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accreditation statistics

As of April 1, 2021

Cellular Therapy Entities

  • Accredited: 237
  • Applicants: 21

Cord Blood Banks

  • Accredited: 58
  • Applicants: 8

A complete list of accredited organizations can be found at www.factwebsite.org.

Congratulations to the following organization for achieving its initial FACT accreditation:

GW Cancer Center Stem Cell Transplantation and Cellular Therapy Program, Washington, DC

Director: John Barrett, MD

Adult Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections (Part 2)

Posted in :: 2021 Volume 3 :: Thursday, April 22nd, 2021

By Stacy Freeburg, FACT Accreditation Coordinator

FACT-accredited organizations voluntarily seek and maintain FACT accreditation via a rigorous process, demonstrating their commitment to quality and their belief that patient needs are paramount. Obtaining and maintaining FACT Accreditation is a major undertaking.

Recognizing that we are a peer-driven organization, we invited a few organizations who are currently FACT accredited to share their suggestions for how to maintain many of the documents required for FACT Accreditation.

How does your program organize various documents so that they are readily available, such as current licenses, specialty certificates, or CVs?

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

This is a challenge. For large education sessions that are renewable (e.g., Risk Management Program (RMP) training), we have started using the Training Courses module in our Q-Pulse quality management software. This allows for central management and electronic record keeping.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

This information is reviewed on an annual basis to ensure documents are up to date and organized for each employee in our employees’ FACT folders. If updates are needed, the information is requested directly from the employee or obtained though administrative staff. The timing of the annual review of the employees’ FACT folders corresponds with our hospital’s annual employee evaluations. Copies of licensure and certificates for key personnel are stored in a shared electronic folder to allow access to those who may require it throughout the year.

How does your program compile and maintain the educational activities list?

Richard Makin, Immune Effector Cell Quality Manager, NSW Health Agency for Clinical Innovation with The Children’s Hospital at Westmead Blood and Marrow Transplant Service

For the last six to seven years, we have been providing a “BMT Masterclass”. The schedule of topics is based on the FACT requirements. This is a virtual presentation or prerecording. These are recorded and subtitled and placed on our website at https://aci.health.nsw.gov.au/networks/blood-and-marrow-transplant/resources. All members of BMT Nurses, Scientist, Physicians, and Pharmacists in New South Wales (NSW) and across Australia have access. We also run a “Introduction to BMT” session once a year, a scientific forum, and senior nurses’ day.  We use a basic template for recording.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute and Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

Our program utilizes the FACT Educational Activities Form throughout the program departments to document cellular therapy education on an annual basis. Key team members maintain their own educational activities form, and the form is part of the annual audit of the individual employees’ FACT folder.

Stacy Freeburg, FACT Accreditation Coordinator, FACT Accreditation

When I worked in direct health care, a sign-in sheet was provided for all internal training to document educational activities. Information gathered included training title, date and length of the training, title of the training, and attendees’ name. In addition, staff were expected to submit documentation of any external training to a central location. This information was compiled onto a word document for each staff member (similar to the FACT Educational Activities Form). The sign in sheets also provided documentation that the organization provided opportunities for staff for educational activities.

 Staff also were required to update their educational activities in a system tied to the Human Resources department’s intranet. Information gathered included the activities’ titles and dates and length of training. Activities could be webinars, reading an article, etc. Staff were then able to print out a summary form. All staff were required to turn in a copy during their annual personnel evaluation, which demonstrated compliance with requirements and made it readily available for submission for accreditations.

Benefits of Documenting Educational Activities

Documentation is not only a way to document educational activities for FACT Accreditation, but can also be a resource for planning future training needs. To maximize the usefulness of educational activity records, it is important that they be up to date, organized for easy retrieval, and have a mechanism to for review. By reviewing the types of educational activities staff have attended, programs can determine what education is needed. For example, the program may wish to expand opportunities to include tumor board discussions, review of peer reviewed articles, or ensuring that staff have the opportunity to attend various professional conferences.

As noted above, gathering licenses and educational activities is challenging. Tying the submission to annual performance evaluations or having an annual audit to verify it is complete are two methods to avoid a panic when you need to submit the information.

Download the FACT Educational Activities Form


Learning from Each Other: Accredited Organizations’ Advice for Preparing for FACT Inspections

Posted in :: 2021 Volume 2 :: Tuesday, March 2nd, 2021

By Stacy Freeburg, FACT Accreditation Coordinator

FACT accreditation is the threshold for excellence in cellular therapy, including blood and marrow transplantation, immune effector cellular therapy, and cord blood banking. FACT-accredited organizations voluntarily seek and maintain FACT accreditation via a rigorous process, demonstrating their commitment to quality and their belief that patient needs are paramount. Obtaining and maintaining FACT Accreditation is a major undertaking.

Recognizing that we are a peer-driven organization and beginning to resume inspections, we invited a few organizations who are currently FACT accredited to share their suggestions for obtaining and maintaining FACT accreditation. In this article, we focus on improvements programs made to their accreditation preparation based on their experience.

What changes did you make after accreditation was awarded to make the next cycle a bit easier?

Richard Makin, Immune Effector Cell Quality Manager, The Children’s Hospital at Westmead Blood and Marrow Transplant Service

–  A big one is START EARLY. When completing the Compliance Application, we try to get our documents as up to date as possible in the months beforehand so we do not make any changes when submitting documents. It is too hard to do in parallel and too time consuming. It is not really meeting the expectation of compliance either: documents and procedures need to be in active use when the inspectors come to assess.

– Conduct regular FACT meetings. We have monthly FACT meetings throughout the accreditation cycle on top of the quarterly large meeting where we summarize the majority of the quality system elements.

– We have found reviewing Immune Effector Cell data every 2nd Quarterly Quality Meeting useful. This has enabled us to get enough data on efficacy and outcome. It also gives us more time to drill down to the significance of results.

– The paediatric ANZCHOG (now TACTIC) annual meeting (Australia + New Zealand) has been a key meeting for reviewing patient outcomes. This is really well supported by our registry (Australasian Bone Marrow Transplant Recipient Registry), who provides sites specific reports. Each centre provides an overview of all their patients and treatments used. The meeting has expanded to include nurses, quality managers, data managers, pharmacists, and scientists in addition to the treating physicians. This is excellent for real-world data analysis, collaboration, and continuing education.

– The annual report of quality activities has been a very useful tool for quality improvement and has grown to many pages. Again, we need to start early as it takes a long time to compile.

– Our registry has been very helpful in working with us on benchmarking outcomes. When this became a requirement a few years back, we sat down and came up with a plan. Now they have standard database report with indications, transplant numbers, engraftment, GVHD, and survival graphs comparing other sites in Australia and New Zealand. This has helped a lot rather than analyzing ourselves.

Elisha Nixon, Quality Program Manager, Walter Reed National Military Medical Center, Murtha Cancer Center Research Program, Uniformed Services University of the Health Sciences, The Henry M. Jackson Foundation

After our program identified significant deficiencies during our FACT inspection in October 2016, a new Quality Manager was brought on board to revamp the entire program. Processes within the administrative, clinical, and laboratory processes were all modified to a significant extent. Following re-inspection, our program was granted re-accreditation in March 2018. Failure was not an option, and a change in mindset helped staff recognize that every Request for Information (RFI) was an opportunity to improve to guide us towards success.

Three years later, we have successfully maintained a program following best practices within the organization. We strive for continuous survey readiness because we learned a very hard lesson. While falling hard is rough on everyone, learning from those mistakes and implementing solid processes helped our program become even better than we could have imagined.

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute and
Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital

To demonstrate standard compliance for the inspector, each department maintains a shadow notebook to allow for an efficient and smooth review of evidence. The shadow notebook is comprised of tabbed sections of each standard applicable for a department, including a title page and any supporting documents behind the corresponding tab. During our past two accreditation cycles, our program found the shadow notebooks immensely diminished time spent paging through documents. The shadow notebooks eliminate the need to visit multiple sources, specifically in situations when a standard impacts more than one area of the program. A key factor for the development and organization of the shadow notebooks is consistent mock FACT inspections with physician leadership and individual department quality designees.

FACT mock inspections are scheduled with all program departments to provide a format to meet collectively to review all FACT standards. The collective review of the FACT standards allows time for brainstorming and discussion of standard implications across various areas of the program.

Do you have any example approaches for maintaining compliance with the various standards?

Melissa Henson BS, RN, OCN, Manager, Cellular Therapy and Leukemia Program, The Blood and Marrow Transplant/Leukemia Program, Northside Hospital Cancer Institute and
Ashlee Holbein, RN, FACT/QI Coordinator, The Blood and Marrow Transplant Program at Northside Hospital.

FACT standards are at the forefront of any discussion regarding updating a process or procedure. The first question is always, “What does the FACT standard say?” Daily, weekly, monthly, quarterly, and annual audits are used to ensure compliance throughout the accreditation cycle. Certain key standards are incorporated into quarterly programmatic quality improvement meetings to provide an overview of compliance to the program.

Richard Makin, Immune Effector Cell Quality Manager, The Children’s Hospital at Westmead Blood and Marrow Transplant Service

Our routine audit cycle focuses on standard FACT topics and is expanded to assess the implementation of new requirements. When new standards are published, we do a gap analysis against our current SOPs and processes. We do this informally when FACT circulates the drafts and formalize when active.

In summary:

Continuous readiness is the goal of all organizations, which means that 1) actual practice matches what is in the approved policies and procedures and 2) there is a mechanism, such as an audit, to verify implementation. It is critical that programs build systems that assure that compliance can be maintained with accreditation standards on an ongoing basis. A common theme from the suggestions is including the FACT Standards as part of discussions on a quarterly, monthly, and daily basis. Regularly looking at the FACT Standards while discussing new processes and procedures allows an organization to address issues and act on them in a timely manner.

Tools available on FACT’s web page:

When a new edition of the Standards is implemented, the FACT web page at http://www.factwebsite.org/standards/ is updated to include a summary of the changes from the previous edition.  Also posted on this site are updated documents such as document submission requirements and other self-assessment tools.

In the webinar, Using an Electronic Platform for Accreditation Preparation and Continuous Readiness, presenters provided step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness or as a platform to deliver evidence to the FACT inspection team. The webinar is available at http://www.factweb.org/forms/store/ProductFormPublic/using-an-electronic-platform-for-accreditation-preparation-and-continuous-readiness-webinar.


How to Access the FACT Accreditation Report with Program Responses

Posted in :: 2020 Volume 9 :: Friday, December 11th, 2020

Some commercial cellular therapy product manufacturers may provide FACT-accredited programs the option to undergo a full site quality audit or provide a copy of the most recent FACT accreditation report and undergo an abbreviated audit. If choosing the second option, programs will want to provide manufacturers the final report complete with program responses to cited deficiencies. Program responses are an opportunity to demonstrate correction of deficiencies and ultimate compliance with FACT Standards.

FACT Accreditation Coordinators will provide a copy of the final Accreditation Report, with the program’s responses, when sending the Accreditation Certificate at the conclusion of the inspection and accreditation process. Additionally, in the current online accreditation portal, the complete report can be downloaded by opening the applicable Compliance Application and clicking “View: Accreditation Report” in the left navigation pane. A version of this report is also automatically saved in the Document Library when the accreditation process is complete.


Accessing the Accreditation Report in the legacy FACTWeb Portal

Not all programs have completed the accreditation process in the current online portal. For these programs, contact your FACT Accreditation Coordinator, who will be happy to email you a copy of the report.

Read more about the FACT Accreditation Report


FACT Virtual Inspections in Response to COVID-19

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

FACT plans to begin virtual inspections this fall. There are many details to be finalized, however, the FACT Board of Directors has approved the plans outlined below. Thank you in advance for your flexibility and patience as we undertake this new process to protect the safety of our volunteer inspectors, personnel at accredited programs, and patients.

Eligibility for Virtual Inspections

Situations eligible for a virtual inspection include:

  • Renewal accreditation inspections of clinical, apheresis, or cell processing programs applying independently or together as a hematopoietic cell transplantation program, including immune effector cells.
  • Add-on service involving an existing accredited program (such as immune effector cells [IECs] or more than minimal manipulation processing).
  • Reinspection of all or a portion of a program following Accreditation Committee review of an in-person inspection, provided at least one member of the original inspection team participates in the virtual inspection, and there were no citations related to the physical integrity of the location itself.

Situations not currently eligible for a virtual inspection, and for which an on-site inspection is required, include:

  • Initial accreditation
  • Addition of an entirely new service in a new space, such as a pediatric program at a Children’s Hospital being added to an existing accredited adult program in another facility or a new current Good Manufacturing Practices (cGMP)-compliant processing facility added to an accredited transplant program.

In general, inspections will be either virtual or on-site, not a mixture. There may be exceptions. For example, an add-on to an existing program that is in the renewal process could have a virtual inspection for the renewal portion and an on-site visit of only the add-on portion (e.g., a cGMP facility for IECs added onto an accredited transplant program).

FACT is also working toward resuming some prioritized on-site inspections where these can be done in compliance with state, local, and CDC guidance and within facility and inspector restrictions.  This applies primarily to new applicants.

Prioritization of Virtual Inspections

Priority for virtual inspections will be given to cellular therapy programs whose on-site inspections were canceled, then to those who were in the process of scheduling when the on-site inspections were suspended in March 2020. Cord Blood Banks will begin virtual inspections slightly later.

All programs have been given an additional 6-month extension of their accreditation expiration dates as we resume inspections in this new way. This represents a total of a one year extension to the accreditation expiration.

Preparing for Virtual Inspections

Programs will receive direct individual communications regarding additional documentation that will be required either as an extra annual report or additional pre-inspection updates, depending on where they are in the accreditation cycle.

Please watch for communication from your FACT Accreditation Coordinator. You may contact your FACT Accreditation Coordinator for additional information and share this information with other appropriate individuals in your program, including apheresis and cell processing services. Your Accreditation Coordinator’s contact information can be found at http://www.factwebsite.org/About_FACT/FACT_Staff.aspx.

If you do not know who your coordinator is, contact Suzanne Birnley, Manager of Accreditation Services at suzanne.birnley@unmc.edu.

The Virtual Inspection Process

The platform for the interactive virtual inspections will be a FACT HIPAA-compliant ZOOM Healthcare account. There will be video tours expected, however, inspections will not be recorded. Video tours and additional documentation will be submitted through the FACT Accreditation Portal.

Cellular Therapy Program inspections will most likely occur over two days to allow both inspectors and program staff additional time to review and prepare additional documentation.

The Virtual Inspection Task Force is finalizing:

  • The list of additional documents that will be submitted in advance.
  • A list of documents that the program must be prepared to show to the inspector via ZOOM shared screen, which may include electronic documents such as SOPs, a portion of the EMR, or other scanned documents. Paper records may be shared via scanning or document or portable camera.
  • A list of items that will be demonstrated via a video tour of each site.
  • A proposed inspection agenda, including additional persons to be interviewed during the inspection, such as staff nurse, pharmacist, ICU / ER physician or staff.

Confidentiality of the Virtual Inspection

FACT has a Business Associate Agreement in place with each accredited and applicant program to cover confidentiality issues, including protected health information that may be viewed as part of the accreditation process, but is not recorded or retained by FACT or its volunteers.  FACT’s legal counsel has determined that the current Business Associate Agreement is sufficient to safeguard the virtual inspection process. FACT will work with any institution individually if there are concerns. All FACT staff and volunteers annually sign Confidentiality and Conflict of Interest Agreements.

In addition, the virtual inspection process will incorporate practices to enhance confidentiality, such as requirement for a private room for the inspector to conduct the inspection and lack of recording of the inspection.

Frequently Asked Questions

In addition to questions directly related to accreditation, FACT continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is periodically updated and is available on the FACT website. Topics include:

  • Rescheduled inspections
  • Renewal process
  • Allogeneic transplant numbers
  • Relocating transplant patients
  • Deviations
  • Care adjustments related to COVID-19

If you have further questions or concerns, please contact Dr. Phyllis Warkentin [phyllis.warkentin@factglobal.org or 402-559-6781],  the FACT office (402-559-1950), or your FACT Accreditation Coordinator.

Other Resources Available:

ASTCT Resources
WMDA Resources
Centers for Disease Controls
World Health Organizations
NMDP/BeTheMatch


FACT Accreditation Reports Promote Internal Improvement and External Confirmation of Quality

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

FACT accreditation is a credential that has its greatest value in the peer-to-peer exchange of ideas to confirm and improve quality in patient care and laboratory services. Successful accreditation is awarded with two tangible items: an Accreditation Certificate and a final Accreditation Report. Although the certificate gets more prominence, often framed and mounted as a visual symbol of quality, the final report is a detailed accounting of what accredited programs implemented to reach compliance with all FACT Standards.

Each Accreditation Report provides important information related to an accredited program’s journey to initial or renewal accreditation. The final report includes:

  • The name and location of the program
  • The date of the on-site inspection
  • The clinical, collection, processing, and/or banking sites and services associated with the accreditation
  • Key personnel
  • Identification of the FACT inspection team
  • A description of the program
  • Deficiencies and variances cited by the inspection team and approved by the Accreditation Committee
  • Required responses to provide evidence of correction of each deficiency or acknowledgement of each variance
  • The program’s responses documenting completion of corrective actions and compliance with Standards
  • FACT’s response, or determination regarding the adequacy of the program’s corrective action
  • Details of any additional follow up reports or documentation due to FACT

After completing the rigorous accreditation process, programs may debrief the contents of the Accreditation Report and then file it away, turning attention to its many other important duties until annual reporting is required. However, the final report is a valuable tool that can be used throughout the accreditation cycle.

Internal Improvement

Programs that have corrected deficiencies and submitted adequate evidence of correction and compliance with standards should be very proud of the work they have invested into improvement. Lessons learned throughout this process can be applied to the entire program. For example:

  • How will we evaluate our corrective actions to confirm long-term effectiveness?
  • What other strengths and weaknesses did we discover while correcting deficiencies?
  • Are there further root cause analyses we should perform to prevent similar deficiencies?
  • Can we apply the same process to evaluate other aspects of our program?

Ideas generated from this review of the Accreditation Report may be useful to maintaining the Quality Management program via audits, process development, personnel training, and other quality concepts.

External Confirmation of Quality

Apheresis collection facilities, cell processing facilities, and clinical services are each important in the context of blood and marrow transplantation, where accreditation covers the entire scope of the therapy from patient selection and treatment, through product selection, collection, processing, and administration. These same services participate in clinical trials often including products developed and manufactured by industry partners. These facilities recognize the importance of standards, have achieved voluntary FACT accreditation, and have played a major role in delivering new products to patients. They have used their quality programs and processes to quickly adapt to increasing numbers of products, procedures, and manufacturers. However, facilities have individually and collectively expressed concern regarding the growing number of on-site audits. The increased burden of preparing for, participating in, and responding to audits requires more resources to be diverted to these activities rather than toward patient care.

Commercial manufacturers who produce cellular therapy products for clinical trials or under an approved regulatory license may wish to leverage FACT accreditation to streamline audit activities, verify quality practices, and reduce the burden on health care entities. To do this, manufacturers may request a copy of the final FACT Accreditation Report. FACT does not provide Accreditation Reports to any entity except the accredited program. Accredited programs are not restricted from sharing these reports and may choose to provide them to manufacturers leveraging FACT accreditation, however, they are not required to do so.

Accredited programs or their hospital administration may be hesitant to disclose deficiencies cited during an on-site inspection. However, FACT accreditation is a voluntary, peer-based quality improvement process, during which  some deficiencies can be expected at any program. The documented deficiencies demonstrate the rigor of the inspection process. The final report includes the description and documentation of the program’s corrective action, FACT’s determination of the adequacy of the response, and any additional follow up that may be indicated.  Responses to deficiencies are an opportunity to proudly share a program’s process improvements. Programs should inquire of any commercial manufacturer regarding the confidentiality of information they provide to increase confidence in the use of the FACT report.

If a program chooses to provide the final Accreditation Report to a commercial manufacturer, it will likely be able to participate in an abbreviated site audit because the Accreditation Report can be used to confirm the quality systems in place meet FACT Standards. If a program chooses not to provide the report, it may be required to undergo a full site audit that will include requirements duplicative to the FACT Standards.


SAVE THE DATE: FACT Announces Virtual Inspection & Accreditation Workshop

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020


FACT Inspections Amid the Pandemic

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

FACT is eagerly anticipating resumption of accreditation activities. In March 2020, FACT suspended on-site inspections and extended all accreditation deadlines and expiration dates by six months due to the COVID-19 Pandemic.  During this time, FACT staff have continued to review submitted applications and responses, prepared and presented educational webinars, and facilitated the vital committee work in standards development, accreditation, quality, clinical outcomes, data audits, education, immune effector cell initiatives, and international accreditation support.

Although the pandemic is not over, some travel has resumed, and some institutions are opening elective procedures and in-person visits. A FACT Task Force will determine the best approach to resumption of on-site inspections. Options include virtual inspections, in-person inspections associated with limited travel, or a combination of methodologies. Factors to be assessed include inspector availability, inspector ability to travel, openness of institutions to non-essential individuals, and characteristics of the applicant program such as prior accreditation and the time remaining until accreditation expiration. Inspector availability and on-site options are being assessed through a survey distributed to inspectors and Program Directors. FACT will publish periodic updates related to inspections through the Newsletter and email communications.


FACT COVID-19 Resources

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

 

 

 

 

 

COVID-19 Update: FACT Accreditation
The health and safety of our cellular therapy community continues to be our utmost concern as we all work to mitigate the effect of the COVID-19 pandemic.

On-site Inspections Postponed
FACT has postponed all scheduled on-site inspections until there is more information available about the timeline of this pandemic.

  • Rescheduling of these and additional inspections will resume when an appropriate timeline can be determined.
  • No accreditation will lapse due to delays and postponements related to COVID-19.

Accreditation Extension
Effective immediately, the accreditation expiration date for all FACT-accredited organizations will be extended by six months, regardless of the current expiration date. This includes all:

  • Clinical hematopoietic cell transplant programs
  • Immune effector cell programs
  • Apheresis centers
  • Laboratory facilities
  • Cord blood banks

This is our current best estimate of an appropriate timeline, however, if circumstances warrant, additional extensions will be implemented. New accreditation certificates will be prepared and distributed to eliminate confusion. The official list of accredited organizations is available on the FACT website. To the extent possible, programs should continue to submit documents and complete Compliance Applications during this period when on-site inspections are not being scheduled.

FACT staff are available by phone or email to review this information, and provide other assistance as needed.

Frequently Asked Questions
FACT continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is available on the FACT website. Topics include:

  • Rescheduled inspections
  • Renewal process
  • Allogeneic transplant numbers
  • Relocating transplant patients
  • Deviations
  • Care adjustments related to COVID-19

If you have further questions or concerns, please contact Dr. Phyllis Warkentin (402-559-6781), or the FACT office (402-559-1950)

Other Resources Available:
ASTCT Resources
WMDA Resources
Centers for Disease Controls
World Health Organizations


SBTMO meeting at TCT

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

FACT Board members met during the TCT Meetings with its newest accreditation partner, Sociedade Brasileira de Transplante de Medula Óssea  (SBTMO) to continue planning to assist Brazilian transplant centers to achieve FACT-SBTMO Accreditation.

Andrea Kondo, who is a member of SBTMO and is part of the Accreditation Committee, was responsible for presenting to the Latin American Bone Marrow Transplant Group (LABMT) during the TCT Meetings the steps already taken in the FACT-SBTMO Accreditation Program. Dr. Kondo announded there are already 24 hematopoietic stem cell transplant centers that want to participate in the program and achieve certification. This is because “the accreditation attests to the institution that it offers safety, excellence and quality in each of the processes practiced by it, not only in the part of the clinical program, but also in the collection of progenitor cell products, in the processing and infusion of cells -trunk, ”explains Andrea.

“These centers that have already joined and the others that have been contacting us, show us that there is really a movement to strengthen and improve our HSCT practice, which is a gain not only for services, but especially for patients” declared the president of SBTMO, Nelson Hamerschlak.

It is worth mentioning that Brazil was the pioneer in Latin America, since 2012, to gain FACT recognition, through the accreditation of Hospital Israelita Albert Einstein (HIAE), which has been re-accredited in 2015 and 2018.

Educational efforts to support the Brazilian centers in preparing for accreditation are underway. Andrea Kondo is currently working on the development of educational tools and webinars to assist transplant centers. Planning is underway for a FACT Inspection & Accreditation workshop scheduled to take place during the SBTMO Annual Congress slated for October 2020 in Sao Paolo.


FACT Exhibit Booth at TCT: Meet and Greet with Accreditation Services Leaders!

Posted in :: 2020 Volume 1 :: Monday, January 27th, 2020

FACT invites you to visit exhibit booth 733 to meet the leaders of Accreditation Services and have your accreditation and standards questions answered!

On Thursday, February 20, FACT Accreditation Supervisor, Sarah Litel-Smith, will be available at the FACT exhibit booth from 12:00 pm – 2:00 pm

 

On Friday, February 21, FACT Accreditation Manager, Suzanne Birnley, will be available from 7:00 am – 9:00 am.

 

 

 


Online List of Accredited Organizations Can Now be Downloaded

Posted in :: 2019 Volume 11 :: Monday, November 25th, 2019

The official list of FACT-accredited organizations is the online version available via the FACT website. This online list includes many features that allow users to search for programs with specific criteria.

We are happy to announce that the website now allows users to download the entire list of accredited organizations. A download button is available at the top of the screen, and will download the list in Excel format. All of the details available online are also included in the Excel file. The download data updates every hour.

It is important to emphasize that the online listing is the official version. If there is ever a discrepancy, the online listing prevails.


FACT Accreditation Used as Criterion in Best Hospitals List

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

U.S. News and World Report released its 2019-2020 Best Hospitals List, and FACT accreditation was again used as a ranking criterion for the cancer specialty. Since 2007, accredited programs receive a point value based on their accreditation.  One point was given if accreditation was only for autologous transplants, and two points were given if accreditation was for allogeneic transplants. All 50 hospitals with rankings in the cancer specialty have programs that are FACT-accredited. Congratulations to these programs!

View the list of best hospitals in the cancer specialty


FACT Accreditation a Criterion for 2019-2020 Best Children’s Hospitals List

Posted in :: 2019 Volume 7 :: Monday, July 29th, 2019

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 Children’s Hospitals list, one point was given for the Cancer specialty if a hospital is FACT-accredited as a pediatric or adult service provider for either autologous or allogeneic transplants. Congratulations to these hospitals!

See list of Best Children’s Hospitals
Review ranking methodology


Education Events

Posted in :: 2019 Volume 7 :: Monday, July 29th, 2019

FACT-SBTMO Cell Therapy Accreditation Workshop
July 31, 2019
Brasília, Brazil

This training workshop is designed to explain the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
• Provide an overview of the FACT Standards and accreditation process
• Explain how to integrate quality management into clinical, collection, and cell processing programs
• Examine how to prepare for a successful inspection
• Summarize how controlling documentation can improve your program
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions

This workshop is from 8:00 to 13:15 on Wednesday, July 31, 2019.

View meeting details and register 

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

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

  • WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
  • FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!

View meeting agenda

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This workshop in Madison incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy. Several hot topics include quality management in novel cell therapies, environmental monitoring, and occurrence management. These sessions are designed to help applicants navigate the evolving changes in the field. The agenda also includes training for new inspectors with real-world examples and exercises to guide them through the inspection process. This is a must-see event for the following audiences:

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

The day includes an applicant track and inspector training track. Inspector trainees are required to attend the inspector orientation track.

We encourage programs to send multiple personnel to attend the various FACT events on September 12.  The FACT Cellular Therapy Inspection and Accreditation Workshop is a must-see for cell processing laboratories, physicians, scientists, and principal investigators, and unit supervisors, laboratory managers, administrators, nurses, and medical technologists.  The ISCT-FACT Quality Boot Camp, which takes place on the same day as the workshop, is essential for program quality managers.

View meeting details and register
View meeting agenda

ISCT-FACT Quality Boot Camp at the 2019 ISCT North America Meeting
September 12, 2019
Madison, WI

Is your lab FACT accredited or looking to comply with FACT standards? Strengthen your quality management programs through this interactive workshop with FACT experts and real world applications.

Focused on issues identified by FACT compliant programs, these sessions will include activities and discussion regarding Document Control, Risk Assessment in the Processing Laboratory, Supply Qualification, and Audit Plans and Writing the Report. Come prepared with your quality program questions and leverage QA experts to apply continuous improvement to your own institution. This boot camp is applicable not only to academic labs but also relevant for commercial operations.

We encourage programs to send multiple personnel to attend the various FACT events on September 12. The ISCT-FACT Quality Boot Camp is essential for all quality and laboratory personnel. The FACT Cellular Therapy Inspection and Accreditation Workshop, taking place on the same day, is a must-see for Cell processing laboratory personnel, physicians, scientists and principal investigators, administrators and nurses.

View details and register now
View preliminary agenda

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 2
September 25, 2019
Webinar

The second webinar in this two-part webinar series will be on Thursday, September 25, 2019 at 11:00 am ET. Part two includes information from Dr. Joseph Alvarnas from City of Hope. Dr. Alvarnas will give his perspective as a hospital administrator in regard to the following:

• Agreements with Manufacturers
• Reimbursement

View meeting details and register 

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register 


Education Events

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

Using an Electronic Platform for Accreditation Preparation and Continuous Readiness Webinar
Wednesday, June 26, 11:00 am ET
Webinar

This webinar will be on June 26, 2019 at 11:00 am ET and is FREE OF CHARGE. Trisha Deason, MHA, MSN, RN, NE-BC, Eryn Draganski, AGCNS-BC, OCN, and Jay Maningo-Salinas, PhD, RN, NE-BC, CPHQ, FACHE, from Mayo Clinic Arizona, have graciously agreed to share their tool designed in Microsoft OneNote to be used for continuous readiness and compliance with FACT requirements.

Collecting supporting evidence for accreditation standards can be a daunting task and include a tremendous amount of resources (e.g., paper, binders, charts). Workflows may be inefficient if duplication of efforts occurs across personnel and departments. Use of an electronic source provides an updated mechanism to gather, retain, and share evidence, as well as an organized approach to present all supporting documents to on-site surveyors. Presenters will provide step-by-step instructions on how to build a OneNote FACT e-binder and organize evidence to be used for continuous readiness and/or as a platform to deliver evidence to the FACT survey team.

View meeting details and register online

ASGCT-ASTCT-FACT Webinar: Centers’ Experience with Implementing Commercial CAR T-cell Products – Part 1
Thursday, July 25, 11:00 am ET
Webinar

The first webinar in this two-part webinar series will be on Thursday, July 25, 2019 at 11:00 am ET.  Part one includes information from two centers regarding their journey to successful implementation of commercialized CAR T-cell products. Clinicians will address the challenges faced during the site on-boarding process, where they are in the process, commonly faced impediments to timely delivery of therapy to patients, and suggestions for centers initiating implementation of commercial CAR T-cell products. Topics in this webinar will include required training, maintenance of chain of custody, and mechanisms for reporting outcomes data. FACT accreditation will also be covered.

This is part one of two in the Centers’ Experience with Implementing Commercial CAR T-cell Products series.  Part two will take place in September of 2019 and will include the perspective of a hospital administrator in regard to the following:

  • Agreements with Manufacturers
  • Reimbursement
  • FACT accreditation

View meeting details and register

FACT-SBTMO Cell Therapy Accreditation Workshop
July 31, 2019
Brasília, Brazil

This training workshop is designed to explain the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
• Provide an overview of the FACT Standards and accreditation process
• Explain how to integrate quality management into clinical, collection, and cell processing programs
• Examine how to prepare for a successful inspection
• Summarize how controlling documentation can improve your program
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions

This workshop is from 8:00 to 13:15 on Wednesday, July 31, 2019.

View meeting details and register 

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

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp track, and a FACT Inspector Training Track. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

  • WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
  • FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!

FACT Cellular Therapy Inspection and Accreditation Workshop at the ISCT North America 2019 Regional Meeting
September 12, 2019
Madison, WI

This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs. FACT representatives will be in attendance to clarify the intent of the FACT-JACIE Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.

Two tracks are available for this workshop. The Inspector Track will provide FACT inspectors guidance on how to assess compliance with the Standards. The Applicant Track will give programs and facilities insight into how to comply with the Standards and demonstrate compliance.

View meeting details and register

Significant Changes to the Seventh Edition NetCord-FACT Cord Blood Standards
October 23, 2019
Webinar

This presentation will be on Wednesday, October 23, 2019, at 11:00 am ET. Paul Eldridge, PhD, Director of Cell GMP Facility at UNC Bone Marrow Transplant and Cellular Therapy Program, will describe significant changes to the Seventh Edition NetCord-FACT Cord Blood Standards, and provide examples for effective implementation.

View meeting details and register 


The Countdown is on to Register for FACT Events at the ISCT Annual Meeting!

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

Register Now and Save!

FACT Accreditation Workshop
Join your fellow cellular therapy and cord blood colleagues for several FACT events at the 2019 ISCT Annual Meeting in Melbourne, Australia.  On May 28th FACT will host a Cellular Therapy and Cord Blood Inspection and Accreditation Workshop from 8:00 am to 5:00 pm.  This workshop incorporates instruction on the process of accreditation, FACT Standards requirements, and practical applications such as risk assessment and transportation issues related to cellular therapy and cord blood banking. Several hot topics include quality management in novel cell therapies, written agreements, and occurrence management.  Register before May 28th and save $100!

Fees are waived for active and trainee inspectors.  Apply to volunteer and train as a FACT inspector.

ISCT-FACT Quality Boot Camp
On May 29th ISCT and FACT will host a cellular therapy Quality Boot Camp for sessions that include activities and discussions addressing the following: IECs in Your Organizations Quality Plan and Written Agreements, Document Control, Performing Risk Assessment: Real Life Applications, Process Validation 101, and Evaluating and Reporting Audit Results. Register online for the ISCT Pre-Conference Day and attend the ISCT-FACT Cellular Therapy Quality Boot Camp! Note: ISCT Pre-Conference Day registration requires separate registration from the main ISCT Annual Meeting.

FACT Exhibit Booth
FACT representatives will be at exhibit booth #36 to provide information about FACT Standards and Accreditation. We would love to see new and familiar faces!

Exhibit Booth Dates and Times:

Wednesday, May 29th: 19:30 – 21:30
Thursday, May 30th: 09:00 – 19:30
Friday, May 31st: 09:00 – 18:30

Take advantage of these exciting FACT events by registering now! We look forward to seeing you in Melbourne!

 


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

Posted in :: 2019 Volume 5 :: Friday, May 17th, 2019

The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp, and FACT Inspector Training. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.

Topics will include:

  • Global perspectives of the regulation of cord blood banking,
  • WMDA serious adverse events and reactions,
  • Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
  • Analysis of cellular viability in thawed cord blood,
  • Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
  • Essential Quality Management Principles

The afternoon offers two tracks:

  • WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
  • FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.

This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!