By Mikaela VanMoorleghem, Education and Training CoordinatorFoundation for the Accreditation of Cellular Therapy
Draft Seventh Edition NetCord-FACT International Cord Blood Standards Available for Public Comment
The Foundation for the Accreditation of Cellular Therapy (FACT) published the draft Seventh Edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration and accompanying Accreditation Manual for inspection and public comment for a 90-day period. Comments will be accepted from November 30, 2018 through March 1, 2019.
The Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.
Description and Instructions for Review and Comment
Draft NetCord-FACT Cord Blood Standards
Draft NetCord-FACT Accreditation Manual
Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form. Comments will be accepted through March 1, 2019.
Serve as a Volunteer FACT Inspector and Enjoy the Benefits!
FACT invites you to take a step forward and serve as a volunteer FACT inspector. As a nonprofit organization that aims to provide accreditation services for the highest possible value, we rely on volunteer inspectors and the leadership of their accredited organizations to be supportive of their time and dedication to FACT activities.
Possibly the greatest benefit inspectors experience is the opportunity to give back to the field of cellular therapy and cord blood banking. There are also many other benefits enjoyed by inspectors, and their organizations, including:
- Learning new practices and techniques from other organizations;
- Networking with peers for ideas, questions, and collaboration;
- Sharing knowledge and expertise with others;
- Discovering a variety of ways to meet FACT Standards;
- Reflecting on their own organizations’ practices;
- Developing professional skills and accomplishments;
- Accessing FACT educational sessions free of charge; and
- Taking advantage of opportunities to serve on FACT committees.
Organizations with inspectors experience increased exposure to the cellular therapy and cord blood community and have more opportunities to provide feedback on the development of standards and accreditation requirements. There is also evidence that organizations without inspectors have more difficulty complying with current standards. While inspections do require some time away from work, this time is an investment in an organization’s knowledge of FACT requirements and various methods of compliance.
FACT encourages you to review the inspector requirements, and submit your application today!
FACT Global Initiatives Continue to Expand
FACT continues to develop its international collaborations through regional initiatives aimed at providing educational assistance and accreditation activities tailored to the needs of the global communities.
FACT-JACIE Stepwise Accreditation in Latin America
In an effort to provide an incremental approach to accreditation, FACT and JACIE have partnered to offer a stepwise accreditation program in Latin America. This stepwise approach to accreditation would enable programs to focus on their quality systems first and ensure operations for patient and donor safety. The second phase would build on the established foundation to develop a complete quality management program and provide for efficacious care. The final step evaluates the effectiveness of the quality program, ensures reporting to the appropriate regulatory and accrediting agencies, and evaluates clinical outcomes. The first FACT-JACIE Stepwise Inspection took place in Argentina on November 20-21, 2018.
A broad group of ten participating bone marrow transplant centers throughout India is participating in the new India Working Group designed to address the regional needs of the country. The centers are completing self-assessments of their programs to identify any potential barriers to compliance with FACT Standards, clarify the intent of requirements, and assess their readiness for accreditation.
A FACT Standards and Accreditation Workshop was held on November 2, 2018 during the annual meeting of the Asia-Pacific Blood and Marrow Transplantation Group (APBMT) in Taipei, Taiwan. Presentations included the importance of integrating a quality management system throughout the clinical, collection and cell processing activities; the accreditation experience of the National University Health System in Singapore; the incentives for seeking international accreditation from the Tata Medical Center in Kolkata; and the need for standardization and accreditation in China.
Following the execution of a formal Memorandum of Understanding (MoU) in August, FACT and the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) created a FACT-SBTMO Task Force. The first meeting of the Task Force was conducted on October 17, 2018 to review the strategic goals and operational aspects of the joint FACT-SBTMO Accreditation Program. A survey of the Brazil transplant centers will be distributed in November to gather data related to the volume and type of transplants performed, program structure, personnel, facilities, and quality management systems. The information will be used to identify areas of educational need and ascertain readiness for accreditation.
FACT Announces Accreditations Awarded in Third Quarter of 2018
During the third quarter of 2018, 20 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.
FACT Education Events:
FACT Webinar: The Parts and Pieces of Validations and Qualifications – January 9, 2019
Join FACT for a webinar on validations and qualifications on Wednesday, January 9, 2019, at 11:00 am ET, 16:00 GMT. Dr. Tom Leemhuis, Laboratory Director at Hoxworth Blood Center University of Cincinnati Academic Health Center, will discuss the essentials of validations and qualifications and the FACT-JACIE Seventh Edition Standards requirements.
View meeting details and register
FACT Cellular Therapy Inspection and Accreditation Workshop at TCT Meetings - February 19, 2019
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. Clinical programs are currently adapting to immune effector cellular therapy accreditation requirements and changes in the FACT-JACIE Seventh Edition Hematopoietic Cellular Therapy Standards. This workshop will address important topics in the cellular therapy field including:
- Overview of FACT Accreditation Processes
- Common Citations Overview
- Integration of Immune Effector Cells into Accreditation
- Using the Tracer Methodology to Assess Compliance with FACT Standards
- Risk Evaluation and Mitigation Strategies (REMS)
- How to prepare for and conduct inspections
- Data Management
- Clinical Outcomes
The workshop includes two tracks: New Inspector Training and General Sessions for active inspectors, applicants, and accredited programs. The Inspector Training track includes sessions on pre-inspection review, the ins and outs of performing an on-site inspection, how to conduct an exit interview, and how to prepare an inspection report. The General Sessions will review commonly cited deficiencies in the areas of quality management; personnel; and donor selection, evaluation, and management. This track also includes sessions on how to use the Tracer Methodology to assess compliance with FACT Standards, and risk evaluation and mitigation strategies. Sessions are accompanied by exercises and group discussions to apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Track.
View meeting details and register online
Cellular Therapy Leadership Course at TCT Meetings – 101, February 19, 2018
Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.
View meeting details and register
Cellular Therapy Advanced Leadership Course at TCT Meetings – 201, February 19, 2019
If you completed FACT’s Cell Therapy Leadership 101 course in a previous year and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.
View meeting details and register online
Register for the ASBMT-FACT Quality Boot Camp at the TCT Meetings - February 20, 2019
Join us for the FACT-ASBMT Quality Boot Camp at the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR on February 20 in Houston, TX.
This year’s boot camp will focus on core quality concepts and quality processes programs have implemented. Members of the FACT Quality Committee and the ASBMT Administrative Directors SIG Quality Working Group will distribute self-assessments in the months leading up to the TCT Meeting to review key features of your quality program and identify ongoing challenges. Strengthen your quality assurance processes by completing the self-assessments, attending the in-person workshop, and joining the roundtable discussions.
View meeting details and register
Quality Management Series, Module 9: Auditing
The Quality Management Series Module 9 includes four sessions about auditing. The first session, Auditing: Planning and Executing, will be on January 23, 2019, at 11:00 ET. Leigh Poston, BMT Program Quality Management Coordinator at UF Health Shands Hospital, will discuss designing audit strategies, identifying specific audits to perform, creating an audit schedule, determining the scope of the audit, and executing the audit.
The second session, Auditing: Summarizing and Evaluating the Data, will be on March 6, 2019, at 11:00 am ET. Ed Brindle MSc, MLT, BMT Quality Manager at UHN Blood and Marrow Transplant Program, will discuss writing the audit report, determining WHY the errors occurred, and assigning appropriate corrective action and preventive action.
Register for the entire module to receive a 15% discount!
Register for the entire QM Series Module 9: Auditing
Register for Auditing: Planning and Executing
Register for Auditing: Summarizing and Evaluating the Data
Upcoming sessions in the series include:
- Auditing: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors (TBA)
- A Program's Perspective: Auditing (TBA)