FACT Accreditation

FACT Accreditation Program Voluntary Cellular therapy programs and cord blood banks choose to increase the quality of their processes for the benefit of patients Provides evidence of external validation for use in applications to funding organizations and collaborators in clinical trials Focused on improving patient outcomes; demonstrated improvements published Peer-driven Inspectors are peers who volunteer to serve Inspectors teach, coach, mentor, and learn from inspections International Promotes access to matched donors and quality cell products worldwide Accredited cellular therapy programs in 7 countries and expanding Accredited cord blood banks in 25 countries and expanding

FACT Accreditation – August 2017 Hematopoietic Cellular Therapy Programs US Australia Brazil Canada Mexico New Zealand Singapore Total 197 6 1 16 2 224 Cord Blood Banks (57 in 25 countries) URD Units Related / Family Both TOTAL US 5 1 4 10 Non-US 13 7 27 47 18 8 31 57

Stated Benefits from Accredited Facilities FACT accreditation required by some clinical trial groups and insurance companies Able to meet unique and diverse demands of several INDs Improved processes and morale Standardized processes increased efficiency Evidence of external validation helpful in obtaining grants and funding Adds to facility credibility in eyes of investigators Useful to application to participate in multi-institution trials Use in marketing and advertising for whole facility

Online Resources Cellular Therapy Library Cord Blood Bank Library CT guides and forms Cord Blood Bank Library CB guides and forms FACT Workshop and Webinar Calendar FACT Recorded Tutorials and Webinars Immune Effector Cell webpage Publications referencing FACT Educational recordings Standards and Accreditation Manuals Free download Print copies for purchase

Education

Education As an international accrediting organization, FACT educational events are intended to be worldwide. In 2016, FACT participated in sessions on five continents.

Location of FACT Events in 2016

Education FACT offers a variety of in-person workshops and online webinars FACT strives to provide education globally on the most current and relevant topics In the past five years, FACT hosted 28 all-day workshops and over 60 webinars to ensure that quality care is provided to patients

All upcoming educational events can be found on the FACT website (www All upcoming educational events can be found on the FACT website (www.factwebsite.org) under the Education and Resources tab You can also find additional education resources on this page (highlighted on right)

All on-demand educational webinars can be found on the FACT website (www.factwebsite.org) under the Store tab

Cost of Transplantation

Average Cost *Medical costs and resource utilization from date of transplant hospitalization to day 100 post-transplantation by age at transplantation <20 years 21–40 years 41–60 years >60 years Autologous HCT (total costs, median) $158,502 $106,929 $98,755 $87,374 Allogeneic HCT (total costs, median) $303,709 $202,962 $192,228 $155,548 Jean- Below is the abstract from the journal that the above information was taken from. There is a lack of multi-center cost-identification studies for hematopoietic cell transplantation (HCT). We used a single longitudinal administrative claims database representing a national, commercially insured population to evaluate the feasibility of identifying HCT recipients and to establish a cohort of autologous and allogeneic HCT recipients to study inpatient and outpatient direct medical costs from transplant hospitalization through first 100 days post-transplantation. Using ICD-9 procedure and diagnosis codes, we identified 3365 patients who had received their first transplant in the United States between 2007 and 2009 (autologous, 1678, allogeneic, 1320, graft source not specified, 367). The median 100-day total costs for autologous HCT were $99 899 (interquartile range (IQR), $73 914–140 555), and for allogeneic HCT were $203 026 (IQR, $141 742–316 426). The majority of costs (475%) occurred during the initial transplant hospitalization for both autologous and allogeneic HCT recipients. Costs were greater among pediatric (p20 years) compared with adult (420 years) recipients and this difference was more pronounced with allogeneic HCT. Using a claims database representing a national HCT population, we highlight the high costs associated with autologous and allogeneic HCT. Our study lays the foundation for using claims data for future research on economic aspects of HCT. *Majhail, NS., Mau, LW., Denzen, EM., Arneson, TJ. (2013). Costs of autologous and allogeneic hematopoietic cell transplantation in the United States: a study using a large National Private Claims Database. Bone Marrow Transplantation, 48, 294-300. doi:10.1038/bmt.2012.133

Investment Costs can vary from state to state, and areas where transplants are in high-demand will see higher prices This is a heavy investment for insurance companies Insurance companies need reassurance that they are getting good outcomes for the investment

Payers and Providers FACT centers have a reputation as centers of excellence that exert adequate quality control over the entire HCT process. Many payers and providers do not recognize non-FACT accredited centers in the USA as experienced centers with fully developed clinical treatment protocols. FACT accreditation is becoming required for patient care reimbursement from many government agencies. Most insurance companies require HCT programs to disclose FACT accreditation status as part of the application for Center of Excellence designation. Many insurers and National Transplant Networks include FACT accreditation as a requirement for selection/inclusion.

Patient Care Patients seek FACT-accredited programs when looking for a quality patient care and treatment program International clients seeking quality cellular products rely on adherence to known standards and accreditation, as found in FACT accredited programs FACT accreditation is required by some cancer trial groups FACT accreditation is required of blood and marrow transplant programs that participate in the Cancer Trials Support Unit of the National Cancer, the Children’s Oncology Group, the Eastern Cooperating Oncology Group, and the Southwestern Oncology Group

Survey of Transplant Programs: Positive Impact of FACT Accreditation The following were identified as having been positively impacted: Peer perception Attitude of the affiliated institutions towards the program Insurance reimbursement Number of transplants performed Participation in clinical trials FACT conducted a survey with HPC transplant programs who have maintained continuous FACT accreditation for ten years to assess the impact the accreditation has had on their programs. (It is important to note that FACT does not have the specific data to back these numbers up; the programs completed a simple rating scale.) Forman, S.J., Negrin, R.S, Antin, J.S., Appelbaum, F.R. (2016). Thomas’ Hematopoietic Cell Transplantation (5th edition)

Survey of HPC Programs with 10 Years of Continuous Accreditation For each of the categories, programs were asked to indicate whether FACT accreditation had a positive, negative, or neutral impact. As evident from the chart, responses stated overwhelmingly that FACT had a positive impact on many factors.

U.S. News & World Report FACT accreditation is a factor in the ranking of ‘America’s Best Hospitals,’ and ‘America’s Best Children’s Hospitals,’ published annually by US News and World Report. Since 2007, accredited programs receive points based on their accreditation. In 2017-2018, one point was given if accreditation was only for autologous transplants, and two points were given if accreditation was for allogeneic transplants. All 50 hospitals with rankings in the cancer specialty have programs that are FACT-accredited.

In Conclusion: FACT’s goals are to promote quality patient care and laboratory practices, improve treatment outcomes, and foster continued development of the field through Standards, Accreditation, and Education. FACT Standards are evidence-based written by world-renown experts in the field. FACT Standards include HCT, Cord Blood, Common, and Immune Effector Cells. FACT strives to provide education globally including, workshops, webinars, and publications. Many health insurance plans and managed care organizations use FACT accreditation as a factor for designating “Centers of Excellence.” FACT accreditation is becoming required for patient care reimbursement from many government agencies and health insurance companies. Patients seek FACT accredited programs when looking for a quality patient care and treatment program.

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