Just facts. Winter Board Updates FACT s Strategic Plan. Letter from the President

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1 Just facts t h e Winter 2014 Letter from the President FACT s story is one of phenomenal success. Many things come to mind when I m asked how this has come about, but there are three in particular. First, we have extraordinary volunteers. It s hard to imagine a more talented and dedicated pool of people who have donated their time to build the organization, serve on its Board of Directors, and lead and participate in its committees. And then there s our amazing inspectors. Every one of them is a volunteer, passionate about promoting high quality in cell therapy. Second, we have a remarkable staff in our Omaha headquarters. If you could visit that office, you d quickly recognize their skills and professionalism. And third, we ve disciplined ourselves with a series of strategic plans that have challenged us and kept us moving forward. At regular intervals we pause to recalibrate review what has been accomplished, assess upcoming needs, and set new goals. It s especially timely to say a few words about that third leg of our stool goals and strategies because this past fall our board along with representatives of our parent societies ISCT and ASBMT updated FACT s strategic plan. The highlights of the plan are reported elsewhere in this newsletter, and you ll want to take a look if you re interested in the directions we re headed. (continued on page 2) Board Updates FACT s Strategic Plan At regular intervals, the FACT Board of Directors renews the organization s goals and strategic plan. An update approved this past autumn emphasizes three areas: Quality outcomes Education Regenerative medicine We know that our core activity is maintaining cell therapy standards and accrediting programs that meet those standards, says President Helen Heslop, MD. But it s also important to keep moving forward with new initiatives to maintain momentum and relevancy. During the coming months we will be focusing on ways to include measurement of clinical outcomes in accreditation, expand in-service education opportunities for cell therapy personnel, and open new paths to quality enhancement in regenerative medicine, she says. Updates of the FACT strategic plan is a formal process that begins with a survey of the needs of the cell therapy field, followed by a Board of Directors retreat in which recent accomplishments are reviewed, needs evaluated, and goals established. Breakout groups work on tactics for accomplishing the goals. Staff is then charged with fine tuning the tactics and developing timelines and budgets for final approval by the board. (continued on page 3) In this Issue: Verifying Central Line Placement Informed Consent ISBT 128 Implementation Listing Related Cord Blood Units Annual Compliance Documents Requested Ask-A-Peer Service Editor: Kara Wacker, MBA, RAC Accreditation Report Two new cord blood banks earned initial accreditation and sixteen organizations received accreditation renewal during the fourth quarter of The complete list is in the report of accredited organizations. Cellular Therapy Programs 219 Programs Registered 198 Programs Accredited 21 Applications Pending Cord Blood Banks 64 Banks Registered 46 Banks Accredited 18 Applications Pending

2 From the President - Mission and Values (continued) Our board spent no small amount of time crafting an easy-to-articulate mission and a clear statement of our values. Here they are: Our mission the purpose of FACT and the reason we exist: To improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients. Our values what we believe to be the core of our being: A voluntary organization of practicing professionals is best positioned to improve patient care and foster development of the cell therapy field through quality standards and accreditation. It s our mission statement that keeps us focused on being the premier organization setting standards and awarding accreditation for cellular therapy, including transplant and regenerative medicine. It s our values statement that inspires us to be a dynamic, global organization that is responsive to an evolving field and the needs of patients. Sincerely, Helen Heslop, MD FACT and JACIE Preparing to Publish Draft 6th Edition of FACT-JACIE Standards The FACT-JACIE Standards Committee has been reviewing and updating the Cellular Therapy Standards based upon new publications, feedback from accredited organizations and inspectors, and common deficiencies and misunderstandings. The draft 6th edition is a reflection of the cellular therapy field in general: the basic requirements remain the same but new concepts are introduced based upon increasing knowledge of HPC transplants and growing research in cellular therapy. The draft will be available for public comment in April We encourage all clinical units, apheresis facilities, and laboratories to prepare to review the updated requirements, including those involved in the processing of more than minimally manipulated products or products used for regenerative medicine. At the time of publication for comment, a redlined document and specific requests for comments will be available. Get Connected with FACT via our LinkedIn Group! FACT s LinkedIn discussion group provides an excellent resource for generating discussions among cell therapy professionals worldwide. The health care and biotechnology industries are predominantly represented in our group, consisting of members in a variety of job functions, including Operations, Quality Assurance, Education, and Research. At nearly 500 members, this group is becoming a quick resource for a variety of cellular therapy related topics. Discussions include the latest updates from FACT, news from our accredited organizations, and important developments in the cellular therapy community. If you would like to be included in this fast-growing group, request to join today! FACT s Facebook Page Is Another Resource for Cellular Therapy Information Our Facebook page provides an informal route to obtain quick, timely information for accredited programs and cellular therapy news that may be of interest to members. The FACT Facebook page reflects the collegial personality within the FACT community. Sign up today! Winter

3 FACT s Updated Strategic Plan (continued) Quality outcomes Among the primary goals for the coming months will be including clinical outcomes and patient safety as factors in FACT standards and accreditation. It s readily acknowledged that FACT standards for quality assurance are based largely in clinical and laboratory processes and procedures. The questions that will be addressed by a special task force are: What valid and reliable metrics measure clinical outcomes and safety? Can those metrics be folded into clinical and laboratory standards and accreditation? Education The board members agreed that in-service education for cell therapy personnel is an important component in promoting quality, as surely as standards development and accreditation. In recent years, FACT has developed a comprehensive schedule of workshops, webinars, online tutorials, and publications that address a broad range of topics pertaining to standards, accreditation, and quality assurance. The strategic plan calls for wider visibility of and participation in these educational programs, with promotional outreach to transplant and regenerative medicine facilities and cord blood banks. Regenerative medicine A third priority is acceptance of FACT standards and accreditation throughout the field of regenerative medicine. To achieve this, FACT has developed a template of core standards and is working with professional organizations in the emerging fields of cell therapy (such as cardiology) to meet the needs of their programs and patients. Other initiatives In addition to the three priorities described above, the updated strategic plan has other specific goals and objectives: Making standards as clear and user-friendly as possible Assisting smaller cell therapy facilities that don t yet have the patient volume to qualify for accreditation Coordinating with other cellular therapy organizations on the evaluation of data management within transplant facilities Engaging third-party payors in ways that will enhance their understanding of FACT standards and accreditation Capturing and sharing information about clinical and laboratory best practices, as identified by the FACT inspectors Accelerating international support of, and participation in, FACT standards, accreditation, and education Providing cell therapy consulting services to transplant facilities and cord blood banks through a non-profit subsidiary corporation Seeking new sources of revenues and doubling FACT s financial reserves over the next five years The strategic plan is aggressive, but eminently practical and doable, says Linda Miller, FACT chief executive officer. The board has already created several task forces that are developing plans and timetables to accomplish our updated objectives. We welcome hearing from all qualified participants in the cell therapy field who want to volunteer to help FACT achieve these goals. 3 Winter 2014

4 ISBT 128 Implementation Planning Important Information to Know The 5th edition Cellular Therapy Standards and Cord Blood Standards require accredited organizations to have a plan for fully implementing ISBT 128 technology, including both coding and labeling. Many organizations have begun this process and we commend you for dedicating the vast time and resources required of this project to better identify and track cellular therapy products worldwide. The best resource for ISBT 128 updates and guidance is Not only is a wealth of information available, there is also an option on the home page to sign up for relevant newsletters. The following are some newsworthy items FACT-accredited organizations should keep in mind: ISBT 128 released guidance for handling products not labeled with an ISBT 128 identifier: Although a long term goal of several cellular therapy organizations is that all products be labeled with ISBT 128 identifiers, facilities will receive products without this identifier from entities collecting or distributing a product on an ad hoc basis or products that were collected and stored prior to implementation of ISBT 128. This guidance provides useful advice that may be incorporated into your ISBT 128 implementation plan. ISBT 128 terminology was modified to better reflect source and types of cells: Product classes were revised greatly, resulting in two subcategories that distinguish the original composition of the cells and the target cell population after processing. The term therapeutic cells was replaced in many cases. Furthermore, manipulations are now a category of attributes. FACT understands these changes are not trivial and require a transition period for labeling systems using the ISBT 128 database. However, product labels must be updated with the new terms immediately, and any new products or labeling systems must start with the new terms. See the Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions v4.31 and the Implementation Guide: Revised Cellular Therapy Terminology for more details. The draft 6th edition FACT-JACIE Cellular Therapy Standards will include an update that requires full implementation of ISBT 128. The Standards Committee believes that implementation plans already required under the 5th edition have prepared facilities for this update. However, the committee asks that accredited organizations be mindful of capital required to purchase and implement the information technology systems and hardware and provide public comments as appropriate. WMDA Urges the Proper Use of Unique Identifiers The WMDA S(P)EAR Committee recently reported an event in which incorrect unrelated donor cells were infused into a patient. Root cause analyses identified multiple errors: The donor ID number was incorrect on the work-up request submitted by the transplant center (the number was missing the alphabetical prefix) The donor ID was not required to be complete at the donor center (the center did not request the prefix but used a donor with the same numeric sequence, who actually had a different alphabetical prefix) Systems for checking multiple identifiers were not in place. The WMDA urges all registries, donor centers, and transplant centers to examine numbering systems to ensure that numbers are not duplicated, that multiple identifiers are checked at all stages, and that only full ID numbers are accepted in all communications and on products. Winter

5 Accreditation Coordinator Commentary - Informed Consent is More than a Form Shannon Walsh, BS, CCRP To donate or not to donate; all potential donors must explicitly answer this question at some point, but likely keep it in mind during all stages of the donation process. Informed consent is not just a document, but an ongoing process. This process is essential to protect the rights of the donor and to ensure that the decision remains voluntary at all times with sufficient understanding of what is expected of the donor. The seriousness and risks involved with HPC transplantation make informed consent crucial. Many allogeneic donors are eager and willing to donate; however, in the case of related donations, difficult situations may arise that may not be apparent to everyone involved. Confidentiality and protection of health information (i.e., preventing unwanted disclosure between family members), or the pressure of feeling one is obligated to donate for a family member, can create difficult decisions and may cause unintended coercion. FACT-JACIE Standards not only require that the donor be allowed to refuse at any time, but that the donor be given sufficient information to form an adequate understanding of the potential consequences of their decision to refuse. For example, after the recipient has begun chemotherapy treatment, it is imperative that the donation proceed as the patient would likely not survive without the donor cells. The donor has the right to understand the responsibility of how the decision to refuse could cause life-threatening consequences to the recipient. Donors are given this precautionary information because, up to the point of donation, it remains a voluntary decision whether or not to donate. Care must be taken not to add wording that would revoke this right upon beginning the preparative regimen. For example, it is not appropriate to tell a donor he/she has a right to refuse until initiation of the preparative regimen. Maintaining a balance between the rights of the donor and the well-being of the recipient is essential for obtaining informed consent and will also help donors make a fully informed decision. Function and Safety Both Contribute to Adequacy of Central Line Placement FACT-JACIE Standard C8.7.1 requires that the adequacy of line placement be verified when central venous catheters are used to collect cellular therapy products. Line placement obviously affects the function of the central line, but the other intent of Standard C8.7.1 is to protect the safety of the cell donor. The Standards and Accreditation Committees have been deliberating the current interpretation of this standard to require verification via imaging (ultrasound, fluoroscopy, radiography, etc.). Use of blood draws to verify line placement can certainly be used to test function. But is it enough to verify that the line is placed in its intended location and not presenting a danger to donor health? What about femoral or inguinal lines? While there is a wealth of literature about prevention of infections caused by central venous catheters, few guidelines regarding verification of line placement exist. One good resource are the Practice Guidelines for Central Venous Access, reported by the American Society of Anesthesiologists Task Force on Central Venous Access. Based on the expertise and experience of the global Standards and Accreditation Committees, the intent of the standard remains the same: verification of adequate line placement must be performed using imaging techniques no matter what vein is used. Concerns related to radiation exposure can be minimized by using methods other than X-ray, such as ultrasound. FACT welcomes comments regarding the necessity of imaging during the 6th edition FACT-JACIE Standards public comment period, especially those referencing published literature and data. 5 Winter 2014

6 What It Means to List Unrelated and Related Cord Blood Units The NetCord-FACT Cord Blood Standards are the most comprehensive set of cord blood banking requirements, encompassing every step of the process from donor recruitment to release for administration. In the middle of the complex life cycle of a cord blood unit is the listing step. What this term means, and how it relates to unrelated versus related cord blood units, is a common question asked by cord blood banks. The English language has several definitions for the word list. As a noun, it means a series of like items written consecutively, as in a list of available units on a cord blood unit registry. Some definitions even use the word register. However, as a verb, to list means, among other things, to categorize similar items. This is how listing is defined in the NetCord FACT Standards: The process of transferring information about a cord blood unit to be available for search. Therefore, listing a unit does not necessarily mean that a unit is added to a registry, although that is a critical step of listing for unrelated cord blood units. Listing means that the cord blood bank must have a process for reviewing cord blood unit records to determine whether a unit should be considered for future clinical use, i.e., it is categorized as available for search. The following are some examples of standards related to listing, with an example of how each standard may be applied to both unrelated and related units. Although this is not an exhaustive list of all applicable standards, it illustrates how a bank might interpret the requirements. Standard Unrelated Units Related Units B1.4 The CBB shall have a mechanism to list and distribute CB units for clinical use. B Key functions (to be audited) shall include... listing... B Criteria for qualification and listing of CB units available for search and administration. Appendix III: Required Testing on CB Samples Any Time Prior to Listing The bank may choose to list the The bank may choose to retain only units acceptable unit on an international, national, or for clinical use, or retain all units but distinguish local registry or maintain its own list between those suitable for clinical use versus those and field all search inquiries. suitable for research or quality control. Banks must also be able to distinguish between units that have met release criteria and those that are still undergoing manufacturing steps, such as collection or processing. The bank must audit its listing process, which includes whether or not a complete record review is performed prior to making a unit available for search and whether all required information necessary for a clinician to select a unit is available and accurate. The bank must have criteria for The bank must have criteria for making a unit available making a unit available for search to a requesting physician for clinical use. for clinical use via a registry or in its own database. The bank must perform the tests The bank must perform the tests listed in this column listed in this column of the appendix of the appendix before the unit is available to a before the unit is listed on a registry requesting physician for clinical use. or becomes available for search via its own database. *These are simply examples. Banks must determine whether or not an action is in compliance with the Standards based upon their unique characteristics. Winter

7 FACT Volunteers Asked to Provide Annual Update to Statements of Compliance Each year, all FACT Board members, committee members, inspectors, and other volunteers must review and update certain information to keep FACT records current. FACT distributes a notification each year when this process must be performed. The initial request was distributed to all volunteers via and online updates are due by April 7, The Annual Compliance process is completely online to enable efficient completion. Follow the steps outlined on the Annual Compliance webpage to update your information. The process should take approximately 30 minutes to complete plus time needed to locate any needed documents (for example, medical licenses that were reissued within the past year). Inspectors are reminded that they must also participate in one educational activity per calendar year (workshop, webinar, tutorial, or inspector test). Inspectors can use the educational calendar to find sessions that would benefit their inspection skills. FACT periodically reviews inspectors participation and contacts those with any outstanding requirements. Cord Blood Survey Working Group to Begin Reviewing Responses In August 2013, FACT and NMDP spearheaded an inter-organizational survey to solicit information from transplant centers about their processes for confirming the identity of cord blood units received for transplant and preparing them for administration. Transplant centers responded to this request for information constructively, resulting in 77 completed surveys from around the world. Each of the participating organizations has appointed a representative to serve on a working group to review the responses and determine what course of action, if any, can be taken with the data. This may include guidelines, publications, or other educational initiatives. Feedback about the transplant community s needs regarding the identification and preparation of cord blood units can be sent to the FACT office at fact@unmc.edu. New Success Story Published on the FACT Website MD Anderson Cancer Center is the latest accredited organization to be featured in FACT s online list of Accreditation Success Stories. M. D. Anderson Cancer Center is recognized as No. 1 in cancer care in U.S. News & World Report s annual America s Best Hospitals survey, is Magnet credentialed with recognized nursing excellence, and is recognized by the National Marrow Donor Program (NMDP) as a specialized center for matched unrelated donor transplants. Read more about lessons MD Anderson Cancer Center has learned via the FACT accreditation process. FDA Publishes Updated Guidance Documents for Cord Blood The FDA published two final guidance documents for unrelated, minimally manipulated cord blood units. Both documents replace the term HPC-C with HPC, Cord Blood and expand the clinical indication. The Guidance for Industry: BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System also clarifies the types of clinical information that should be submitted for review, and adds additional references to other guidance documents on process validation and methods validation. The Guidance for Industry and FDA Staff: IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System clarifies the applicability of the requirement for a table of contents in the IND submission 7 Winter 2014

8 Transition to Online Accreditation Ramona Repaczki-Jones, MSE FACTWeb Launches Annual Report and Renewal Application Module FACTWeb s online Annual Report and Renewal Application module marks FACT s move to a completely online accreditation process. The FACTWeb accreditation portal has been live for 20 months and hundreds of applications have been submitted, evaluated, and inspected using the online system. The Annual Report is completed by accredited organizations one year past their accreditation date. At the time of accreditation, organizations may have been asked to supply additional information to ensure ongoing compliance with FACT Standards. This information will be included in the annual report. The Renewal Application is initiated one year prior to the accreditation expiration date. The information submitted allows FACT to create a personalized Compliance Application for the organization s next cycle of FACT accreditation and monitor continued compliance with the FACT Standards. Promising New Year Brings FACTWeb Upgrades: The Documents tab in the Compliance Application has new submenus to allow FACT inspectors to quickly navigate the documents submitted in the application and Review Notes. Applicants have access to the Document Library to upload or delete files and view their accreditation letters and reports. The Applications Summary page displays at-a-glance information for each Compliance Application such as deadlines, cycle number, application history, current accreditation letter, and report. All future Compliance Applications will be displayed on this page, allowing applicants and assigned inspectors to view previous applications. Past reports from the paper-based process are available in the Reference Center located at the bottom of this page. Requirements for applicant signatures were modified to require only one signature (from either the primary or alternate contact) when returning an RFI-ed application to FACT. On the Compliance Application Status View, there is now a floating menu that contains the following items: Print Checklist, Back to Sites, and Summary View. When selecting individuals to include in an application (such as the directors), the system will now automatically display all individuals from the organization as soon as the Select Individual button is clicked. Considerable effort has been taken to improve system performance, resulting in the following new features: Navigation using new tab openings: Upon the selection of certain functions in FACTWeb, a new tab in your internet window will automatically be created. Horizontal radio buttons: Questions on the Compliance Application requiring a yes or no answer now list the radio buttons horizontally instead of vertically to shorten the application screen and reduce scrolling. Starting with the 5th edition Cord Blood Standards and version 5.3 of the Cellular Therapy Standards, some standards have been added as checklist options to their parent standard. Each substandard is labeled with the standard number for clarity. See the FACTWeb Guide and Tips webpage for more helpful information! Winter

9 Choosing the Most Advantageous Browser for FACTWeb The FACTWeb accreditation portal is a web-based system in which display and functionality are highly dependent on the internet browser used. To ensure the best interface with FACTWeb, FACT recommends that applicants and inspectors use the Chrome browser, available for free download. Internet Explorer (IE) browser users should note that FACTWeb no longer supports IE 7. Users will need to upgrade to a newer version to successfully use the online accreditation portal. Some organizations information technology (IT) departments do not allow users to download internet browsers on their computers. In this case, we recommend users to contact the IT department and ask for approval and assistance with downloading Chrome because of its ability to improve FACTWeb performance, including document uploads and navigation. FACT also recommends that users manually clear browser caches to ensure the best online experience accessing the FACT website and the FACTWeb accreditation portal. Instructions on how to clear the cache in the various browsers are listed on the FACTWeb Guide and Tips webpage. Have a question? Ask-A-Peer! The Ask-A-Peer service provides assistance to organizations seeking initial FACT accreditation or to new personnel at currently FACT-accredited organizations. It is intended to facilitate collegial interaction between individuals seeking advice and experienced professionals from FACT-accredited organizations. Peer Advisory Panel The Peer Advisors will provide brief guidance on organizing and preparing for an inspection to those seeking assistance, suggestions, and guidance. The Peer Advisory Panel is comprised of experienced personnel from FACT accredited organizations, FACT Inspectors, and FACT committee members. Ask-A-Peer is Educational Ask questions of your peers online, such as: How do you prepare for FACT accreditation? How do you demonstrate compliance with specific standards? What are your strategies for a successful on-site inspection? How do you respond to citations? Should a copy of all records regarding maternal and infant donor be stored at the collection site and cord blood bank administration area? What is the best way to give my facility a complete audit to ensure everything is in order? Ask-A-Peer Process Submit your questions using the Ask-A-Peer icon at 9 Winter 2014

10 Congratulations to our new inspectors! Ahmad Al-Homsi, MD; Spectrum Health Blood and Marrow Transplant Program Allen Chen, MD; The John Hopkins Bone Marrow Transplantation Program Jose Da Silva, PhD; The Cell Manufacturing Program Laboratory at the University of Miami Diane Fournier, PhD; Héma-Québec Adam Gassas, MD, MBChB, MSc, MRCP, DCH; The Hospital for Sick Children Blood & Marrow Transplant Program Patrick Hanley, PhD; Children s National Medical Center Blood and Marrow Transplant Program Stephanie Jacobson, FNP-C, OCN; The Blood and Marrow Transplant Group of Georgia at Northside Hospital Elias Kalouche, MBA, BSc, MLT(CSMLS); Insception Lifebank Cord Blood Program, Insception Biosciences Rebekah Knight, BSc; Northwest Marrow Transplant Program Nicole Prokopishyn, PhD; Alberta Blood and Marrow Transplant Program Arun Prasath Shanmugam; Singapore Cord Blood Bank Melhem Solh, MD; Florida Center for Cellular Therapy (FCCT) Karl Stasko, MPH; Dana Farber Cancer Institute / Cell Manipulation Core Facility Amir Steinberg, MD, FACP; Mount Sinai Bone Marrow and Stem Cell Transplantation Program Organizations whose personnel serve as FACT inspectors typically have better inspection results due to increased understanding of FACT requirements and lessons learned from other accredited organizations. We encourage you and your colleagues to apply to become inspectors. Attend a FACT Educational Event! The events below are open for online registration. Check the online calendar regularly for updated sessions. Date Title Location Meeting Content March 21 April 2 April 23 April 23 April 23 April 25 May 19 June 7 June 8 Winter ASBMT and NMDP Resources for Educating Clinical Teams Cellular Therapy Collection Workshop Inspection & Accreditation Workshop for Cellular Therapy and Cord Blood Banking Cellular Therapy Leadership Course Advanced Cellular Therapy Leadership Course FACTWeb User Session at ISCT Personnel Training, Competency, and Education Virtual Roundtable FACTWeb User Session at CB Symposium Cord Blood Inspection & Accreditation Workshop Online San Francisco, California Paris, France Online San Francisco, California QM Series Module 4: Personnel ASFA Annual Meeting ISCT Annual Meeting QM Series Module 4: Personnel International Cord Blood Symposium Discover resources for maintaining clinical certifications and competency Participate in discussions and activities focused on successfully navigating the inspection and accreditation process Gain understanding of the FACT accreditation process and Standards Improve your leadership skills in cellular therapy. Advance your organizational development skills. Learn more about FACTWeb and view demonstration Listen to accredited organizations share their methods for delivering personnel training and maintaining competency Learn more about FACTWeb and view demonstration Participate in discussions and activities focused on successfully navigating the inspection and accreditation process