1. A1C Testing USING THE Afinion AS-100
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For Medical Clinical Staff
WellOne Primary Medical and Dental Care

2. WARNING
Conducting this test exposes the operator to potentially infectious material. Standard precautions, including glove use are required for this procedure.
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3. A1C Basics
A1C (also known as Hemoglobin A1C, HgbA1C, HbA1c) or Glycated Hemoglobin) is a bood test that reflects average blood glucose over the last 2-3 months.
The goal for most people with diabetes is less than 7%.
An A1C of 7% corresponds to an average blood glucose level of 170 mg/dL..
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4. A1C Basics
The A1C represents a measure of glycemic control over the preceding
2-3 months
The goal for most patients is an A1C value of 7 or less
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5. A1C Basics 25% for small vessel disease 21% for retinopathy (eye)
The United Kingdom Prospective Diabetes Study
(UKPDS) is study that showed, among people with type 2
diabetes, improved glycemic control
(average A1C = 7% vs average A1C = 7.9% in the
conventionally treated group) led to a reduction in risk by:
25% for small vessel disease
21% for retinopathy (eye)
33% for albuminuria (kidneys)
16% for myocardial infarction (heart attack)
24% for cataract extraction
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6. A1C Basics
The A1C test will be considered a diagnostic test at WellOne facilities. Patients with values >14% should be referred to a CLIA Laboratory for quantification.
HbA1c assay optimal performance occurs on specimens with total hemoglobin concentrations between 7 and 24 g/dl. Specimens from patients with severe anemia or polycythemia whose hemoglobin concentrations are less than 7 g/dl or greater than 24 g/dl should be tested using a different assay method.
Specimens containing >10% Hemoglobin F may yield lower than expected HbA1c results with this test. Do not compare results for such patients to published normal or abnormal results.
Results will be reported in percent (%) Glycated Hemoglobin.
Results preceded by a < (less than) sign are below 2.5%. This is a rare condition and should be reported as "less than 2.5%". Results preceded by a > (greater than) sign are greater than 14.0% and should be reported as "greater than 14.0%".
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7. A1C Testing USING THE Afinion AS-100: Cleaning
Weekly, and as needed:
Turn the analyzer off and unplug.
Dampen with water or alcohol, wipe down the exterior, then dry. If necessary disinfect with approved disinfectant, allowing to sit on the analyzer for 10 minutes, then wipe with water and dry.
Plug in and turn on unless further maintenance is required.
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8. A1C Testing USING THE Afinion AS-100: STORAGE AND STABILITY
Reagent Cartridges
Upon receipt, check the temperature indicator located on the inside top lid of the carton. Do not use if indicator has turned red. Follow instructions located on the carton for receiving a replacement kit.
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9. A1C Testing USING THE Afinion AS-100: STORAGE AND STABILITY
Reagent Cartridges
Unopened test cartridges may be stored in the refrigerator at 2-8°C (36- 46°F) until the expiration date noted on packaging.
Unopened test cartridges may be stored at room temperature for 90 days.
When using refrigerated test cartridges, the test cartridge must reach an operating temperature of 18-30°C (64-86°F) before use. Upon removal from refrigerated storage, leave the Test Cartridge in the unopened foil pouch for at least 15 minutes. Information code 210 will be displayed and no test result obtained if the Test Cartridge is too cold when used.
Upon opening a testing cartridge box to be left at room temperature, write the date the kit was placed at room temperature and the date the kit will expire (3 months from this date).
Once the foil pouch is opened, the cartridge must be used within 10 minutes.
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10. True or false: A1C reagent kits not in use must be stored in the laboratory specimen refrigerator
True False
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11. THE CORRECT ANSWER IS ……
TRUE
….The temperature of the laboratory fridge must be checked and documented daily by MA staff with action taken for out of range temperatures
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12. True or false: A1C reagent kits in use stored at room temperature in the laboratory are stable for 2 months after placing at room temperature
True False
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13. THE CORRECT ANSWER IS ……
FALSE
Kits in use may be stored at room temperature (15- 30*C) for up to 3 months (not 2 months).
Upon opening, write the date the kit was placed at room temperature and the date the kit will expire (3 months from this date).
….The temperature of the laboratory room must be checked and documented daily by MA staff with action taken for out of range temperatures
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14. True or false: After opening the A1c reagent foil pack, the test kit must be used within 1 hour
True False
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15. THE CORRECT ANSWER IS ……
False
…. The reagent cartridge must be used within 10 minutes after opening the foil pouch. Do not refrigerate after the foil pouch has been opened.
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16. 15, 20 10, 5 15, 10 Click here to select this answer
When taking a test kit from the refrigerator, the test kit must be allowed to sit at room temperature for ________ minutes in the foil packet and ___________ minutes when removed from the foil packet before using or erroneous results will occur
15, 20 10, 5 15, 10
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17. The correct answer is 15, 10………………….
When taking a test kit from the refrigerator, the test kit must be allowed to sit at room temperature for ________ minutes in the foil packet and ______ minutes when removed from the foil packet before using or erroneous results will occur 15 10
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18. A1C Testing USING THE Afinion AS-100: STORAGE AND STABILITY
Controls
Un-reconstituted control material is stable until the expiration date marked on the package when stored refrigerated at *C.
Once prepared, the material may be used for up to 60 days after reconstitution if stored at 2 – 8 C. Be certain to note the date prepared on each bottle. Material stored otherwise must be discarded after one day of use
A1C controls are stored in the refrigerator
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Stable 90 days after mixing
Stable until
expiration date

19. A1C Testing USING THE Afinion AS-100: control testing
Run a normal and abnormal control under the following conditions:
With each new shipment or lot number
Monthly, if not previously done within this time period
Anytime an unexpected test result is obtained
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20. A1C Testing USING THE Afinion AS-100: control testing
The measured value should be within the acceptable limits stated for the control material. Consult the Afinion HbA1c Control package insert.
If the result obtained for the Afinion HbA1c Control is outside the acceptable limits, make sure that:
Patient samples are not analyzed until control results are within acceptable limits.
The control vial has not passed its expiration date.
The control vial has not been in use for more than 30 days.
The control vial and test Cartridges have been stored according to recommendations.
Correct any procedural error and re-test the control material.
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21. A1C Testing USING THE Afinion AS-100: control testing
If no procedural errors are detected:
Examine the laboratory’s quality control record to investigate the frequency of control failures.
Ensure that there is no trend in out-of-range quality control results.
Re-test the control material using a new control vial.
Patient results must be declared invalid when controls do not perform as expected. Contact your customer service representative for advice before analyzing patient samples.
Record incident in quality control manual and report to supervisor.
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22. A1C Testing USING THE Afinion AS-100: Standing order for ma staff
Collect and test specimen on all diabetic patients without a HgbA1C in the last 2- 3 months as well as indicated for diabetic screening.
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23. A1C Testing USING THE Afinion AS-100: testing Steps
Switch on the Afinion AS100 Analyzer.
Allow the Test Cartridge to reach operating temperature (64-86ºF). Open the foil pouch just before use.
Be sure to properly label the Test Cartridge with sample ID. The Test Cartridge has a dedicated ID area.
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24. A1C Testing USING THE Afinion AS-100: testing Steps
Identify patient using two patient identifiers (name and DOB)
Explain procedure to patient in culturally appropriate, age appropriate terms.
Gather all necessary equipment and supplies prior to start of the procedure.
Inspect all equipment and supplies for damage, general integrity and expiration date- do not use any damaged or expired materials
Perform hand hygiene before and after patient contact; before and after donning gloves.
Don all appropriate personal protective equipment prior to conducting procedure. Gloves are required.
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25. A1C Testing USING THE Afinion AS-100: testing Steps
1. Follow procedure for finger stick and collect specimen using the supplied capillary tube.
2. Insert the capillary tube into the Test Cartridge and then insert both in the Analyzer. (Do not use test cartridges that have been accidentally dropped). The analysis time is 3 minutes and 20 seconds. Once the capillary is filled, analysis of the Test Cartridge must start within 1 minute. Discard and repeat first 2 steps if this is not completed within 1 minute.
3. Enter patient related information.
4. Record the test results in the medical record.
5. Remove the Test Cartridge from the Analyzer and dispose in biohazard trash.
6. Perform hand hygiene.
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26. 1 minute 10 minutes 5 minutes
A specimen should be processed as soon as possible and under no circumstances should a specimen be processed that has been in the glass capillary holder for more than ________________
1 minute 10 minutes 5 minutes
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27. The correct answer is………………………….
No longer than………….
1 MINUTE
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28. You have reached the end of this program…..
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