Bayer A1c now+ Running a Test




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Staff preparation sheet for community screening with Bayer A1c Now+

Warm Springs Diabetes Prevention Program


arm Springs Diabetes Prevention Program

Bayer A1C Now+

Running a Test



Subject: Bayer A1CNow+ – Running a Test
Effective Date: May 17, 2011 Revised Date:
Distribution: Diabetes Prevention Program staff
Purpose: To ensure that running a test is done correctly. The goal is to

Provide accurate health care while screening for pre-diabetes in the community.



Methods: The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to screen for glycemic control. The Bayer A1CNow+ test is a CLIA-waived test. A CLIA Certificate of Waiver is needed to perform testing and is located in the Coordinator Office of the Diabetes Program. Calibration of the A1CNow+ is performed with a set of blood samples that have been value-assigned by a national glycohemoglobin Standardization Program certified laboratory using an NGSP reference method.
Prepare for testing:
The Test Kits

  • A1CNow+ Monitor

  • A1CNow+ Test Cartridges

  • Patient result labels

  • Sample Dilution Kit consisting of Sampler and Blood Collector


Preparing for Testing

  • All parts of the kit need to be at the same temperature;

64° – 82° F

  • If the kit has recently been at high temperatures (>82°) or in the refrigerator, keep at room temperature for at least one hour before use.

  • Avoid running the test in direct sunlight, on hot or cold surfaces or near sources of heat or cold.

  • To ensure that storage conditions have not affected the product, run a control sample before running a patient sample if the test kit has been stored for more than a month and it has been at least a month since the last testing

  • Ensure lot #’s match


Procedure for collecting the Sample

  • Always use gloves

  • Cleanse the finger using alcohol. Allow the area to air dry

  • Use a lancet and firmly prick the finger (Properly dispose of the lancet)

  • Allow a good drop of blood to form before sampling

  • Apply direct pressure to the wound site with a clean gauze pad

  • See ‘quick guide’ for steps to specimen collection using the Blood Collector and Sampler Body located in the Dilution Kit.

  • Review instructions located in the package insert

  • Once the Test Cartridge pouch is opened it must be used within 2 minutes


Running Samples on the Analyzer

  • See ‘quick guide’ for steps inserting the Test Cartridge into the monitor and dispensing the blood sample into the cartridge

  • Once pouched Test Cartridge is opened test is to be run within 2 minutes. The whole process needs to happen within 15 minutes

  • Once the blood sample is dispensed into the cartridge do not handle the monitor again until the test is complete

  • It takes 5 minutes to obtain results. The monitor will display a count down, and then will display QCOK, then the result. It will finally show the number of tests left.

  • The result cycle remains displayed for 60 minutes or until a new Test Cartridge is inserted

  • The monitor is reusable, to run another test use a new Sampler and Test Cartridge from the same kit and return to step 1 of the instructions.


Important information codes

Code

Cause

Or 1

Blood sample may have too little Hemoglobin

OR 2

Blood sample may have too much Hemoglobin


OR 3

Blood sample has too little HbA1c or not enough blood was collected

OR 4

Blood sample has too much HbA1c or too much blood collected

OR 5

Monitor temperature too low < 64°

OR 6

Monitor temperature too high > 82°

<4.0

A1C is less than 4%

>13.0

A1C is greater than 13%

QC 2

Test Cartridge has already had a sample added to it (Do not remove and reinsert cartridge adding sample, use a new test cartridge and sample dilution kit.)

QC 6

Sample added before to Test Cartridge before SMPL display

QC 7

The Test Cartridge remained in the Monitor without sample addition for 2 minutes after SMOL prompt

QC30-33

Monitor was unable to obtain a valid initial reading

QC50-51

QC 55-56


Insufficient sample delivered to the Test Cartridge

All other QC codes

Quality control checks did not pass. Call Bayer Tech Support. Test must be repeated with new test Cartridge and Sample Dilution Kit

E1 to E99

Fatal Error. Call Bayer Technical Support




Please refer to the package insert for more detailed information


Control Testing
How Often

For CLIA waived labs it is recommended to analyze with controls;



  1. With each new shipment of kits

2. With each new lot

3. At least every 30 days

4. When training new users

5. Anytime an unexpected test result is obtained



Use of Controls

Controls are available in the WSHWC laboratory. Permission has been given by George Robinson, Supervisor Laboratory Services, for assistance with Control Testing. Staff will request a laboratory staff member to assist when testing is necessary. A log will be kept in the WSHWC lab for documenting control testing. Instructions from the manufacturer are noted below;



  1. Allow control to reach room temperature before use which takes about 30 minutes

  2. Mix control well by thoroughly shaking the vial for 30 seconds

  3. Inspect the vial to ensure that the control solution is homogenous

  4. Analyze the control using the procedures described under Specimen Collection and Running samples on the Analyzer.

  5. Compare the test result with the values listed on the front page of the Afinion HbA1c Control Package insert.


If Results are not within the acceptable range

  1. Do not analyze patient samples

  2. Check control vial label for expiration date

  3. Ensure that the control has not been open for more than 60 days

  4. Verify controls and cartridges have been stored properly

  5. Verify there is no sign of bacterial or fungal growth in the control vial.

For complete and detailed instructions refer to the Professional-Use Product Insert located in each new kit. A copy can also be located in the Diabetes Prevention Office in the production information notebook.


All staff using the equipment must be trained by Diabetes Program staff. The training date, name of staff member performing the skill is to be recorded on the skills checklist.

Warm Springs Health & Wellness Center

Warm Springs Model Diabetes Program

Blood Glucose Monitoring Checklist

Blood Glucose Monitor


No Experience


Has knowledge/

Skill

Demonstrates Knowledge/

Skill

Date Inservice/

Training Completed

Initials for completion




WS Model Diabetes Program
































































WS Tribal Community Health Representatives
















































WS Public Health Nursing
















































Nutrition
















































SDPI Diabetes Prevention Program































































































































































































































































































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