A1C TESTING USING THE AFINION AS-100 WellOne Primary Medical and Dental Care Click here to move on...

A1C TESTING USING THE AFINION AS-100

WellOne Primary Medical and Dental Care

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For Medical Clinical Staff

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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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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A1C Basics

The A1C represents a measure

of glycemic control

over the preceding

2-3 month

s

The goal for most patients is an A1C value of 7 or less

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A1C Basics

The United Kingdom Prospective Diabetes Study(UKPDS) is study that showed, among people with

type 2diabetes, improved glycemic control (average A1C = 7% vs average A1C = 7.9% in theconventionally 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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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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A1C Testing USING THE Afinion AS-100: Cleaning

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.

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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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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.

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True or false: A1C reagent kits not in use must be stored in the laboratory specimen refrigerator

True

False


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answerClick here to select this

answer

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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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




answer


FALSEKits 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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True or false: After opening the A1c reagent foil pack, the test kit must be used within 1 hour

True

False




answer


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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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





answer

The correct answer is 15, 10………………….

When taking a test kit fromthe refrigerator, the testkit must be allowed to sit at room temperature for ________ minutes in the foil packet

and ______ minutes when

removed from the foil packetbefore using or erroneousresults will occur


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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

A1C controls are stored in the refrigerator

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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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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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. Click

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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.

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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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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.

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Do not process any specimen that has remained in the glass capillary for longer than one minute

prior to analysis.


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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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



answer


answer


answer

The correct answer is………………………….


No longer than………….

1 MINUTE

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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.

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You have reached the end of this program…..

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= nwhealthClick here to go back and review

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