Cord blood banking accreditation is an important method for maintaining an inventory of cord blood units suitable for transplantation and other clinical trials. Given the increase in patient diversity, expansion protocols, indications, and financial pressure, the quality of cord blood units is as important as ever. My own institution has received cord blood units from FACT-accredited and non-accredited cord blood banks for transplant, and the differences in quality of labeling, documentation, shipping, and the products themselves is evident. All cord blood banks, whether public, private, or hybrid, are encouraged to pursue FACT accreditation for patient safety. Not only will recipients of cord blood units benefit, but banks themselves will benefit from a stronger financial position based on an inventory of quality, usable units. This newsletter includes several articles related to cord blood banking, demonstrating the benefits of FACT accreditation.
Another notable article is a tribute to Michael Lill, MD. We will sorely miss Michael’s intellect, kindness, sense of humor, and progressive thinking. He regularly identified ways in which FACT could expand and improve its services for our stakeholders, and we all benefit from his contributions.
FACT has benefited from the expertise and counsel of many more individuals, including Nancy H. Collins, PhD. I congratulate Nancy as the recipient of this year’s ISCT Career Achievement in Cellular Therapy award. It is much deserved.
By Dennis Gastineau, MD, FACT President
We all lost a friend on June 19. Born and educated in Australia, Dr. Michael Lill endured many struggles with cancer, yet he rarely allowed any interferences with his mission of helping patients, colleagues, and friends.
A quietly cheerful man, Michael took on hard tasks, shepherding people through cancer treatment without transfusion, attending to bone marrow transplant patients, leading the Cedars-Sinai Blood and Marrow Transplant program, and helping the larger BMT community through his many roles in the Foundation for the Accreditation of Cellular Therapy (FACT). “Michael was a kind, intelligent, and dedicated physician,” says Dr. Elizabeth Shpall, who worked with Michael frequently on important initiatives in the field. “He was a huge asset to FACT and ASBMT with an amazing heart.”
Michael was the Director of the Blood and Marrow Transplant Program at Cedars-Sinai Medical Center and a Professor of Medicine at the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center. Dr. Lill’s research and clinical interests focused on bone marrow, peripheral blood and cord blood stem cell transplantation, leukemia, lymphoma, myeloma and MDS. He is known for developing a program in bloodless transplantation for Jehovah’s Witnesses. Dr. Lill was listed as one of the “Best Doctors in America,” as well as one of the “Best Cancer Doctors in America” from 2005 until the present. He served on several national transplant related committees, and held a long-standing interest in the ethical and philosophical aspects of religion and its intersection with medical practice.
Our Past President, Dr. Helen Heslop, knew that Michael was effective in any task he undertook, “When I was FACT President, Michael was a ‘go to’ person for leading new initiatives because of his broad knowledge, his commitment to quality and providing the best care for patients, and his leadership skills.”
Michael was the first Chair of our Clinical Outcomes Improvement Committee, and was instrumental in establishing new requirements for evaluating and improving one-year transplant survival. He led us to find our form and function, to better understand what programs need to do to improve their care of patients, and to become a committee consistently guiding programs through self-evaluation and improving care of their patients. “Michael was a transformational leader in the evaluation of outcomes,” says Chief Medical Officer, Dr. Phyllis Warkentin. “He was patient, and he provided a voice of reason that was pivotal to establishing a fair process for reviewing programs’ plans for improving survival.”
Dr. Fred LeMaistre, who served as Co-Chair of the Outcomes Committee with Michael, says, “Michael played so many roles for so many of us. Friend, colleague, mentor, leader are all inadequate descriptions. An immeasurable loss for us, our field and the patients we serve. A void now exists in our world that will not soon be filled.” Dr. LeMaistre now chairs the committee and frequently encourages us to utilize Michael’s advice during committee deliberations.
Another FACT Board member, Dr. Catherine Bollard, reflects on Michael as both colleague and friend. “Michael was a true gentleman and had the kindest of spirits while at the same time having an endearingly wicked sense of humor. Michael was a rare individual by so many metrics. His contributions to the transplant field and especially his critical work within FACT are significant and will be an enduring legacy. His was a life that was cut short way too soon and he will be truly missed.”
“A soft-spoken gentle man, Michael was a philosopher and quintessential writer,” said Linda Miller, FACT’s Chief Executive Officer. “His poignant blog provided everyone with insight to a more introspective side, reflective of his focus on the positive aspects of those things that brought him joy – his wife, family, dog, garden, and oh yes, wine.”
We have lost a beacon. We were all privileged to have known him, and to honor him we must carry on in the manner of Michael—being strong, gentle, erudite, and most of all, caring.
Michael Lill – FACT Leadership
FACT, Board Member 2013 – 2017
FACT, Treasurer 2016 – 2017
Chair, FACT Clinical Outcomes Improvement Committee 2013 – 2017
FACT Inspector for nearly 20 years performing 20 clinical and laboratory inspections
A comparison of cord blood banking standards and voluntary accreditations has been completed by the Cord Blood Association (CBA) Quality Standards Committee.
The committee’s report is the result of an extensive review and analysis of banking standards, as well as questions posed to AABB and the Foundation for the Accreditation of Cellular Therapy (FACT). The report compares:
- ways in which the standards are identical, similar and different
- each agency’s standards development process
- methods by which compliance is determined and inspections conducted
The study was requested by the CBA Board of Directors to assist banks that are seeking either or both accreditations.
“FACT accreditation is the pinnacle of quality in cord blood banking,” states Dennis Gastineau, MD, FACT President. “This prestigious accreditation is trusted by physicians and families using cord blood as a life saving therapy.” FACT cord blood accreditation is:
- a valid and reliable method for measuring excellence in cord blood banking services
- a means for banks to demonstrate their excellence to donors, parents, patients, and transplant physicians
- internationally recognized among peers for competence in supporting life-saving and life-enhancing therapies
- an avenue for increased financial strength through market share and revenue growth
During its 2018 Annual Meeting in Montréal, the International Society for Cell and Gene Therapy (ISCT) bestowed the Career Achievement Award in Cellular Therapy to Nancy H. Collins, PhD. Recipients of this award are individuals who have made a significant impact during a career devoted to advancing the field of cellular therapy.
In a tribute to Dr. Collins in the ISCT Telegraft, Carolyn A. Keever-Taylor, PhD, wrote, “Nancy is well-suited for this award as illustrated by her many contributions to the field of cellular therapy, from the early days of bone marrow transplantation where she literally defined the role of Laboratory Facility Director, through to the present.” Dr. Taylor described Dr. Collins’s role in founding FACT, “Nancy played a major role in the creation of FACT, which was jointly founded by ISCT and ASBMT to be an independent body that would complete development of laboratory and clinical standards. Here too she was a founding member of the FACT Board of Directors. Nancy was instrumental in recruiting individuals from other cell processing laboratories to be actively involved in these efforts.”
FACT is incredibly grateful to Dr. Collins for the guidance, leadership, and friendship she has generously provided to inspectors, committees, and staff. The following is a list of Dr. Collins’s impressive contributions to the organization:
- Founding member of the Foundation for the Accreditation of Cellular Therapy (1995)
- Board of Directors (1996-2009), 14 years
- Inspector (1996-2015), 19 years
- Cellular therapy laboratory inspector, 19 years
- FACT-NetCord cord blood bank laboratory inspector, 16 years
- More than minimal manipulation inspector, 3 years
- Standards Development (2000-2011), 11 years
- Cellular Therapy and Cord Blood Standards committees, served as member or co-chair
- Overall chair of the 4th edition of both Cellular Therapy and Cord Blood Standards
- FACT Inspector and Facility Training Workshop presenter (multiple)
- FACT Cellular Therapy Accreditation Committee (1995-2015)
- FACT Cord Blood Accreditation Committee (2006-2015)
- FACT Quality Management Committee and Quality Handbook Committee (2008-present)
- FACT representative to multi-institutional Circular of Information for the Use of Cellular Therapy Products Committee (2007-2014)
- Consultant, FACT Consulting Services (2015-present)
Congratulations, Nancy, on this well-deserved honor!
The United States Food and Drug Administration (FDA) released six draft guidance documents related to gene therapy. Three of the guidance documents are disease-specific, and three are related to manufacturing. According to Scott Gottlieb, MD, FDA Commissioner, these documents are the building blocks of the FDA’s framework for advancing gene therapy while requiring safety and effectiveness. The guidance is part of the FDA’s efforts to provide clear recommendations to sponsors and researchers.
The FDA highlights the importance of establishing standardized procedures for cell collection and handling across all collection sites for multi-center clinical trials to assure the quality and safety of the final product as well as ensuring control of the manufacturing process. A list of collection sites, the FDA Establishment Identifier, and accreditations for compliance with established standards (e.g., Foundation for the Accreditation of Cellular Therapy) should be included in the IND.
Additional Manufacturing Draft Guidance Documents
Disease-Specific Draft Guidance Documents
FACT-accredited organizations are regulated by several governmental agencies around the world in relation to quality and safety of cellular therapy products and reimbursement. When draft regulations or guidance documents are released, FACT committees review the information and submit comments as applicable to the scope of FACT accreditation. In the past decade, comments have been submitted to agencies in the United States, Australia, and Europe. The FACT Global Affairs Committee also supports cellular therapy leaders in developing countries to encourage use of FACT Standards.
So far this year, FACT has submitted comments on three topics to two agencies in the United States:
- Docket No. FDA-2017-D-6154 for “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry”; submitted to the Food and Drug Administration (FDA) on February 9, 2018.
- Docket No. FDA-2017-D-6159 for “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry”; submitted to the Food and Drug Administration (FDA) on February 9, 2018.
- National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers; submitted to the Centers for Medicare & Medicaid Services on June 15, 2018.
FACT also plans to review the recently published FDA draft guidance documents for gene therapies. These comments are due by October 10, 2018. If you have input you would like FACT to consider for inclusion, submit those to Kara Wacker at email@example.com by August 31, 2018.
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:
The U.S. News & World Report released the 2018-19 Best Hospitals and Best Children’s Hospitals rankings. The rankings help patients and their families find medical care.
FACT accreditation is used as a criterion that represents high-quality, hospital-based care in the cancer specialty. For the Best Hospitals list, one point was given if a hospital is accredited for autologous transplantation, and two points were given if a program is accredited for both allogeneic and autologous transplantation. For the Best Children’s Hospitals list, a hospital was awarded one point if it was accredited by FACT as a pediatric or adult service provider for either autologous or allogeneic transplants. Congratulations to these hospitals!
By Cassandra Kennedy, Accreditation Coordinator
The Cord Blood Accreditation Committee reviews inspection reports under the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and makes recommendations to the FACT Board of Directors regarding accreditation status. This committee includes 14 committee members who are experts in the field and are experienced in cord blood banking, collection, and/or processing.
The committee conducts regularly-scheduled meetings to review inspection reports for renewal accreditation. A commonly cited topic within recent inspection reports is assessment of hemodilution (i.e., B3.1.18, C3.1.14, and D2.1.6). Cord blood banks must ensure there is a description of the process for assessing hemodilution and that there are established acceptance levels. For more information on common Cord Blood Bank citations, FACT encourages you to register for the WMDA-NetCord & FACT Cord Blood Day on September 14, 2018.
By Cathy Talmadge, FACT Accreditation Services Supervisor
Cord blood collection sites are selected for inspection based on specific variables in order to evaluate compliance with the NetCord-FACT Standards. Cord blood banks should be aware that sites they consider to be “non-fixed” may be inspected during the next FACT inspection depending on the site’s ongoing responsibilities and number of collections performed.
In order to prevent issues upon scheduling the inspection, FACT recommends that cord blood banks inform their non-fixed collection sites that an on-site FACT inspection may occur. The following information may be helpful to non-fixed collection sites who are unfamiliar with FACT accreditation and processes:
- The mission of FACT is to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients. WMDA-NetCord’s mission is to support, promote, and enhance safety, efficacy, and availability of international exchange of cord blood units and to harmonize global practice of cord blood banking and supply. Accreditation is achieved by demonstration of compliance with the current edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration (the “Standards”). The Standards have been developed to promote quality medical and laboratory practices throughout all phases of cord blood collection, banking, and release for administration to achieve consistent production of quality placental and umbilical cord blood units for administration. They are developed by world-renowned experts in the field including clinicians, collection professionals, laboratory scientists, technologists, and quality experts. The Standards are based on published medical literature, when available, and accepted scientific theory and expert consensus. The Standards define minimum requirements to reach a level of quality worthy of accreditation and allows flexibility in methods/processes to meet requirements.
- To be eligible for accreditation, a cord blood bank must have processes in place to meet all of the Standards, whether the activities are performed internally or by contract with another facility. The inspection and accreditation process is summarized on the FACT website and includes an on-site inspection of the bank, cord blood collection sites, and cord blood processing and storage facilities. Because they perform a critical step of the cord blood banking process, facilities that collect cord blood units for an applicant bank are inspected during the accreditation process. Collection sites are selected depending on a number of variables to allow verification of compliance of all processes used by the bank.
- At least one staff member of the cord blood bank pursuing accreditation accompanies the inspector during the on-site inspection of collection sites. The FACT inspectorate consists of experienced individuals active in the field who have a strong and vested interest in ensuring the availability of the highest quality cord blood units for administration. The inspectorate includes transplant physicians, cord blood bank directors and medical directors, cord blood collection directors, and cord blood processing facility directors. Inspectors complete an inspector training course, pass a written exam, participate in at least one inspection as a trainee inspector, and participate in ongoing education.
- The cord blood bank will work with the selected collection sites during the preparation for inspection, including document submission, compilation of evidence, and scheduling the inspection. Any deviations noted during the inspection will be reviewed by the FACT Accreditation Committee comprised of leaders in the field of cord blood banking. The cord blood bank will be provided with the committee findings and is responsible for correcting any deficiencies identified. FACT encourages collection sites to maintain close communication with the cord blood bank as they prepare for an inspection.
By Mikaela VanMoorleghem, FACT Education and Training Coordinator
FACT’s success depends on the commitment of volunteer experts and their willingness to participate as peers to raise quality across providers, protect the research environment, and advance the field. We continuously rely on our inspectors to give back to the cellular therapy field by visiting their colleagues during on-site inspections, serving on FACT committees, and participating in educational events. Without this collaborative effort, FACT would not have the influence it has today.
In this issue of Just the FACTs, we recognize Paul Eldridge, PhD, Director, Cell GMP Facility UNC Bone Marrow Transplant and Cellular Therapy Program, in Chapel Hill, North Carolina, for his dedication to serving FACT.
Dr. Eldridge has been a FACT inspector for 18 years, and has performed 24 inspections. “For the past 18 years, I have enjoyed the satisfaction of participating in FACT activities. When a notice of inspector training was issued back in what now feels like the ‘early neo-lithic period,’ I volunteered with the hope of gaining some better insight about what would be required for my program to achieve accreditation. I was definitely able to meet my goal,” explains Dr. Eldridge. “I received far more than I expected by gaining access to a group of dedicated experts in hematopoietic cell transplantation with the mission of raising the quality of patient care and science in the field. The opportunity to discuss issues with sharp leaders and the prospect of visiting other facilities to observe how they have addressed needs and solved common problems has been invaluable to my professional growth and directly benefited my program.”
Dr. Eldridge currently serves as the Chair of FACT’s Standards Committee and is a member of the FACT Board of Directors. According to Dr. Eldridge, “One of the most appealing aspects of FACT as an organization is an openness to listening and soliciting ideas and viewpoints from everyone in our field. Embracing this, I have over the years become involved with various FACT working committees to address evolving needs of our community. This is a real chance to see firsthand how the mission of FACT is implemented from the kernel of an idea to the establishment of standards promoting best practices for cellular therapy. My experiences in serving on the Board of Directors, the Standards Committee, and as an inspector has been the source of much personal pride, especially when I see recognition of the success of FACT in improving the quality of our field from colleagues and patients.”
In the past year, Dr. Eldridge has led over 30 committee meetings; served as a FACT inspector; and presented on behalf of FACT at the first meeting of the African Blood and Marrow Transplantation Society (AFBMT) in Morocco, the American Society for Apheresis (ASFA) meeting in Chicago, and the International Society for Cell and Gene Therapy (ISCT) meeting in Montréal. Dr. Eldridge comments, “Talking with colleagues at FACT educational events and committee meetings is one of the most useful ways I have found to stay current on important topics. In my opinion, service to our patients and community is the underlying inspiration for the goals and mission of FACT. Nothing happens without help, though. When hands have been needed within FACT, I was glad to assist in acknowledgement for the benefits I have garnered.”
Andra Moehring, FACT Standards Development Specialist states, “Regardless of how many emails received or meetings attended, Dr. Eldridge always shows a positive attitude. He proves time after time that he is an exemplary leader through his plethora of knowledge and continued guidance on the FACT Standards Committee. He is responsive, considerate, kind, and fair. I have learned so much from working with him. FACT is lucky to have Dr. Eldridge as a volunteer.”
“As a global ambassador for FACT, Dr. Eldridge serves as the appointed representative to the Worldwide Network for Blood and Marrow Transplantation (WBMT),” states Linda Miller, FACT Chief Executive Officer. “Through his leadership, Dr. Eldridge ensures FACT’s mission of improving quality and safety for patients is shared with our cellular therapy colleagues throughout the world.”
Dr. Eldridge concludes, “Personally, and professionally, I have benefited immensely from FACT. I encourage everyone to consider becoming involved in the activities that keep FACT evolving and improving. The organization is only as strong as the people participating.”
The FACT Quality Management Boot Camps are popular meetings during which quality management principles are discussed in detail. A hallmark of the quality boot camp format is its focus on tangible examples directly used by accredited cellular therapy programs and cord blood banks. FACT invites cellular therapy and cord blood professionals to submit examples of innovative and effective quality management processes. The FACT Quality Management Committee will review and select commendable practices for presentation at a future quality boot camp. This is a great opportunity to showcase your organization’s success with your peers.
Do you have a quality management-related process that has worked particularly well for your organization? Are you a FACT inspector that has been impressed with an organization’s process? If so, please submit a description of the process and example documents to Heather Conway at firstname.lastname@example.org. Example processes include quality assessment activities, personnel training and competency, document control, procedural development, and other concepts related to quality management.
The next boot camp will take place during the WMDA-NetCord & FACT Cord Blood Day on September 14, 2018. Stay tuned for future boot camps in 2019!
The following individuals completed their first active inspection in the time period from May through July 2018. Congratulations and thank you for volunteering your time and expertise to advance cellular therapy! Organizations with personnel who also serve as FACT inspectors typically perform better during on-site inspections than their counterparts without an inspector. If you are interested in serving as an inspector, submit an online application! For a complete list of active FACT inspectors, view the online list of FACT Inspectors.
Markus Mapara, MD, PhD
Clinical Hematopoietic Cellular Therapy and Marrow Collection
New York Presbyterian Hospital/Columbia University Medical Center – Blood and Marrow Transplant Program
Folashade Otegbeye, MBChB, MPH
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy, and Marrow Collection
University Hospitals Seidman Cancer Stem Cell Transplant Program
Qing Zhu, MSN, RN
Stanford Medicine Blood & Marrow Transplant Program
Erwin Carino, PhD, MHA, RN
UCSF Medical Center Adult Blood and Marrow Transplant Program
Wanxing Cui, MD, PhD
Processing: Minimal manipulation of HPC and More than minimal manipulation of any cell type
Medstar Georgetown University Hospital Cell Therapy Manufacturing Facility
Premal Lulla, MD, MBBS
Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy, and Marrow Collection
Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
Leland Metheny, MD
Clinical Hematopoietic Cellular Therapy and Marrow Collection
University Hospitals Seidman Cancer Stem Cell Transplant Program
Kimberly Ward, BSN, RN, BMTCN
Levine Cancer Institute Transplant and Cellular Therapy Program
Memorandum of Understanding Signed by FACT and SBTMO to Develop Joint Accreditation Program in Brazil
The Foundation for the Accreditation of Cellular Therapy (FACT) and the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO), the Brazilian Society of Bone Marrow Transplantation, have announced its formal partnership to develop a joint FACT-SBTMO Cellular Therapy Accreditation Program in Brazil.
The agreement, in the form of a Memorandum of Understanding (MoU), formalizes the mutual interaction and strengthens the existing relationship between the SBTMO and FACT at the strategic and working level, focusing on standardization and accreditation of cellular therapy in Brazil.
Dr. Nelson Hamerschlak, SBTMO President states, “This partnership will bring a higher level of quality and outcomes for all Brazilian bone marrow transplant centers.” Dr. Hamerschlak leads the Hospital Israelita Albert Einstein (HIAE) in Brazil, the first Bone Marrow Transplantation Center in Latin America to receive FACT accreditation. HIAE is accredited for autologous and allogenic transplantation and cord blood banking.
For over 20 years, FACT has established international standards for hematopoietic cellular therapy product collection, processing, and administration. FACT administers its accreditation program in 25 countries. “The collaboration between FACT and SBTMO will support efforts to improve quality and patient safety at cellular therapy programs in Brazil in accordance with FACT-JACIE Standards,” said Linda Miller, FACT Chief Executive Officer.
“Through this partnership, FACT and SBTMO will work to increase access for patients to internationally accredited blood and marrow transplant programs in Brazil,” states Dr. Dennis Gastineau, FACT President.
QM Series 8: A Program’s Perspective: Controlling Different Types of Documents
August 29, 2018
The last webinar in the QM Series 8, Document Control, is on August 29, 2018, at 11:00 am ET. The entire document control process and system must be in place for all critical documents including labels, worksheets, and policies and procedures. Nicole Prokopishyn, PhD, Cellular Therapy Lab Director at Alberta Blood and Marrow Transplant Program, will explain the document control process of labels; Cynthia Morris, MSN, RN, CPHQ, Transplant Quality Program Manager at St. Jude Children’s Research Hospital, will discuss the document control process of worksheets; and Natalia Lapteva, PhD at the Houston Methodist Hospital Bone Marrow Transplant Program, will review the document control process of policies and procedures.
WMDA-NetCord & FACT Cord Blood Day
September 14, 2018
Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the inaugural WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 14, 2018, in conjunction with the Cord Blood Connect international congress.
The WMDA-NetCord & FACT Cord Blood Day will highlight issues that affect cord blood banks’ abilities to optimize processes within a challenging environment. The evolving demand for umbilical and cord blood products requires banks to consider changing indications and financial limitations on a continuous basis. Accreditation encourages implementation of efficient, quality-driven processes to meet these demands while banking products suitable for clinical administration.
Morning presentation topics include global perspectives of cord blood transplants, ethical dilemmas in cord blood banking, common FACT-NetCord accreditation citations, and an overview of the WMDA cord blood bank survey. The afternoon has two breakout sessions including a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track. We encourage banks to send multiple personnel to attend the various tracks as well as enlist a member to become a FACT inspector.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. Register by August 31 and save $135! Registration fees are waived for FACT active and trainee inspectors.
The Impact of CAR-T Cell Therapy and FACT Standards on the Role of the Pharmacist
September 19, 2018
Nicole Watts, PharmD, BCOP, Clinical Pharmacy Specialist at the University of Alabama at Birmingham, will discuss the role of pharmacists in the management of immune effector cellular therapy and provide updates to the FACT pharmacy requirements. Dr. Watts will also provide education regarding toxicity identification and management, including CRS and CRES, the role of Tocilizumab, and the role of steroids.
World Cord Blood Day
November 15, 2018
Join the Save the Cord Foundation for the second annual World Cord Blood Day on November 15, 2018. The day will feature a free virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood. As an Inspiring Partner, FACT will share stories from cord blood banks and transplant programs about the importance of establishing quality systems in collection, banking, and transplant. Expectant parents, healthcare professionals, and the public are invited to attend.
Defining, Assessing, and Documenting Cord Blood Warming Events
November 29, 2018
Anytime that the temperature is above -150° C should be considered a potential warming event. Because unit volumes are small and are frozen in bags with large surface areas, their thermal kinetics are greatly affected by their environment. Join Phillip Johnson MMedSc(Path), BAppSc(MedSc), Production Manager at Queensland Cord Blood Bank at the Mater, for a presentation regarding methods used to define, assess, and document cord blood warming events.
Completing an Annual/Renewal Report in the Portal
Applicant Training Session
Join FACT’s IT Business Analyst for training on completing an annual or renewal report in the new FACT Accreditation Portal. Alisa Forsythe will discuss the navigation and features within the portal as well as the process for completing the application, the director approval process, and application submission. Webinar participants will have a chance to ask questions at the end of the presentation.
Completing a Compliance Application in the Portal
Applicant Training Session
Join FACT’s IT Business Analyst for training on completing a compliance application in the new FACT Accreditation Portal. Alisa Forsythe will discuss the navigation and features within the portal as well as the process for completing the application, the director approval process, and application submission. Webinar participants will have a chance to ask questions at the end of the presentation.
Performing an Inspection in the Portal
Inspector Training Session
Join FACT’s IT Business Analyst for training on performing an inspection in the new FACT Accreditation Portal. Alisa Forsythe will discuss the inspector specific navigation and features within the portal as well as the process for reviewing the applicant data, entering inspection findings, reviewing the inspection report, and submission. Webinar participants will have a chance to ask questions at the end of the presentation.
FACT’s season of annual meetings is winding down, and as everyone gets back to their homes and day jobs, I hope you have time to rest and reflect on the relationships built and progress made during the past several months. FACT continues to have a presence at the annual meetings of its parent societies, ASBMT and ISCT, and those of other partner organizations, including ASFA, ASGCT, ASH, and SITC. We look forward to participating in the inaugural Cord Blood Connect congress in September, hosted by the Cord Blood Association.
The articles in this newsletter reflect many of the lessons learned and accomplishments made possible by meeting with our colleagues in person at these meetings. Some discussions were complex and nuanced, such as the BMT Time Out commendable practice identified by the FACT Clinical Outcomes Committee and advice on adverse event reporting. Some discussions were intently focused on large tasks, such as review of the draft second edition of the FACT Common Standards in preparation for the public comment period. Other events welcomed new inspectors to the FACT community and celebrated the accomplishments of outgoing Board members.
We appreciate everyone’s participation in the in-person events, and also via volunteer committee teleconferences. Please allow the energy and excitement of these meetings to influence the important work you do on a daily basis.
Dennis A. Gastineau, MD
Publication of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy, Seventh Edition
By Andra Moehring, FACT Standards Development Specialist
Congratulations to Dr. Paul Eldridge, FACT Standards Chair, and the FACT-JACIE Standards Committee on publishing the seventh edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration on March 1, 2018. The Standards will become effective on May 30, 2018.
The Foundation for the Accreditation of Cellular Therapy (FACT) has several committees to help FACT achieve its vision of being the premier organization setting standards and awarding accreditation to programs in the evolving field of cellular therapy.
The seventh edition FACT-JACIE Standards Committee is comprised of 58 representatives from around the world who worked for 23 months on the development of the Standards. The committee is divided into four subcommittees: Clinical, Collection, Processing, and Quality Management. The FACT Immune Effector Cell (IEC) Task Force was also involved in the development and review of IEC specific requirements. Everyone’s commitment, expertise, and experience is invaluable to these Standards.
The seventh edition of the Standards contains important additions and changes to requirements to reflect current processes typical in a cellular therapy program. These changes maintain the relevance of the Standards in the field of cellular therapy.
Public Comment Period
During the 90-day public comment period, 653 comments were submitted by 78 contributors residing in 12 different countries. The committee was responsive to public comments and requests made on behalf of related organizations to ensure the seventh edition is broadly accepted throughout the cellular therapy community.
FACT and JACIE greatly appreciate contributors taking the time to review the draft Standards and submit comments.
Accessing the Standards and Other Resources
The Standards, accompanying Accreditation Manual, summary of changes, and crosswalks are available on the FACT website at http://www.factwebsite.org or by using the links provided below:
Dr. Eldridge presented a webinar on how to “Effectively Transition to the 7th Edition Hematopoietic Cellular Therapy Standards” on March 14, 2018. Based on the questions received, a question and answer document was created to assist those who were unable to attend. If you were unable to attend the webinar, you can purchase the recording. FACT inspectors may download the recording for free!
If you have questions related to the seventh edition FACT-JACIE Standards, contact your FACT Coordinator or submit your question to email@example.com.
Thank you for all of your contributions!