FACT Events at the 2020 TCT Meetings Were a Success!

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

FACT hosted several popular events at the 2020 TCT | Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR in Orlando, Florida. On February 18, the FACT Cellular Therapy Inspection and Accreditation Workshop brought together 155 attendees. The workshop included two tracks: Applicant training and inspector training. The applicant track described the accreditation process from application to accreditation.  Applicants were given a short overview on how to navigate the accreditation application in the Accreditation Portal, and evaluated documentation to ensure compliance.  In addition, applicants learned how to organize the on-site inspection process, structure a program tour, evaluate deficiencies, and maintain accreditation readiness.

The inspector training track was required for all inspector trainees. This track was designed to guide the trainee through the inspection experience: from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee received an inspection checklist accompanied by applicable inspection documents. Trainees were instructed on the duties of the inspector prior to the inspection and how to navigate an application using the Accreditation Portal.  Also, trainees developed a plan for review of documents submitted in advance of the on-site inspection, evaluated documents to determine compliance, used an inspection checklist, and prepared for all duties post-inspection.

Also on February 18, FACT hosted two Cellular Therapy Leadership Courses for over 30 people who have, or aspire to, a leadership position in cell therapy. Attendees of the Cellular Leadership 101 course learned a variety of leadership strategies including:
• The leader as coach
• Differences between managing and leading
• Basic styles of leadership and how to recognize your own style
• When each style of leadership may be appropriate
• Chairing and participating in effective meetings
• Delegation skills
• How to build consensus
• Ways to motivate, ignite, inspire, transform and engage teams

Participants who participated in the Advanced Cellular Therapy Leadership Course dug deeper into leadership skills and organizational health, and examined the following topics:

  • Characteristics of a healthy organization
  • Adapting an organization to a changing environment
  • Leading from where you are
  • Multiplying and diminishing team effectiveness
  • Servant leadership
  • How to be change agent
  • Effective governance boards
  • Legal liability and fiduciary responsibilities in decision-making
  • Strategic planning with a focus on outcomes

On February 19, FACT teamed up with ASTCT to host the 5th annual Quality Boot Camp, setting record breaking attendance with over 160 participants.   The day featured many interactive sessions, including how to assess the effectiveness of your Quality Management Program, practicing interview techniques when performing an audit, and identifying the difference between a verification, qualification, audit, and validation.  Attendees were engaged throughout the day, asking questions and participating in productive discussions.  One attendee commented, “the speakers made the presentations relative to actual practice – not just definitions on slides.  Overall, the boot camp made my trip to Orlando worthwhile and offered more learning opportunities…”

On February 20, FACT hosted a Mingle and Mimosas Networking Event for Inspectors to show our appreciation and toast our essential volunteers for their continued dedication and time devoted to FACT.

Special invitations were extended to all international delegates attending the TCT Meetings for a wine and cheese reception on February 20. Members of the FACT Global Affairs Committee presented information about the international accreditation program featuring a stepwise certification approach in Latin America, the new joint FACT-SBTMO Accreditation Program in Brazil, and efforts to provide guidance to transplant centers in India. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

In addition to these events, FACT welcomed visitors to its exhibit booth and invited meeting participants to the booth to meet the leaders of Accreditation Services and have accreditation and standards questions answered.

All events were successful and FACT looks forward to the 2021 Transplantation and Cellular Therapy Meetings in Hawaii!


FACT Announces Events at the 2020 TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

Posted in :: 2019 Volume 9 :: Thursday, September 26th, 2019

We invite you to join us for upcoming FACT events at the 2020 TCT Meetings!

FACT Cellular Therapy Inspection and Accreditation Workshop – February 18

FACT will conduct a Cellular Therapy Inspection & Accreditation workshop on February 18, 2019, at the World Center Marriott in Orlando, Florida. This workshop will provide an immersive experience for personnel preparing for the accreditation process and a full day training session for FACT inspector trainees.

Register for the FACT workshop
Apply to be a FACT inspector

Cellular Therapy Leadership Course 101 at TCT Meetings – February 18

Do you want to improve your leadership skills? Everyone wins when leaders get better. This half-day course is designed to help you hone your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.

Register for the Leadership Course 101

Cellular Therapy Advanced Leadership Course 201 at TCT Meetings – February 18

If you completed FACT’s Cellular Therapy Leadership 101 course and want more, the 201 course is for you.

This advanced workshop drills deeper into organizational development and leadership skills. Participants in the prerequisite Cellular Therapy Leadership 101 course in the morning, or if attended in a previous year, are eligible to register for the 201 course in the afternoon.

Register for the Advanced Leadership Course 201

FACT-ASTCT Cellular Therapy Quality Boot Camp – February 19

Focused on issues identified by FACT compliant transplant programs, sessions will include activities and discussion designed to strengthen your quality assurance processes. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution.

Register for the FACT-ASTCT Quality Boot Camp

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session February 20

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

Register for the FACT Global Affairs session


FACT-SBTMO Joint Accreditation Program Launched in Brazil

Posted in :: 2019 Volume 8 :: Thursday, August 29th, 2019

SBTMO President, Dr. Nelson Hamerschlak, pictured with Dr. Phyllis Warkentin and Dr. Carlos Bachier.

Approximately 70 representatives of bone marrow transplant centers attended the FACT-SBTMO Accreditation Program Workshop on July 31, 2019; an initiative that is the result of the partnership between the Brazilian Society of Bone Marrow Transplant (SBTMO) and the Foundation for the Accreditation of Cellular Therapy.

The meeting clarified the requirements and the operational dynamics of the accreditation process for Brazilian cell therapy transplant centers.

As Carlos Bachier and Phyllis Warkentin of the FACT Global Accreditation Committee have reported, it may seem complex at first, but it is certainly possible to complete each of the gradual steps in the process toward accreditation.

Check out the chat between Dr. Nelson Hamerschlak, Dr. Carlos Bachier, and Dr. Phyllis Warkentin on SBTMO’s official YouTube.

The accreditation will be valid for 3 years. The estimated time to complete the initial certification cycle is 2 years. The program was designed taking into account the structure and operations of the Brazilian centers, including the interest of the 39 TMO centers that responded to the SBTMO Online Survey distributed to gather the demographics of the national transplant programs.

For over 20 years, FACT has established international standards for the collection, processing and administration of hematopoietic cell therapy products. It is worth mentioning that Brazil was the pioneer in Latin America when in 2012 Hospital Israelita Albert Einstein (HIAE) was awarded FACT accreditation. Albert Einstein has been re-accredited in 2015 and 2018.

In addition to Brazil, FACT has accredited 255 cell therapy programs in 6 countries: Canada, Mexico, New Zealand, Australia, Singapore, United States.

It is noteworthy that FACT accreditation is based on the FACT-JACIE (The Joint Accreditation Committee ISCT-Europe & EBMT) Standards, which is Europe’s only official accreditation body in the field of HSCT and cell therapy.

Expression of Interest

If you wish to express your interest in joining the accreditation program in Brazil, please send the following data to SBTMO – via contato@sbtmo.org.br or FACT – via fact@unmc.edu

Data

  • Transplant Center Name
  • Name of Contact Person
  • Full address

Put in the subject line of the message : “FACT-SBTMO Accreditation”

 


Upcoming Educational Events

Posted in :: 2019 Volume 2 :: Tuesday, February 12th, 2019

FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR

Cellular Therapy Inspection & Accreditation Workshop
February 19, 2019
Houston, Texas

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.

Register for the FACT workshop

Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Houston, TX 

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 20, 2019
Houston, TX 

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
View workshop agenda

FACT-ASBMT Quality Boot Camp
February 20, 2019
Houston, Texas

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 a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges.  Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.

View meeting details and register
View Quality Boot Camp agenda

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
Houston, TX

The Foundation for the Accreditation of Cellular Therapy (FACT) invites international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.

View meeting details and register

FACT Inspectors are Invited to Social Hour during TCT Meetings

In honor of their dedication and service provided to the cell therapy community, FACT Inspectors are cordially invited to attend the FACT Inspector Social Hour on Friday, February 22, 2019 at the Hilton Americas-Houston Hotel, Room 335B from 5 pm – 6 pm. Light hors d’oeuvres and cocktails will be provided.

Visit FACT at Exhibit Booth 2254!

During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.

Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.

2019 TCT Exhibit Booth Hours:

Wednesday, February 20

7:00 a.m. – 2:00 p.m.

Thursday, February 21

7:00 a.m. – 2:00 p.m.

Friday, February 22

7:00 a.m. – 1:00 p.m.

Saturday, February 23

7:00 a.m. – 1:30 p.m.

QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
Webinar

This webinar 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. This is the second webinar in the QM Series 9: Audits.

Register online

FACT Cellular Therapy Collection Workshop at 2019 Annual ASFA Meeting
May 15, 2019
Portland, Oregon

Join FACT on Wednesday, May 15, at the Hilton Portland Downtown in Portland, OR, for a workshop designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities.

FACT representatives will be in attendance to discuss cellular therapy collection challenges, provide examples on how to maintain quality when faced with different collection protocols, and present a common citations overview. This workshop also includes inspector trainee sessions on how to perform a FACT inspection from start to finish.

View meeting details and register

FACT Cellular Therapy & Cord Blood Inspection at Accreditation Workshop at the 2019 Annual ISCT Meeting
May 28, 2019
Melbourne, Australia

This workshop will provide well-rounded information on the process of accreditation, requirements in the FACT Standards, and how immune effector cellular therapy fits within the realms of cellular therapy and cord blood banking. This event is a must-see opportunity for the following audiences.

  • Blood and marrow transplant (BMT) programs
  • Cord blood banks
  • Cell processing laboratories
  • Physicians, scientists, and principal investigators
  • Unit supervisors, laboratory managers, administrators, nurses, and medical technologists
  • Quality managers

Separate tracks will be available for cellular therapy programs and cord blood banks, followed by training specific to inspector trainees.

View meeting details and register

ISCT-FACT Quality Boot Camp at 2019 ISCT Annual Meeting Pre-Conference Day
May 29, 2019
Melbourne, Australia

Is your cell processing facility FACT accredited or looking to comply to FACT standards? Strengthen your quality assurance program through this interactive workshop with FACT experts and real world applications.

Focused on issues identified by FACT-compliant transplant programs, these sessions will include activities and discussion in four main topic areas. Come prepared with your quality program questions and leverage quality experts to identify process improvement opportunities you can apply at your organization.

View information and register for ISCT pre-conference day

FACT Cellular Therapy Inspection and Accreditation Workshop at CBMTG Annual Meeting
June 5, 2019
Calgary, Alberta, Canada

The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. This workshop will address important topics in the cellular therapy field including:

o Overview of FACT Accreditation Processes
o Common Citations Overview
o Integration of Immune Effector Cells into Accreditation
o Using the Tracer Methodology to Assess Compliance with FACT Standards
o Risk Evaluation and Mitigation Strategies (REMS)
o How to Prepare for and Conduct Inspections
o Data Management
o 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. 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

WMDA-NetCord & FACT Cord Blood Day at 2019 Cord Blood Connect International Congress
September 12, 2019
Miami, FL

Join your cord blood colleagues for a day of presentations from renowned cord blood experts at the 2019 WMDA-NetCord & FACT Cord Blood Day! The event will be held in Miami, Florida on September 12, 2019, in conjunction with the Cord Blood Connect International Congress.

The WMDA-NetCord & FACT Cord Blood Day will highlight recent advances in cord blood transplantation and include global perspectives of cord blood transplants, common FACT-NetCord inspection citations, and more. The afternoon consists of two breakout sessions: 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. Registration fees are waived for FACT active and trainee inspectors. Apply to be a FACT inspector!

View meeting details and register online


FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019

FACT International Accreditation

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements. Register to attend!


Upcoming Educational Events

Posted in :: 2019 Volume 1 :: Wednesday, January 16th, 2019

Exceptional Release of Commercial Cellular Therapy Products
January 30, 2019
Webinar

Join FACT on January 30, 2019, at 11:00 am ET, 1600 GMT, for a webinar titled, Exceptional Release of Commercial Cellular Therapy Products. Autologous cellular therapy products can be irreplaceable, and exceptional release of nonconforming products may be necessary to the well-being of patients. FACT-accredited programs are increasingly using autologous products that are licensed by regulatory authorities, and sometimes these products do not meet specifications. In this webinar, presenters will discuss FACT requirements for exceptional release, and then share their centers’ processes for release of nonconforming commercial cellular therapy products in the United States.

Webinar presenters include:

Dr. Phyllis I. Warkentin, Chief Medical Officer of FACT
Dr. Premal Lulla, Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
Dr. Elizabeth Shpall, MD Anderson Cord Blood Bank Medical Director, MD Anderson Cellular Therapy Transplant Program Director, and co-director of the MD Anderson CARTOX program.
Dr. Phillip McCarthy, of Roswell Park Comprehensive Cancer Center – Transplant and Cellular Therapy Program for Adult Inpatient, Outpatient, and Pediatric Outpatient Programs – John R. Oishei Children’s Hospital

Register online

Validation Principles and Protocols for Cellular Therapies
February 6, 2019
Webinar

Join FACT for a webinar, Validation Principles and Protocols for Cellular Therapies, on Wednesday, February 6, 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 Validation Principles and Protocols for Cellular Therapies, and the FACT-JACIE Seventh Edition Standards requirements.

Register online

FACT Events at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR

Cellular Therapy Inspection & Accreditation Workshop
February 19, 2019
Houston, Texas

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.

Register for the FACT workshop

Cellular Therapy Leadership Course at TCT Meetings – 101
February 20, 2019
Houston, TX 

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 20, 2019
Houston, TX 

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

FACT-ASBMT Quality Boot Camp
February 20, 2019
Houston, Texas

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 a self-assessment prior to the TCT Meetings to review key features of your quality program and identify ongoing challenges.  Strengthen your quality assurance processes by completing the self-assessment, attending the in-person workshop, and joining the roundtable discussions.

View meeting details and register
View preliminary agenda

FACT Global Affairs: International Delegates of the TCT Meetings Invited to Attend Special Session
February 21, 2019
Houston, TX

The Foundation for the Accreditation of Cellular Therapy (FACT) would like to invite international delegates to a special session during the 2019 TCT | Transplantation & Cellular Therapy Meetings of ASBMT & CIBMTR to be held in Houston, Texas at the Hilton Americas, room 335C on Thursday, February 21, 2019 from 5:00 pm to 7:00 pm.

Join us for a wine and cheese reception where members of the FACT Global Affairs Committee will provide information about the international accreditation program featuring a stepwise certification approach. The new program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.

View meeting details and register

Visit FACT at Exhibit Booth 2254!

During the 2019 TCT Meetings, FACT invites you to visit us at exhibit booth #2254! FACT staff will be available to answer your questions about standards, accreditation services, inspections, and FACT consulting.

Whether you are a new inspector or a long-time friend, please stop by and say hello. We would enjoy the opportunity to thank our committee members and inspectors in person for their hard work and dedication.

2019 TCT Exhibit Booth Hours:

Wednesday, February 20

7:00 a.m. – 2:00 p.m.

Thursday, February 21

7:00 a.m. – 2:00 p.m.

Friday, February 22

7:00 a.m. – 1:00 p.m.

Saturday, February 23

7:00 a.m. – 1:30 p.m.

QM Series 9: Auditing: Summarizing and Evaluating the Data
March 6, 2019
Webinar

This webinar 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. This is the second webinar in the QM Series 9: Audits.

Register online


Global Affairs

Posted in :: 2018 Volume 4 :: Friday, November 9th, 2018

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 is scheduled to be conducted in Argentina on November 20-21, 2018.

India

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.

Asia-Pacific

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.

Brazil

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.