Data Transfer SOP – Imaging Sites

Data Transfer SOP - Imaging Sites

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Data Transfer SOP – Imaging Sites

By: Ran Klein, University of Ottawa Heart Institute.

Creation Date: 2011-11-21 Last Updated: 2013-03-22

Intended Audience: These operating procedures are intended for participating imaging sites in the IMAGE-HF

project, including:

- Interpreting physicians

- Research coordinators

Background: Standardization of image interpretation is a key feature of the IMAGE-HF project.

Standardization is conducted by QA labs of respective imaging modalities and indicators as

listed below. All participating sites are responsible for image interpretation and reporting. A

subset of images will be selected and sent to the corresponding QA lab for interpretation.

Feedback will be provided to the imaging site, to standardize image quality and interpretation.

For cases with discordant interpretations, consensus will be reached and documented.

The following table summarizes the IMAGE-HF QA lab sites and contact persons.

Study CRF Modality Indication QA Lab QA lab director

QA Contact

1A HF-15 PET, SPECT

Ischemia UOHI Rob Beanlands Ran Klein

HF-12 PET, SPECT

Viability UOHI Rob Beanlands Ran Klein

HF-15 CMRi Ischemia London James White Irene Pauchard

HF-13 CMRi Viability London James White Irene Pauchard

1B HF-18 Echo Non-ischemics UOHI Kwan Chan Ran Klein

HF-19 CMRi Non-ischemics Edmonton Ian Paterson Ian Paterson

1C HF-21 CTA Anatomy UOHI Ben Chow Ran Klein

HF-22 ICA Anatomy MHICC Philippe L’Allier Philippe L’Allier

The IMAGE-HF database will automatically flag patients to be used as QA when the modality

forms (i.e. HF 12, HF13, HF15, HF18, HF19, HF21, & HF22) are entered to the APA system (via

the web interface).


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Procedure Overview: The following flow diagram summarizes the QA procedure step-by-step from top to bottom.

Detailed explanations follow.

Consensus

Review

Stage

Enrollment

Clinical

Interpretation

QA Data Transfer

QA Interpretation

QA Comparison

Review and

consensus

Feedback

Anonymized Image

Data

Anonymized clinical

form

Completed HF##

HF1 Site Coord.

DTF Site Coord.

HF## Site Coord.

HF##C QA MD

HF##QA QA MD

QA?

HF##QA QA MD

Meets report & quality standard and interpretation agreement?

Done

Statistics

Coordinator No

Yes

QA MD

Yes

No

TCON QA MD &

Site MD

Submit

HF##QA QA MD

Submit

HF##QA QA MD

Save

HF##QA QA MD

Imaging Site QA Lab

Report transmitted to

Imaging Site QA MD

Legend

Italics – tasked person.


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The QA cases are automatically selected by the database and identified as the image modality

form is completed. A notification pop up message will be displayed, as demonstrated in the

figure below. QA patient information must be sent to the respective QA lab for co-interpretation

within 4 weeks of imaging procedure. The QA package will consist of:

Anonymized images (labeled according to IMAGE-HF tracking scheme)

Respective IMAGE-HF Case Report Forms (CRFs)

Clinical interpretation of the image

Data transfer forms (DTF) CRF

Saving CRF for Transfer

Saving the Image HF CRF for Attachment to DTF CRF 1. Immediately after the form has been submitted to the server, go to Sent Items tab and

locate the file you just submitted to the web. Normally it will appear on the first row of

the Sent Items tab.


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2. Click on the icon and the PDF file will be open for that case (see diagram below).

3. Click on the SAVE button to save this file to your computer

Notice that the file name will be random numbers and letters, as seen below:


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4. Select a location to save the file, and rename the file as form id project – site – number

(e.g. HF15_1A_01_0002) by putting the cursor before the .PDF. After you have clicked

Save, you can close the PDF file.

TIP! It is important you know where your file is located as you will need to attach this file

to the DTF form. It is recommended that you create a folder in your computer and

always save in the same location.


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Anonymize Data for Transmission !NOTICE - All data must be anonymized before transfer outside of the imaging site

Anonymize Image Data Images are to be anonymized by the imaging site to ensure patient confidentiality during image

transfer and storage. The following fields should be modified:

Field Name DICOM Field

New Value Value found in

Patient Name (0010,0010) Pt ID #NNNNN - SS-ss-RRRR - NNNNN (5digit) – Patient ID# - SS – Project (1A, 1B, 1C, or 2A) - ss – imaging site number - RRRR – randomized patient number

CRF

Patient ID (MRN) (0010,0020) Delete N/A

Patient DOB (0010,0030) Day = 01, Month & Year Unchanged N/A

Tip! As each institution is different, it is important that you review your patient file and remove

any other fields that may be used to identify the patient (e.g. addresses, referring physician).

Anonymize Clinical Interpretation Report Each site must resolve a method to delete patient identification information from the clinical

reports prior to transmission based on the report format and available tools.

Complete IMAGE-HF Data Transfer Form (DTF) CRF

Applies to all QA cases

Facilitates tracking of transferred data between imaging site and QA lab.

1) Open the DTF CRF from the FOLDER tab of IMAGE HF by either click on the icon

or the name of the file as indicated below:

2) Enter the Patient ID #, Project, Site and Number on the DTF form. The Date Sent and

Sender info including Name, email address and telephone will be automatically filled out for

you. See diagram below:


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3) Under the Data section, click on the Check Modality button, and the Modality and

Indication will be automatically prefilled in correspondence to the randomization # you have

entered.

4) If the Indication is Echo and CMR, please choose either Echo or CMR that will be submitted

with this DTF. Both of the Echo and CMR will need to be submitted, but separate DTF forms

must be submitted for each modality.

5) Anonymized Identifiers Section - Complete the following according to the anonymization

information entered in the image header:

- Name: pt id , Project + site+num (e.g. 00005 1A‐01‐0002)

- ID: blank

- DOB: day 01, and mm and yyyy (e.g. 01/03/1936)

Completing this section is important for uniquely identifying individual images at the QA

lab.

6) Transfer Method Section - Complete either Direct DICOM or FTP as the method used to

transfer the image data

- If FTP, please provide the folder or the path of the file where the data resides (e.g.

UOHI\1A\PT00005)

7) Clinical Interpretation Report & CRF(s) Section - Complete the following:

- Transfer Method – choose either Attachment via APA Web, FTP, or FAX.


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- If you choose Attachment via APA Web, make sure you click the Add Attachment(s)

button as indicated in the diagram below.

Attaching files to DTF

a) A new window will appear as demonstrated below:

b) Click on Browse button and you will be prompted to choose the file and the location of

your saved file.


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c) Click on file you want to attach and click Open.

d) Click on the Add button.

The attachment you have chosen will be then be added as indicated in the diagram

below.


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e) You may add additional files by repeating steps b) through d).

8) Click Finish when you are done, and then you will be directed back to your DTF form.

9) QA Lab Contact Information section ‐ This section does not need to be completed, it will

be automatically filled out for you, and it can be referred to for the data transfer information.


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10) After you press the SUBMIT button of the DTF form, follow the additional steps, as outlined

below, to submit the completed form and attachments to the server and the QA Lab lead for

review.

a) Click/select the Routing Completed option in the Send to area of the Routing for

Form HF_DTF window.

b) Add optional notes to indicate any appropriate information in the Subject field under

Notes.

c) Click on the Search button to get the list of QA site names you are sending to.

d) Type “core” in the search field, and click the Search button, and a list of all core labs

(i.e. QA core labs) will appear in the search results, as shown below.


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e) Select the appropriate QA Lab (User Name column) where the data is being sent to

(e.g. CORE - PET & SPECT).

NOTE: The User Name of the corelabs that is selected corresponds accordingly to

the QA labs, as indicated from the chart below:

Study CRF Modality Indication QA Lab QA lab director User Name

1A HF-15 PET, SPECT

Ischemia UOHI Rob Beanlands CORE_ PET & SPECT

HF-12 PET, SPECT

Viability UOHI Rob Beanlands CORE_PET & SPECT

HF-15 CMRi Ischemia London James White CORE_1ACMR

HF-13 CMRi Viability London James White CORE_1ACMR

1B HF-18 Echo Non-ischemics UOHI Kwan Chan CORE_Echo

HF-19 CMRi Non-ischemics Edmonton Ian Paterson CORE_1BCMR

1C HF-21 CTA Anatomy UOHI Ben Chow CORE_CTA

HF-22 ICA Anatomy MHICC Philippe L’Allier CORE_ICA


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f) Below is an example of the what you would see after the Submit button is pressed:


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Transfer the Data:

Anonymized images, CRF, and clinical interpretation must be transferred by the imaging site

directly to the QA labs. For security purposes please transfer all data using the designated

transfer method, and ensure that it has been anonymized properly.

Anonymized Images Direct DICOM – Transfer between preconfigured DICOM nodes of the imaging site and

QA lab. This solution is most likely only applicable for data transfer within the same

institution.

FTPS – Upload to a QA lab’s secure FTP site (instructions included in SOP site FTP

Instructions.docx).

Clinical Interpretation Report & CRF(s) Attachment via APA Web – follow the instruction in above.

FTP – Upload to a QA lab’s FTP site (instructions included in SOP site FTP

Instructions.docx).

FAX – fax the clinical interpretation reports & CRF(s) to the QA lab.

FTP Account information for each site is as follows:

Site Address Port Protocol Account Username*

UOHI ftp.ottawaheart.ca 22 SSH/SFTP IMAGEHF

Robarts aqnet001.imaging.robarts.ca 22 SSH/SFTP IMAGEHF

uAlberata files.med.ualberta.ca 22 SSH/SFTP ImageHF1

MHICC TBD TBD TBD TBD

* Passwords for FTP accounts can be obtained by contacting Ran Klein ([email protected])


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Feedback from QA Lab

Applies to all imaging modalities and respective QA CRFs.

A completed HF-QA CRF will be submitted to the imaging site from the QA lab using the web

portal. This report is intended as QA feedback to the interpreting physician. All the QA feedback

from the QA Lab can be obtained from the Work Queues tab. Please follow the steps below as

outlined:

1) Click on the Work Queues tab to show you the link to go to the QA form in the Recently

Used Work Queues tab, as shown below.

2) Select the desired HF_QA subject message you wish to open from a list of messages

that may appear, as shown below. Note: Recent messages received, normally found at

the top of the list, will be highlighted in bolder blue font color.

3) Click on the PDF form icon listed beside the desired HF_QA subject message to view

the QA-CRF in PDF format; and, click on either the link icon or the HF_QA subject

message itself to view the QA-CRF in html format, as shown below.


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QA Lab and Imaging Site Consensus Review If no interpretation disagreements are reported in the mandatory consensus fields, the

QA for this modality is completed.

If a disagreement is reported by the QA lab, the case will be automatically labeled for a

consensus review between the QA lab and imaging site. The procedure consists of:

1) The QA lab reviewers will contact the imaging site to schedule a time to review the

interpretation and reach a consensus.

2) Prepare all data relevant to interpretation for the consensus review.

3) The QA process will be completed by the QA lab after consensus is reached.

-END-

Documents

Data Transfer SOP – Imaging Sites