What Do We Need to do to Meet Accreditation Requirements?
This question is frequently asked and for good reason. FACT-accredited blood and marrow transplant (BMT) programs that provide immune effector cellular (IEC) therapy must not only comply with the standards specific to IECs, but they must also apply all FACT Standards to their IEC programs as applicable. If just beginning IEC therapy, programs must be in compliance with the Standards as part of starting the new activity.
First, get to know yourself.
Ask the following questions:
- How many different IEC products are administered by our program? Are they industry-sponsored trials or investigator-initiated trials? Do we plan to administer licensed products?
- Who is responsible for infusing the IECs and treating the patient, and where is this physically performed (e.g., Do BMT attending physicians administer the products? Are the products administered on the BMT unit or elsewhere?).
- Who collects and manufactures the products? Is it collected in-house? Is it manufactured at an external company? Does the processing facility ever have control of the product?
- How is chain of custody established? Is an intermediary facility (e.g., hospital pharmacy, blood bank) ever involved?
- Are there any protocols established that include addressing issues related to IECs, including toxicities?
- Are physicians and staff trained in administering IECs, recognizing expected complications, and addressing adverse events?
- What data is collected, how is it managed, and how is it analyzed? What happens when an issue is detected?
- How is the IEC program integrated into the quality management (QM) program?
- Who is leading the IEC program? Is it the BMT Program Director or someone from a different service (such as leukemia)?
Second, talk to your Accreditation Coordinator at the FACT Office.
The value of the FACT Accreditation Coordinator cannot be overstated. With information gathered from the questions above, you can discuss your program’s model with the coordinator and determine next steps. Potential next steps may be:
- If preparing for a renewal inspection, submit all required documentation for immune effector cellular therapy in the Compliance Application and prepare for the inspection.
- If in the middle of the accreditation cycle, discuss your options. To receive an accreditation certificate for immune effector cellular therapy you must be inspected. You may choose to request an add-on inspection mid-cycle, or you may choose to wait until the renewal inspection.
- If completing the annual reporting process, report that you provide IEC therapy and attest whether you have reviewed the new standards and comply with them. Again, this will not result in IEC accreditation being listed on the FACT website as discussed above.
Third, perform a gap analysis of the Standards to determine compliance and correct any deficiencies.
Determine any gaps in compliance with the Standards. What processes need to be established, updated, or documented? Management of IEC products and their donors and recipients should become a routine part of the program; they will not be new to the program forever. There is no need to reinvent the wheel. In fact, establishing separate processes solely for IECs could put the program at risk for nonconformities and errors. Determine where the IEC program may need to be incorporated into existing processes, such as:
- Immediate access to drugs to treat cytokine release syndrome (note that this has been reported for haploidentical transplants and is not specific to IEC therapy),
- Nurse training (additional training modules may be required to train nurses as new therapies are provided), and
- Audits and outcome analysis (incorporate newly required audits and analyses into the existing schedule and perform them according to established procedures; remember that the analysis required at 30 days is required of all cellular therapies, not just IECs).
To be accredited for IEC therapy, programs must have mechanisms to comply with all standards related to toxicities even if they currently do not administer notably toxic IECs such as chimeric antigen receptor (CAR) T cells. For example, if a program only administers mesenchymal stromal cells (MSCs) for graft versus host disease (GVHD), which is not known to be as toxic, it still must provide staff training and develop policies for addressing known toxicities of a variety of IECs. This is to ensure transparency, credibility, and understanding of what FACT accreditation for IECs means. Due to the rapid growth in this area of cellular therapy, it is likely that programs will increasingly be adding new types of IECs to their repertoire. With this approach, not only will FACT accreditation remain clear and meaningful, accredited programs will be prepared to continue their ability to offer new therapies to patients.