FACT accreditation is a credential that has its greatest value in the peer-to-peer exchange of ideas to confirm and improve quality in patient care and laboratory services. Successful accreditation is awarded with two tangible items: an Accreditation Certificate and a final Accreditation Report. Although the certificate gets more prominence, often framed and mounted as a visual symbol of quality, the final report is a detailed accounting of what accredited programs implemented to reach compliance with all FACT Standards.
Each Accreditation Report provides important information related to an accredited program’s journey to initial or renewal accreditation. The final report includes:
- The name and location of the program
- The date of the on-site inspection
- The clinical, collection, processing, and/or banking sites and services associated with the accreditation
- Key personnel
- Identification of the FACT inspection team
- A description of the program
- Deficiencies and variances cited by the inspection team and approved by the Accreditation Committee
- Required responses to provide evidence of correction of each deficiency or acknowledgement of each variance
- The program’s responses documenting completion of corrective actions and compliance with Standards
- FACT’s response, or determination regarding the adequacy of the program’s corrective action
- Details of any additional follow up reports or documentation due to FACT
After completing the rigorous accreditation process, programs may debrief the contents of the Accreditation Report and then file it away, turning attention to its many other important duties until annual reporting is required. However, the final report is a valuable tool that can be used throughout the accreditation cycle.
Programs that have corrected deficiencies and submitted adequate evidence of correction and compliance with standards should be very proud of the work they have invested into improvement. Lessons learned throughout this process can be applied to the entire program. For example:
- How will we evaluate our corrective actions to confirm long-term effectiveness?
- What other strengths and weaknesses did we discover while correcting deficiencies?
- Are there further root cause analyses we should perform to prevent similar deficiencies?
- Can we apply the same process to evaluate other aspects of our program?
Ideas generated from this review of the Accreditation Report may be useful to maintaining the Quality Management program via audits, process development, personnel training, and other quality concepts.
External Confirmation of Quality
Apheresis collection facilities, cell processing facilities, and clinical services are each important in the context of blood and marrow transplantation, where accreditation covers the entire scope of the therapy from patient selection and treatment, through product selection, collection, processing, and administration. These same services participate in clinical trials often including products developed and manufactured by industry partners. These facilities recognize the importance of standards, have achieved voluntary FACT accreditation, and have played a major role in delivering new products to patients. They have used their quality programs and processes to quickly adapt to increasing numbers of products, procedures, and manufacturers. However, facilities have individually and collectively expressed concern regarding the growing number of on-site audits. The increased burden of preparing for, participating in, and responding to audits requires more resources to be diverted to these activities rather than toward patient care.
Commercial manufacturers who produce cellular therapy products for clinical trials or under an approved regulatory license may wish to leverage FACT accreditation to streamline audit activities, verify quality practices, and reduce the burden on health care entities. To do this, manufacturers may request a copy of the final FACT Accreditation Report. FACT does not provide Accreditation Reports to any entity except the accredited program. Accredited programs are not restricted from sharing these reports and may choose to provide them to manufacturers leveraging FACT accreditation, however, they are not required to do so.
Accredited programs or their hospital administration may be hesitant to disclose deficiencies cited during an on-site inspection. However, FACT accreditation is a voluntary, peer-based quality improvement process, during which some deficiencies can be expected at any program. The documented deficiencies demonstrate the rigor of the inspection process. The final report includes the description and documentation of the program’s corrective action, FACT’s determination of the adequacy of the response, and any additional follow up that may be indicated. Responses to deficiencies are an opportunity to proudly share a program’s process improvements. Programs should inquire of any commercial manufacturer regarding the confidentiality of information they provide to increase confidence in the use of the FACT report.
If a program chooses to provide the final Accreditation Report to a commercial manufacturer, it will likely be able to participate in an abbreviated site audit because the Accreditation Report can be used to confirm the quality systems in place meet FACT Standards. If a program chooses not to provide the report, it may be required to undergo a full site audit that will include requirements duplicative to the FACT Standards.
February 5, 2020
3:00 pm ET, 20:00 GMT
Join FACT for the final webinar in the ninth Quality Management Series, Auditing. Phillip Johnson, MMedSc(Path), Production Manager at Queensland Cord Blood Bank at the Mater, Sylvia Dulan, RN, MSN, MBA, PMP, HCT Regulatory and Quality Management Specialist at City of Hope Hematopoietic Cell Transplantation Program, and Ann Wilson, MHA, MT(ASCP)SB , Lab and Quality Manager at Scott & White Autologous Transplant Program, will give an overview of their program’s audit process and how they write audit reports.
The first three webinars within the module are available for download in the FACT store:
- QM Series 9: Auditing: Planning and Executing
- QM Series 9: Auditing: Summarizing and Evaluating the Data
- QM Series 9: Auditing: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors
Stay tuned for the next QM Series 10, Validations! Topics include Validation Overview, Process Validation, Software Validation, and Program Perspectives on Validation.
By Heather Conway, FACT Quality Manager
To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews each program’s most recent CIBMTR data audit results including implementation, adequacy, and effectiveness of the corrective action plan (CAP). The committee’s goal is to provide education and assistance to cellular therapy programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.
Since its inception, the committee has provided extensive guidance and assistance to programs regarding data management, audit, and quality improvement principles. Using this experience, the committee created a Data Management resources area to assist programs. Programs are encouraged to review this information, which contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.
The FACT-CIBMTR collaborative data audit process was formed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited transplant programs. The program intensifies support and improvement of data management and reporting processes, and these new resources support these efforts. In addition to the website, view previous newsletter articles about the program:
It has been a long time coming, but now it is official. Full implementation of ISBT 128 coding and labeling is required of cellular therapy programs.
ICCBBA released an ISBT 128 compliance audit tool for use with cellular therapy products. The tool provides a means of determining compliance with the ISBT 128 Standard, and can be used by any cellular therapy facility around the world. It includes both interactive and printable audit checklists. FACT recommends use of this tool to verify correct implementation of ISBT 128 and to verify ongoing compliance. It may also be useful as an educational reference.
It is important to note that the tool does not take into consideration requirements from national regulatory bodies and may not cover all labeling requirements of cellular therapy accreditation bodies. Additionally, the tool does not ensure that proper Product Codes have been selected. Rather, it verifies correct placement and format of complete information.
Although ICCBBA has made validation tools available in the past, this is the first time an audit tool has been released. Input was received from industry experts and the international Cellular Therapy Coding and Labeling Advisory Group that is co-sponsored by ICCBBA, AABB, FACT, ISCT, and others. An instructional video is available on the ICCBBA website at www.iccbba.org.
Many FACT-accredited cellular therapy programs participate in clinical trials, and awareness of such activities has become more pronounced with the advent of FACT’s new voluntary accreditation for immune effector cellular (IEC) therapy. Most IEC products are administered under Investigational New Drug, or IND, requirements.
There are some FACT requirements that are not typically required of INDs but could greatly enhance research, such as a quality management program, accessible procedures, and training. Likewise, some typical IND requirements could be used to also satisfy FACT requirements, and documentation created to comply with IND requirements can be used.
FACT requires outcome analysis, which is also performed in accordance with IND requirements. The program does not need to gather and report its own independent data if this is already performed by the investigator and shared with the program. This could be demonstrated through minutes from a quality meeting where outcomes were reviewed, or within signed outcome analysis reports. The key is that outcome information is reported back to the accredited center’s Quality Management (QM) program in some fashion to allow assessment of program performance (such as personnel training and competency or needed procedural improvements).
Product efficacy based on patient outcome may be difficult to document for novel cellular therapy products, and that assessment will differ for each product type. Predefined outcome criteria for investigational cellular therapy products (e.g., CAR T-cells, vaccines) may be found in the clinical research protocol and may include clinical outcomes or only safety endpoints, depending on the trial phase. Data from each investigational product does not need to be aggregated in total; for example, IECs vary widely in cell type, manipulation, protocol, and indication. However, data regarding similar products may shed important light on process improvements within the control and discretion of the program (protocols must be strictly followed per IND requirements).
Reporting of outcome data also advances the field. FACT Standards recommend that Clinical Programs collect each of the data elements contained in the applicable CIBMTR Cellular Therapy forms or EBMT forms. Use of the actual form and submission to CIBMTR or EBMT is not required unless dictated by applicable laws and regulations. FACT strongly recommends the publication of data and strongly encourages the submission of data to the CIBMTR. In the event that the Clinical Program does not submit data to these registries, it should provide reasonable explanations for not doing so. Examples of the forms currently utilized by the CIBMTR may be found on the organization’s website at http://www.cibmtr.org.
Similar to outcome analysis, audits are typically performed as directed by INDs and the results of those audits can satisfy FACT Standards if they are forwarded to the QM Program for review. If an IND does not require an audit, then an audit as required by the Standards must take place.
Policies and Procedures
Many programs utilize IND protocols to satisfy FACT requirements for SOPs. At a minimum, programs should have a local, high-level SOP that describes the big picture of the activities to perform. Actual protocols could be referenced and made available to staff, or the detailed procedural steps could be outlined in job-specific SOPs. Some manufacturers have very specific SOPs and provide them to programs, and, in these cases, there is no need to copy the SOP over to the program’s format. However, protocols are not a no-fail way of meeting the intent of the standard. Programs should ensure that the protocols include specific details for staff performance without being burdensomely long, that they are accessible to staff, and that training on the protocols has been performed.