlebotomy Services at x26687. If the call rolls
over to voicemail, it will provide a pager number for more immediate service.
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Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
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XVI. MAINTENANCE
Clean the Accu-Chek Inform System in between each patient use following the steps below.
DO NOT SPRAY the meter directly with a solution, as this could cause the solution to enter
the case and damage the electronic components. Water may also be used to clean the meter,
but this will not disinfect.
NOTE: Do not use cleaners with polyhexanide, phenol, or prepared solutions or wipes that
contain a mixture of bleach and detergent. Do not use alcohol wipes.
Step
Action
1
Remove the meter from the base unit prior to cleaning.
2
DO NOT clean the meter while performing a patient or control test.
3
Wipe the surface with the Infection Control approved germicidal wipes from
the Materiel Resource Department.
4
Dry the meter thoroughly.
5
Use the same method to clean the base unit; however, the base unit must be
unplugged during cleaning.
6
Periodically clean the laser scanner window with a clean, dry cloth.
7
Document maintenance by selecting the forward arrow on the Main Menu
Screen. This will toggle to the Main Menu 2 Screen. Select Maintenance
and add the comment “Cleaned Meter”.
XVII. REFERENCES
A. Accu-Chek Comfort Curve Test Strip package insert. Roche Diagnostics 2004.
B. Accu-Chek Comfort Curve Linearity Test Kit package insert. Roche Diagnostics 2001.
C. Accu-Chek Comfort Curve Glucose Control Solutions package insert.
Diagnostics 2005.
Roche
D. Accu-Chek Inform System Operator's Manual, Roche Diagnostics 2004.
E. Burtis, C.A., Ashwood, E.R., Tietz, N.W., (1994). Textbook of Clinical Chemistry, 3rd
Ed. Philadelphia: W.B. Saunders Co., p.2112.
XVIII. REVISIONS
June 2007 Procedure written and in use.
October 2007 Revised neonatal high critical value per NS 700-13 and lowered the
reportable range to 20 mg/dL for NNICU and NBN patients.
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
May 2008
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Page 14 of 15
Added two additional Troubleshooting protocols in anticipation of
operator lockout issues for June 2008.
November 2008Amended the Maintenance section to comply with Infection Control
standards.
Authors:
Steven F. Lee, MBA, MT(ASCP)
Kevin B. Stuteville, MBA, MT(ASCP)
C:\Users\bwabbo\WORK DOCs\Projects\02-16-09 Pathology site addon\Inform Glucose.doc
Whole Blood Glucose Accu-Chek Inform System
Adopted: 6/07; Rev. 10/07; 06/08
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