President’s Letter
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.
Sincerely,
Dennis Gastineau
In Memory of Michael Lill, M.D.
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.
Dennis
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
Study Compares Standards and Accreditations
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
Founding FACT Board Member Nancy H. Collins, PhD Receives ISCT Career Achievement Award
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!
FDA Releases Six Draft Guidance Documents for Gene Therapy
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.
Read FDA Commissioner’s Statements
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
Long Term Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry
Disease-Specific Draft Guidance Documents
Human Gene Therapy for Hemophilia; Draft Guidance for Industry
Human Gene Therapy for Rare Diseases; Draft Guidance for Industry
Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry
FACT Submits Comments to Governmental Agencies
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 kwacker@unmc.edu by August 31, 2018.
Data Management Resources Serve as Gateway to Improving Reporting
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:
FACT and CIBMTR Announce Joint Data Audit Program
The Role of Medical Records During On-Site Clinical Program Inspections
FACT Accreditation a Criterion for 2018-2019 Best Hospitals List and Best Children’s Hospitals List
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!
See list of Best Hospitals
Review ranking methodology for Best Hospitals
See list of Best Children’s Hospitals
Review ranking methodology
Cord Blood Accreditation Committee Activity Update
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.
Selection of Cord Blood Collection Sites for FACT Inspections
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.
