USER GUIDE

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INTRODUCTION

eCQAP is part of Clinical Diagnostics Solutions’ (CDS) quality assurance program. eCQAP allows organizations using CDS instruments to upload their Controls data and compare it with other instruments within the same peer group on a monthly basis for quality assurance purposes.

eCQAP allows users to access multiple features over the internet via a web browser. In order to access eCQAP you will need to be enrolled in CQAP. You will need Log-in credentials you may obtain from your CDS technical support representative.

The following is a list of the main features currently available on eCQAP:

  • Secured Log in.
  • Data Submission.
  • Report Visualization.

This guide provides an overview of the eCQAP web interface and on how to use its features.

WEB INTERFACE

The following sections will provide an overview of the web interface and its main features.

LOG IN

 eCQAP log in page:

FEATURES:

  1. LAB ID: Unique Identifier Provided by CDS to eCQAP user.
  2. PASSWORD: Unique password provided by CDS to eCQAP user.
  3. FORGOT PASSWORD: Allows user to change the password by sending a link to the registered e-mail.
  4. FORGOT LAB ID: Allows user to retrieve the lab ID by sending information to the registered e-mail.
  5. HELP: Link to user Log in specific help topics.

USER PORTAL

USER PORTAL-HOME

This is where you have your options to view, submit, review, and edit data.

User home page:

FEATURES

  1. RECENT REPORTS: Displays a list of recent reports associated with your lab ID.
  2. DETAILS: Displays content of user uploaded data that has not been processed.
  3. REPORT: Displays report of user uploaded data that has been processed.
  4. SDI CHARTS: Displays Historical SDI Graph of report related instrument.
  5. HELP: Link to user View Reports specific help topics.

DETAILS

Displays content of user uploaded data that has not been processed.

Non-processed report and edit pages:

FEATURES

  1. EDIT RESULTS: Allows user to edit report data prior to processing.
  2. SAVE: Allows user to save edited data. The save button will appear after you have clicked on the “Edit Results” link.
  3. HELP: Link to data “Edit” specific help topics.

Note: Digitally uploaded data cannot be edited.

REPORT

Displays report of user uploaded data that has been processed.

Processed report page:

FEATURES

  1. VIEW REPORT: Visualize Report Data.
  2. EXPORT TO PDF (Optimized for Printing): View report as PDF on browser.
  3. DOWNLOAD PDF (Optimized for Printing): Save report as PDF on local storage.
  4. FIND: Via browser Find feature (Ctrl+F).

SDI CHART

Displays Historical SDI Graph of report related instrument.

Historical SDI Graph Page:

FEATURES

  1. VIEW CHART: Visualize SDI Graphs.
  2. PRINT: Via Browser Print Feature (Ctrl+P).
  3. FIND: Via browser Find feature (Ctrl+F).

USER PORTAL-SUBMIT RESULTS

This page allows users to upload data to e-CQAP. Data can be uploaded either manually or digitally.

Submit results Page:

FEATURES

  1. SELECT REFERENCE INFORMATION: Allows user to select data reference information.
  2. MANUAL DATA ENTRY: Allows user to input data manually for processing.
  3. DIGITAL DATA UPLOAD: Allows user to upload data for processing.
  4. SUBMIT: Allows user to submit data.
  5. HELP: Link to data “Submit” specific help topics.

ABOUT

This Tab provides general information about e-CQAP.

CONTACT

This Tab provides contact information for e-CQAP.

HELP

This Tab provides help information for e-CQAP.

HELLO LAB!

This Tab allows user to change the eCQAP password. Please note the following guidelines when creating passwords:

  • At least one alpha or numeric character.
  • At least one numeric character (‘0’-‘9’).
  • At least one uppercase alphanumeric character(‘A’-‘Z’).
  • At least 6 characters long.

You should receive an email within a few minutes with a link to reset your password. If you do not receive an email please contact us via our contact us page.

LOG OFF

This tab logs users off from eCQAP.

PROCESSES

The following section provides details on how to use the various related features of eCQAP.

LOG-IN

You will need to log in to eCQAP in order to view or upload your data. Two pieces of information are needed to log in: Lab ID and Password. These two pieces of information are provided to you by your CDS technical support representative. Please note that for security purposes eCQAP will ask you to reset your password on your first login.

If you are an existing CDS customer and do not have an e-mail on file, after you log in for the first time, you will be asked for your e-mail address. This is required to allow better communication between eCQAP and customers. Your e-mail address will be strictly used for CQAP related purposes, such as reminders of due dates, notification of reports availability and new system features.

LOGGING IN

Required Information

  • Lab ID.
  • eCQAP Password.

Steps

  1. Using your web browser go to www.vdatum.com.
  2. Click on “Log in” link located in the center of the page or the top bar, right hand side.
  3. Type your Lab ID and Password.
  4. Click on “Log in” button at the bottom of the Log in page.
  5. If Log in is successful you will be directed to your eCQAP “HOME” page.

RETRIEVING A FORGOTTEN PASSWORD

 Required Information

  • eCQAP Associated e-mail.

Steps

  1. On your browser go to www.vdatum.com.
  2. Click on the “Forgot your password?” link.
  3. Type your eCQAP associated e-mail and Click on the “Submit” button.
  4. If the e-mail provided is associated with your eCQAP account you will receive a confirmation message and an e-mail will be sent to the e-mail provided.
  5. If the e-mail provided is not in the eCQAP system you will receive a warning and no e-mail will be sent.
    1. Note: If do not know your eCQAP associated e-mail you will need to contact your CDS technical support representative.
  6. Follow the link provided on the e-mail, this link will take you to a page to reset your password.
  7. Type your eCQAP Associated e-mail, the new password, and confirm the new password.
  8. Please make sure to follow the password security requirements.
  9. Click on the “Reset” button.
  10. If the e-mail and password are correct you will see a confirmation message with a link to the log in page.
  11. You can follow the link and use your new password.

 

RETRIEVING A FORGOTTEN LAB ID

 Required Information

  • eCQAP Associated e-mail.

Steps

  1. On your browser go to www.vdatum.com.
  2. Click on the “Forgot your Lab ID?” link.
  3. Type your associated e-mail and Click on the “Submit” button.
  4. If the e-mail provided is associated with your eCQAP account you will receive a confirmation message and an e-mail will be sent to the e-mail provided.
  5. If the e-mail provided is not in the eCQAP system you will receive a warning message and no e-mail will be sent. If do not know your eCQAP associated e-mail you will need to contact your CDS technical support representative.
  6. The sent e-mail will contain the eCQAP Lab ID associated with that e-mail.
  7. Now you can log in with your Lab ID and password.

DATA SUBMISSION

Labs can upload data to  eCQAP using the “Submit Results” feature. This feature will allow you to select data reference information and your instrument’s control run data.

DATA REFERENCE INFORMATION

The following is a list of the data reference information you will need to select:

  1. Instrument ID.
  2. Month and Year of data.
  3. Calibrator Lot.
  4. Calibration Date.
  5. Calibrated Parameters.

These fields are available for selection through the use of drop-down lists.

DATA SUBMISSION METHODS

Manual Data Submission

eCQAP allows you to enter your lab’s control run data in the “Submit Results” page by typing the data from the Monthly CQAP Statistical Printout including:

-Submission reference information.

-N, Mean and 1SD for the run parameters.

In order to minimize data input errors and to optimize data input, eCQAP has embedded auto-fill and verification capabilities as described below:

N Autofill:

Once the “N” is entered for the first data parameter in the “Submit Results” page, the web platform will auto-fill the “N” for all other parameters with this first value. These values are editable so you can modify them if they are not the same.

Acceptable Mean Range Verification:

Mean values will be checked against an acceptable criteria set of ranges during submission. If any of the mean values entered is outside of these criteria, eCQAP will highlight which parameter(s) mean is out of the acceptable criteria and provide information on the acceptable range.

Required Information

  • Lab ID.
  • eCQAP Password.
  • Printed Instrument’s Monthly CQAP Statistical Printout.

Note: Please check your Instrument’s manual for instructions on how to obtain this printout.

Steps

  1. Log in to eCQAP using your credentials.
  2. Click on the “Submit Results” Tab on the top left menu of the page.
  3. Select the following reference information data using the drop down lists:
    1. Instrument ID.
    2. Control Lot.
    3. Month of data been submitted.
    4. Year.
    5. And calibrator information if needed.
  4. Populate the N, Mean, and 1SD data for the various parameters.
  5. Click the “Submit” button.
  6. If all the required reference information is selected and data provided is correct the submission will be successful. You will receive a confirmation message of the successful submission. eCQAP will notify you of an incorrect data submission, thus preventing data upload.

 Digital Data Submission

eCQAP allows you to load your lab’s control run data in a digital format. Your Monthly CQAP Statistical data can be downloaded to a USB storage device and uploaded on eCQAP from a PC. In order to reduce the possibility of uploading incorrect file information digitally, eCQAP has embedded user reference information and file structure verification capabilities. eCQAP will check that the file uploaded matches the reference information selected, verifies the file integrity, and let the user know if there is a problem.

IDENTIFYING YOUR M-SERIES txt FILES

When saving your M-Series files to a USB drive, it is important to understand all components of the file name in order to adequately select the file desired for eCQAP submission. The file name provides useful information on identifying your files.

IMPORTANT! Your file name will NOT contain the lot number of your sample saved. That means, in order for you to identify which file corresponds to which lot number, you’ll have to use the following steps:

  1. Always save your files in order. First save the LOW control, then NORMAL control, then HIGH control. Repeat if saving more kits.
  2. If you saved your files in order (L,N,H), then open the folder where your files where saved in your USB drive, then on top menu bar, click on “View”, then “List”. This will display the files you just saved (see image below)

By seeing your files in this format can identify them by the last 3 digits on file name (File with smallest last digits was the first file saved = LOW con). See image below:Below you will find an explanation of the file name you will encounter, and what each component of the file name means.

Monthly QC data:

Example: This file below was saved on 02/25/2015, containing Monthly QC data for the whole month of February 2015 for specific lot chosen.

Description:

BM = Boule Medical

14097 = Instrument SN

Q = Sample Type

201502 = QC year and month – yyyymm format (i.e.: in this case shown, Feb 2015)

20150225 = Date file was saved in USB – yyyymmdd format (i.e.: in this case shown, 02/25/2015)

112527 = File unique identifying digits

Required Information

  • Lab ID.
  • eCQAP Password.
  • Downloaded Monthly CQAP Statistical data.
  • Please check your Instrument’s manual for instructions on how to obtain this data.

Steps

  1. Log in to eCQAP using your credentials.
  2. Click on the “Submit Results” Tab on the top of the page
  3. Select the following reference information data using the drop down lists:
    1. Instrument ID.
    2. Control Lot.
    3. Month.
    4. Year.
    5. And calibrator information if needed.
  4. Click on the “Choose File” button.
  5. Browse to the location where your downloaded Monthly CQAP Statistical data is located.
  6. Select the file and click open.
  7. Click the “Submit” button.
  8. If all the required reference information is selected and data provided is correct, the submission will be successful. You will receive a confirmation message of the successful submission. eCQAP will notify you of an incorrect data submission, thus preventing data upload.

REPORT VIEWING

REPORT TYPES

Processed

Reports generated for data submitted by submission deadline (Currently the 6th day of the following month). Processed reports contain both your data and your Peer Group data. Additionally you can view the SDI Graphs for the report related instrument. The SDI graphs contain 6 data points including the month being processed and the 5 previous months for reference. These reports cannot be edited.

Non-Processed

These reports contain data submitted prior to the data submission deadline. Non-Processed reports contain just your data for the specific lot and month. They will become processed reports after the data submission deadline. Non-Processed reports can be both editable and non-editable depending on how the data was uploaded.

  • Non-processed, manually uploaded data is editable.
  • Digitally uploaded data cannot be edited.

 Required Information

  • Lab ID.
  • eCQAP password.

Steps

  1. Log in to eCQAP using your credentials.
  2. Click on the “View Reports” Tab on the top left menu of the page.
  3. This should take you to the “Reports” page and display a list of both non-processed and processed reports.
  4. For processed reports click on the “Report” link of the report you want to view.
  5. Once you open the report, you will see all your statistical data for the specific Control lot # and month chosen.
  6. For non-processed reports click on the “Details” link of the report you want to view.

DATA EDITING

If there are any errors in the uploaded data, manually submitted data that has not been processed can be edited after submission, if needed. Processed reports and digitally uploaded data cannot be edited.

Required Information

  • Lab ID.
  • eCQAP Password.
  • New data to upload.

Steps

  1. Log in to eCQAP using your credentials.
  2. Click on the “View Reports” Tab on the top left menu of the page.
  3. This will direct you to the “Reports” page and display a list of both non-processed and processed reports.
  4. Click on the “Details” link of the report you want to edit.
  5. This will show your submitted data for the specific Control lot # and month chosen.
  6. Click on the “Edit Results” link at the bottom of the page.
  7. This will load a page where you can edit your data.
  8. Once you have updated your data click on the “Save” button at the bottom of the page.
  9. If all the updated data is correct the submission will be successful and you will receive a confirmation message. eCQAP will notify you immediately if submission was unsuccessful. A message will appear on the top of the page with the parameter(s) mean that is out of the acceptable criteria and providing information on the acceptable range. Data will not be updated until data is corrected.