NHS Health Check Internal/External Quality control Crib Sheet. Table of Contents. Alere Afinion HbA1c Control (Internal)

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1 NHS Health Check Internal/External Quality control Crib Sheet Table of Contents Alere Afinion HbA1c Control (Internal) Page 2 WEQAS HbA1c Quality Control Assessment (External) Page 3 WEQAS Afinion Lipid Panel Control (Hybrid Internal and External) Page 4 WEQAS set up request form Page 5 QC Schedule (April December 2016) Image log in and QC submission help sheet Page 6 Page 7-8

2 For all testing you will need to ensure you order enough Alere Test cassettes to carry out quality control. Alere Afinion HbA1c Control (Internal) Delivered every other month in a small white box from ALERE. 2 months worth of tests in each box. o See QC Delivery Schedule Test once a month after receiving an from Alere, with link to ALERE image QC Test Page to record results. If you haven t registered with Alere to submit your results, please Alere at imagesupport@alere.com to request a login. Please run your QC test as soon as you receive it, if it is not practical to do so, the samples must be stored refrigerated (2 8 C). Opened controls are stable for 60 days. When running the QC test, allow the control to reach a temperature of C before use, which takes approximately 45 minutes. Mix the control thoroughly by shaking the vial for 30 seconds before use. Run the sample on your instrument as per instructions and then input the results into the Image portal, which will notify you of a pass or fail, based on the acceptable range for the Alere Afinion HbA1c. If you fail your initial test, you will be prompted to repeat the test via an link, click on the link to repeat the test.

WEQAS HbA1c Quality Control Assessment (External) Delivered every other month, shipped in a clear plastic container via Royal Mail. (see QC Delivery Schedule) Test as soon as the control kit arrives.

If you are unable to do so, the samples should be stored refrigerated (2-8 C) Instructions for use included in delivery of kit.

3 WEQAS HbA1c Quality Control Assessment (External) Delivered every other month, shipped in a clear plastic container via Royal Mail. (see QC Delivery Schedule) Test as soon as the control kit arrives. (These controls degrade rapidly and should be run as soon as possible after receipt). If you are unable to do so, the samples should be stored refrigerated (2-8 C) Instructions for use included in delivery of kit. If you have been unable to run the sample immediately, and the controls have been stored in the fridge, they can be run directly from the refrigerator. Mix thoroughly by gently inverting 8 10 times. All results should be submitted via the WEQAS portal, which can be accessed via a link on the Image Portal (see screenshot below). The link below will take you to the Alere page. Click on the WEQAS portal link below to upload your HbA1c EQA Results. WEQAS PORTAL It will ask you for your ID (which is your address) and password. To obtain a login for the WEQAS portal, if you do not have one, submit the attached form via fax number , or click on the link below to download a copy. WEQAS REGISTRATION FORM

Hybrid Afinion Lipid Panel Control (WEQAS Internal and External) Delivered via Royal Mail, once a month (see QC Delivery Schedule) The samples arrive in a clear plastic container and there are 2

you are ready to run the tests, the controls can be used directly from the refrigerator. Mix thoroughly by gently inverting 8 10 times.

4 Hybrid Afinion Lipid Panel Control (WEQAS Internal and External) Delivered via Royal Mail, once a month (see QC Delivery Schedule) The samples arrive in a clear plastic container and there are 2 vials, Lipid control A & Lipid Control B - eg A201703A AND A201703B Please use lot number here NOT here If you are unable to run the samples immediately, store the controls refrigerated (2-8 C) Once you are ready to run the tests, the controls can be used directly from the refrigerator. Mix thoroughly by gently inverting 8 10 times. Once the results are available on your instrument screen, log into Image, using your address as your user name, and clicking on your serial number link on the QC test page Input the results in mmol/l on the Alere Image Portal, taking care to enter the correct level into the correct box on the portal screen. The Lot number of each level is in green print on the vial and will have already been entered into image (see screenshot below). If you fail your initial test, you will be prompted to repeat the test via an link.

Initial Interactive Website Registration Dear Colleague, Thank you for indicating an interest in accessing the interactive Weqas web site for reports and result entry.

5 Initial Interactive Website Registration Dear Colleague, Thank you for indicating an interest in accessing the interactive Weqas web site for reports and result entry. For security reasons, access levels must be authorised by your Head of Department. In order for us to process your request, please complete the form below and fax to Full lab access users will have access to all reports relating to your laboratory. We can provide more than one contact if you wish. This form may be copied as many times as required. Section access users will only have access to their named section, as registered in the Weqas database and indicated on Weqas input sheets and reports e.g. SCBU gases. Section Access users requiring access to more than 1 section will receive a separate username for each section required. We can also provide access on a group / regional basis; however, signed permission from each laboratory head of department will be required. Please contact Weqas to obtain a Region registration form. Lab Code AKW Hospital / Organisation/GP Surgery Full lab access users Name of Lab User address (please print clearly) Name of Person Submitting QC (Name of Surgery) Section access users Weqas Section name Name of Section User Shropshire Commissioner address (please print clearly) mike.parry@help2changeshropshire.nhs.uk Mike Parry Practice Manager Practice QC Health Check Lead Practice Manager/Head Nurse Authorisation Signature Print name Title/Position Date: Please be aware, once a user name has been issued, it remains active until Weqas is notified that it is no longer required. It is therefore the responsibility of each participating lab to notify Weqas when a registered web user leaves a lab or changes their contact . Please submit a user amendment form WF-QL1-wwwamend to notify Weqas of changes in user status, so that we can ensure that access to your lab s performance data is only available to appropriate personnel. File name:wf-ql1-wwwregist1215 Date of Revision: 14/12/2015 Approved by: Sam Jones Version: 3.1 Page 1 of 1

6 Afinion QC Delivery Schedule 2016 Please Store all QC in fridge until ready to use, bring to room temperature before using. Run QC tests as close to delivery date as possible, but before the end date as below. Record WEQAS HbA1C EQA results on WEQAS website. Alere HbA1C IQC will be delivered bi-monthly (every two months) but test needs to be run monthly as indicated below. Please do not dispose of the Alere HbA1C vials after the first test, as sufficient QC sa ple fluid will be se t for two o ths QC testi g. Month June July August September October November December QC Type QC Deliver Date QC Test Date Results reported to HbA1C IQC Control in fridge June 14th - 30th W/C 13th June 14th - 30th HbA1C IQC W/C 18th July 18th - 30th W/C 18th July 18th - 30th HbA1C EQA W/C 18th July 18th -30th WEQAS HbA1C Control in fridge July 15th 27th W/C 15th July 15th 27th HbA1C IQC W/C 12th Sept 12th 24th W/C 12th Sept 12th 24th HbA1C EQA W/C 19th Sept 19th - 30th WEQAS HbA1C Control in fridge Oct 10th 22nd W/C 10th Oct 10th 24th HbA1C IQC W/C 14th Nov 14th - 26th W/C 14th Nov 14th - 26th HbA1C EQA W/C 14th Nov 14th - 26th WEQAS HbA1C Control in fridge Dec 12th - 24th W/C 12th Dec 12th - 24th

Access Login Upon accessing the Alere Image web portal, you will be presented with the Login page. Fig.

7 Alere Image is a web portal for customers and their authenticated users to manage and maintain their assigned Alere device(s). Alere Image supports the Alere Afinion AS100 Analyzer and Alere Cholestech LDX Analyzer to collate, analyse and report on QC data submitted from field deployed analysers. Access Login Upon accessing the Alere Image web portal, you will be presented with the Login page. Fig. 1-1 Enter the username and password provided by your administrator or Alere representative into the respective fields and click the Login button. Remember me Click to check the Remember me? option to enable your browser to save your username and password and automatically authenticate you onto Alere Image web portal for future visits. Note: This action is not advised for users who are using a shared computer. Fig. 1-1

Submit your QC test results Following the task link in the email you have been sent and you will gain access to the QC Test Results submission page.

Note: - Shut down your instrument fully before turning it over. Failing to do this can damage the instrument.

8 Submit your QC test results Following the task link in the you have been sent and you will gain access to the QC Test Results submission page. You may be asked to add your instrument serial number before you can add your results. This can be found on the underside of your instrument. Note: - Shut down your instrument fully before turning it over. Failing to do this can damage the instrument. The resulting page will display the QC test details (Fig 14-2), To submit your QC test results, you may be requested to enter the required lot numbers from the QC Packaging and QC result measurements. Then click the Submit button at the bottom of the QC Test Result panel to commit your submission. As a final check, upon submission you will be prompted to confirm the device serial number and site are correct. Note: if you attempt to submit a QC test record without populating the required information or provide a result outside of the specified range of the device being tested, then you will be prompted to address the highlighted field before you can complete the submission. Fig If your QC test result has been submitted successfully, you will see the following confirmation message displayed on screen: Your QC test has been submitted successfully. Thank you. Click OK, to be returned to the dashboard view where you can monitor the system for further pending QC tasks. Note: If your QC test result submission is unsuccessful, i.e. you have failed to provide results within the specified range of the QC material, you will be prompted to re-run your QC test and the QC administrator will be notified of the failure, to assist as required. Alere Image QUICK User Manual Page 2 of 2

NHS Health Checks Quality Control testing guide

NHS Health Checks Quality Control testing guide Contents HbA1c Quality Control Page 2-3 (Hybrid Internal and External) Lipid Quality Control Page 4 (Hybrid Internal and External) QC Schedule (June November