Conducting this test exposes the operator to potentially infectious material. Standard precautions, including glove use are required for this procedure

• Conducting this test exposes the operator to potentially infectious material. Standard precautions, including glove use are required for this procedure.

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.

• 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..

The A1C represents a measure of glycemic control over the preceding

• The A1C represents a measure of glycemic control over the preceding

• 2-3 months

The United Kingdom Prospective Diabetes Study

• 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

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.

• 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%".

Weekly, and as needed:

• Weekly, and as needed:

• Turn the analyzer off and unplug.

• Dampened with water or alcohol, wipe down the exterior, then dry. If necessary, disinfect with 1 part bleach plus 9 part water solution, allowing to sit on the analyzer for 10 minutes.

• Wipe with water then dry.

• Plug in and turn on unless further maintenance is required.

Reagent Cartridges

• 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.

Reagent Cartridges

• Reagent Cartridges

• All unopened test cartridges may be used until the manufacturer's expiration date when refrigerated at 2 - 8*C. Kits not in use will be stored in the laboratory specimen refrigerator.

• Kits in use may be stored at room temperature (15-30*C) for up to 3 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).

• Prior to use, allow the reagent cartridge to warm to room temperature (64-86 * F) for at least 15 minutes in an unopened foil pouch. Information code 210 will be displayed if the cartridge is too cold when used.

• The reagent cartridge must be used within 10 minutes after opening the foil pouch.

• True

• False

TRUE

• TRUE

• ….The temperature of the laboratory fridge must be checked and documented daily by MA staff with action taken for out of range temperatures

• True

• False

FALSE

• 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

False

• 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.

• 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

Controls

• Controls

• Un-reconstituted control material is stable until the expiration date marked on the package when stored refrigerated at 2 - 8*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

Run a normal and abnormal control under the following conditions:

• 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

The measured value should be within the acceptable limits stated for the control material. Consult the Afinion HbA1c Control package insert.

• 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.

If no procedural errors are detected:

• 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.

Collect and test specimen on all diabetic patients without a HgbA1C in the last 2- 3 months.

• Collect and test specimen on all diabetic patients without a HgbA1C in the last 2- 3 months.

Switch on the Afinion AS100 Analyzer.

• 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.

Follow procedure for finger stick

• Follow procedure for finger stick

• Holding the glass capillary holder at an angle, touch only the tip of the capillary to the drop of blood on the finger until the capillary is filled. It is not possible to overfill. Avoid air bubbles.

• Do not wipe capillary tube.

• Once the capillary is filled, analysis of the Test Cartridge must start within 1 minute.

Identify patient using two patient identifiers (name and DOB)

• 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.

Insert the capillary tube into the Test Cartridge and then insert the Test Cartridge in the Analyzer. The analysis time is 3 minutes and 20 seconds.

• Insert the capillary tube into the Test Cartridge and then insert the Test Cartridge in the Analyzer. The analysis time is 3 minutes and 20 seconds.

• Record the test results in the EMR according to the laboratory guidelines. The results will also be stored in the Analyzer electronic result records.

• Remove the Test Cartridge from the Analyzer and dispose in biohazard trash.

• Remove gloves, dispose of in regular trash and perform hand hygiene.

• Once you are confident that you are comfortable with all the

• materials presented, proceed to the A1C Testing Using the Afinion AS-100 post test at http://www.classmarker.com/

• Your username is the first initial of your first name followed by

• your full last name. Your password is= nwhealth