FACT Consulting Community Accelerator Survey

The FACT Consulting Community Accelerator program provides customized, peer-based, and hands-on education and support to community oncology programs providing or intending to provide immune effector cell (IEC) therapies, centered around FACT’s New Program Solution catalogue of quality management program documentation.

Please provide brief responses to the following questions.

FACT Consulting will review your responses and contact you to set up an interview. If your application is approved following the interview, you will be asked to review and sign an Engagement Agreement, participate in a kick-off meeting with a FACT Consultant, and complete milestone check-ins throughout the engagement.

If you have any questions about the Community Accelerator program or this application, please contact us at consulting@factglobal.org.

1.Institution name(Required.)

2.Institution physical address(Required.)

3.Institution website URL(Required.)

4.Contact person name(Required.)

5.Contact person phone number(Required.)

6.Contact person email address(Required.)

7.Clinical and strategic thinking in support of developing an IEC service offering.
Please describe your practice, how IEC services will be integrated, and why this effort is important to your practice, considering your envisioned patient volume, your special capabilities, and the importance of IEC services to the community you serve.
(Required.)

8.Planning or readiness of physical space.
Please describe your available or planned facility layout, including designated areas for patient care, treatment administration, IEC product storage, and administrative functions. If the facility is not yet available, please provide an expected timeline.(Required.)

9.Personnel.
Please describe your available or planned facility layout, including designated areas for patient care, treatment administration, IEC product storage, and administrative functions. If the facility is not yet available, please provide an expected timeline.(Required.)

10.Quality Management Program.
To what extent, if at all, have you begun developing a Quality Management Plan (QMP) or Quality Management System (QMS)?(Required.)

11.Policies, Procedures, and Documentation.
To what extent, if at all, have you begun developing standard operating procedures (SOPs), policies, forms, and other controlled documents required to support program operations?(Required.)

12.IEC treatment to be administered.
Which commercial IEC products are you currently authorized to administer, or are planning to become authorized to administer in the next ~18mos? Do you currently or plan to administer IECs under clinical research?(Required.)

13.Hospital collaboration for adverse event management.
Describe the hospital you envision working with to establish the critically important collaborative relationship for inpatient management of adverse events when necessary, including the hospital’s existing capabilities for blood cancer (leukemia and lymphoma), intensive care, and specialty support.(Required.)

14.Apheresis cell collection service.
Describe your plans for apheresis cell collection, including whether you intend to perform collection within your practice or outsource to an external apheresis service provider. If an external service provider is already identified, please describe whether the service will be provided on site or at a separate location.(Required.)

15.FACT accreditation.
Describe your anticipated timeline for applying for FACT accreditation. Community Accelerator recipients would ideally apply for accreditation within 18 months of award.(Required.)