Complete the OncoDEEP Implementation Questionnaire

Optimise your laboratory’s CGP integration and build a plan using the OncoDEEP implementation questionnaire

To support your organisations journey towards implementing Comprehensive Genomic Profiling (CGP), we invite you to complete the OncoDEEP implementation questionnaire. This questionnaire is designed to assess all key areas necessary for planning, implementing, validating, and running the OncoDEEP kit within a clinical laboratory setting.

Why complete it?

This questionnaire will guide you through essential considerations, from initial setup to daily operations of the OncoDEEP kit. As a result of providing detailed answers, you’ll help OncoDNA to work with you to create a customized, step-by-step projectplan that addresses the specific needs and goals of CGP in your laboratory. The plan will cover:

Implementation readiness: Understanding your lab’s current setup and goals.
Validation protocols: Ensuring a smooth integration process.
Operational support: Tailoring training and ongoing assistance.

How it works

We understand that each organization is at a different stage in CGP adoption. The design of this questionnaire means you can leave questions blank if they are not applicable to your current setup. However, the more information you provide, the more accurate and helpful OncoDNA can make your implementation plan. After submitting your responses you can be sure that the relevant person will be in touch to organise a meeting and help you transition to use of the OncoDEEP kit.

CGP implementation questionnaire

Comprehensive Genomic Profiling (CGP)

a. Do you use an existing CGP solution?

Yes

If yes, which one?

If no, why are you looking at such a solution?

Strategic reasons for using CGP and the expected Benefits

a. What is the reason for using a CGP solution in your organisation? What particular cancer types and biomarkers are priority in your organisation?

b. If using an existing CGP solution what are the desired benefits of changing to another product? (TAT, reduced costs, less ‘hot spot tests’ etc)

c. If starting to use a CGP solution for the first time what are the desired benefits?

Mobilisation Planning

a. If using an existing CGP solution, do you have a plan to manage the transition to OncoDEEP kit?

Yes

b. If ‘yes’ what workstreams do you have in your project plan (list them)

c. If ‘no’ what workstreams do you want in your project plan (list them)

d. Who is responsible for forming the plan and managing the transition in your organisation?

Validation

a. Is the plan to use OncoDEEP (DNA only) or also add the RNA part?

b. What is your approach or has been your approach to validating the OncoDEEP kit? (‘light touch in house’/ validation based on a known methodology with a desire to publish the results/ outsource the validation based on a known methodology as no time ‘in house’)

c. If validating ‘in house’ who is responsible for this work in your organisation?

d. If currently validating the OncoDEEP kit, what have you validated to date and what is left to do?

Laboratory environment, equipment, and the vision for automation

a. Please describe the laboratory environment where you will run the OncoDEEP kit. Are the buildings new and purpose built or dispersed across multiple rooms in buildings soon to be retired?

b. What is your vision for automation? (please define your vision in a short sentence or paragraph illustrating how far you want to automate the workflow)

c. What sequencers and robotics do you have available to support the OncoDEEP workflow now?

d. Do you need to complete a local review of what equipment you have and what you might need in the future? (reflect on your definition of automation)

Laboratory workflows and test volumes

a. Do you have a ‘Standard Operating Procedure (SOP)’ or ‘Standard Protocol’ written to support the use of the OncoDEEP kit in your organisaiton?

Yes

b. If so, would you be willing to share it with other OncoDNA customers?

c. If not, would you like to receive an example of the SOP from other customers so you can modify it for your organisation?

d. If using the OncoDEEP kit (DNA only) do remember that if and when you choose to add in the ‘RNA’ kit that combined DNA and RNA workflow can be combined (the generic reagents will make life easy to use both solutions)?

e. What volume of testing are you currently expecting? E.g. x tests per week

f. What volume of testing are you wanting to achieve in the future? (e.g. this time next year) E.g. x tests per week?

Workforce and Training

a. What staff and grades are available to implement the OncoDEEP kit worflow?

i. Who is leading the change project (managing all aspects of the mobilisation plan)?
ii. Who is responsible for the 'day to day workflow' during the 'transition'?
iii. Who is responsible for the 'day to day workflow' when it is business as usual?

b. Do you have any current vacancies that impact on being able to transition to or continue to use the OncoDEEP kit?

Yes

No

c. Is there a training plan drafted?
i. What are the elements? E.g. theory training in relation to reagents, practical with support from OncoDNA's Field Application Specialists and Scientific team.
ii. How will the training be delivered?
iii. What is the plan for training updates overtime or for when new hires join your organisation?
iv. Who is responsible for training in your laboratory?

Quality Control and governance

a. How will your organisation ensure a stable quality standard 'run after run'?

b. Is there a desire to participate in European Quality Assessment Programmes?

c. Are you involved in any EQA schemes now and for what aspect of OncoDEEP (e.g. HRD)?

d. Who is responsible for EQA participation in your organisation?

e. How will you ensure a deep and continued knowledge of how the quality parameters for OncoDEEP work and communicate these with other parties (e.g. oncologists)?

Reporting

a. What is your required deliverable in terms of reporting the output of the OncoDEEP kit in your organisation? E.g. Build local reports using raw data from OncoKDM, or use report as issued from OncoKDM.

b. If not using reporting as issued from OncoKDM please outline why you are planning to build local reports.

Communicating the clinical benefits of CGP testing in oncology

a. What is the mechanism for sharing and informing oncologists/nurses/patients of your existing or future CGP solution (OncoDEEP)?

b. Do you have in place or plan to organise learning sessions for oncologists and nurses about OncoDEEP?

c. Do you have a patient leaflet on CGP outlining the benefits of such testing for patients to help educate them on how genomic testing can shape treatment and care?

Yes

No

d. Do you have any specific clinical projects planned? E.g. impact of HRD testing on clinical outcomes in ovarian cancer?

Yes

No

e. How do you plan to measure how the transition to OncoDEEP has resulted in improvement overtime. Do you have a 'benefits realisation' plan within your overall action plan?

f. What benefits could OncoDNA help you measure overtime? What help do you need from OncoDNA?

Implementation Timelines

a. Is there a training plan drafted?

Yes

No

b. What is the timeline to which you are working? (Please state your current position and the key deliverables you have for your organisation in relation to CGP in the next:

6 months

12 months

18 months

Already implemented

Support

OncoDNA provide Field Application Specialist (FAS) support 'on the ground' in laboratories to help transition to the OncoDEEP kit. As well as this there is a Scientific Support team which can provide input virtually via 'Teams' calls to suit the customer. Vurtual 'Tumour Boards' or Multi-Disciplinary Team (MDT) meetings can be enabled via our OncoKDM software.

a. What support do you need 'on the ground' and 'virtually' and at what frequency?

b. Is there a need for 'Tumour Boards or MDT meetings in your organisation?

Yes

No

Thank you for taking time to complete this questionnaire we believe this will help you to work more effectively and closely with OncoDNA's own teams so we can support you to optimise the use of OncoDEEP.

In your 1:1 the information in this questionnaire will be used to shape the conversation around the top three areas where you need support and help as weel as shape an overall action plan which OncoDNA will share with you a few days after the meeting.

In the meantime, when reflecting on your responses to this questionnaire please summarise your top three areas where help from OncoDNA Field Application Specialists and Scientific Support could add the most value to your organisation.

My top three areas where I need the most support

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