Just the FACTs, 2020 Volume 7

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

Dear Colleagues,

I am really struck by the universal importance of hope in the setting of information (read truth), and I encourage you to read the article by Dina Becirovic, one of FACT’s Accreditation Coordinators. And when we think about giving our patients the best chance, Louis Pasteur is credited with “chance favors the prepared mind”—and prepare we must, for it is our preparation and systems that give complex care the best “chance” of success.

We celebrate Apheresis Awareness Day today (as I write this) and recognize World Marrow Donor Day, thanking the thousands of unselfish donors giving so others may have a better chance. Our apheresis teams are busier and busier, and donors of all kinds are needed for our ever-expanding population of transplant-eligible individuals.

Don’t forget to register and participate in our virtual workshop next week! Be sure to take advantage of the new way to network: upload a photo and information about yourself and send messages to other participants. I have a feeling we will do this more even when in-person meetings resume.

I know as another month has gone by you all have had one more month of handling the stresses of this reality. Child care challenges, two people working from home competing for the same space, internet speed, and airspace! Not to mention the irony of health-care workers furloughed during a health-care crisis, and the obvious stresses that induces. So, recognizing this, take a minute, breathe, and find an hour for yourself this week (I’d suggest more, but I have grandchildren three and under, so I know the odds of more than an hour are small). Without you the patients don’t get better. And one last request, think about and do whatever you can for everyone up and down the West Coast who have lost so much.

Take care!

Dennis Gastineau


Just the FACTs, 2020 Volume 6

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

Hi, Friends!

You have a week to get your comments in for the eighth edition FACT-JACIE Standards and the second edition IEC Standards. If you see issues, please submit your suggestions.

While many states in the U.S. still have rising COVID case numbers, others are showing clear signs of decreasing. Australia and New Zealand are working on more localized outbreaks, and, if there is anything to learn from New Zealand, it is that we are all in this together. The world is so small that everyone must do their part to care for each other.

See the article about the Professional Relations Committee on ways to help each other through these unusual times, and be sure to take advantage of all the educational events. A good way to keep everyone in your program up to the 10 hours of annual education!

As caregivers, I don’t need to tell you to take good care of everyone else, but take some time today to do two things: think of someone you haven’t spoken to in a while and make that contact; and consider one thing to be thankful for. I’ll start the second part: I’m thankful to be sitting next to my spouse of 44 years having just returned from a bicycle ride in the north woods of Wisconsin. What’s yours?

Sincerely,

Dennis Gastineau


Just the FACTs, 2020 Volume 5

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

Hello colleagues—as COVID becomes a marathon with no real end in sight, and Zoom and Skype are as personal as we get (and our conference rooms are all being used for social distancing), we all look for the pace and combination of communication techniques that allow us to remain in touch with one another beyond our purely professional relationships. The silver lining has been a tendency to try harder to communicate and talk to those we have always meant to call, and I urge each one of you to choose one of your friends this week to call, FaceTime, Zoom, or any way to be in touch and reduce the isolation they might feel and in so doing reduce your own.

We mourn the passing of one of the pioneers of our discipline, Roger Herzig, who was attending on his transplant service. Dr. Herzig was loved by his patients, his program colleagues, as well as colleagues around the world. We all send condolences to his wife and family.

We invite you to a virtual workshop for inspection and accreditation, and the Education Committee is working hard optimizing the virtual experience for you. And don’t forget to look at the 8th Standards and send in your comments by the end of August.

Our community has continued to provide transplant services to patients needing them, and volumes of transplants are remaining remarkably high with all the competing demands on hospital resources—tell each other how much you appreciate the creativity and dedication continuing such complex care, I know our patients feel the same.

I’m grateful to see so many colleagues working so hard in these times, but try to give yourselves a break and a little time to reflect on what you are grateful for.

Sincerely,

 

 

Dennis Gastineau, MD
FACT President


Just the FACTs, Volume 4

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

Friends,

First, may I recognize the fatigue everyone has by now, especially as we (at least in the United States and some European countries) are facing a rise in the number of COVID-19 cases again just as we try to reopen transplant services to our patients who so badly need them. Second, may we have kindness in our hearts as we strive for a just world, and the joint statement by FACT, ASTCT, CIBMTR, ISCT, and EBMT acknowledging and condemning racism is a step in that direction. As we pursue our daily activities may we see all people and situations through a new lens.

I think the ISCT meeting was very successful, even more remarkable because of the pivot from an in-person meeting to the new format in such a short time, and may be a sign of the future as we figure out how to communicate with one another, especially for people who have risk factors for complications of COVID infections.

Even as we physically distance, keep in touch with everyone, particularly family and loved ones, please wear masks (I’m preaching to the choir, but choir is one of the risky activities . . .) to protect one another.

Take care,

 

 

Dennis Gastineau, MD
FACT President


Just the FACTs, Volume 3

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

Hello to a changed world from the last time I wrote to you. As much as I’d like to talk about something else, everything we are doing is affected by COVID-19. You will see a lot of this newsletter deals with cancellations and delays. One silver lining from a programmatic standpoint is the six-month accreditation extension to all programs but that will fly by, I’m sure.

Practice changes are coming fast and the FACT FAQs are being updated frequently by Dr. Warkentin, please note the links for the FDA and always pay attention to the ASTCT for evolving clinical practice guidance. FACT is not determining these practice changes and there are not changes in standards as the practice evolves. The principles that the standards reflect remain the same.

Convalescent plasma is an exciting potential therapy for our patients, and I’m aware that our cell therapy teams have been integrally involved, from collecting plasma to making collection kit components in biosafety cabinets, so kudos to all who are stepping up/stepping outside their roles to help our patients.

Keep physical distancing and remember, just flattening the curve is like your parachute slowing you down, it doesn’t mean it’s time to take off your parachute at 5,000 feet, there’s still a ways to go . . . I’m sure I’m preaching to the choir, but keep your patients, your kids, your grandparents all safe while keeping yourself as safe as possible. To use one more simile, the canoe gets to its destination only if everyone paddles in the same direction. Let’s get our shared canoe through these rough waters paddling together.

Sincerely,

 

 

Dennis Gastineau, MD
FACT President


Just the FACTs, 2020 Volume 2

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

It was great to see many of you at the TCT meetings in Orlando (I didn’t pack a warm enough jacket!) where the solid emergence of cell therapies was in constant evidence. The Quality Boot Camp was another smashing success, as were the applicant and inspector training courses at the FACT Inspection & Accreditation Workshop, and the cellular therapy leadership courses. I had an opportunity to make a presentation on FACT Immune Effector Cell Accreditation to the administrative track, which evoked many questions, some showing the importance of educating our administrative colleagues in the importance of coordinated, comprehensive, quality-driven care to optimize outcomes for our patients and the role community-driven accreditation plays. We had a chance to express our thanks to Mark Litzow for his many years of service on the FACT Board of Directors and as the first FACT Technology Committee chair. You are already missed, Mark! Travel restrictions and meeting cancellations are coming at a rapid pace and paper goods are flying off the shelves as COVID19 cases increase. Our patients would be among the greatest affected—if you are ill take care of yourself and stay home for their sake.

Hand wave from greater than 6 feet—see you soon.

Dennis Gastineau, MD

 

 

 

FACT President

 


Just the FACTS, 2020 Volume 1

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

I am looking forward to seeing everyone at the Tandem, oops!, TCT meetings—some of us take longer to train than others . . . Lots of changes and new events, including a “Mingle with Mimosas” on Thursday for all inspectors to recognize our volunteer force while enjoying a continental breakfast . . . and mimosas! Thank you to everyone for all of your volunteer time, and for everyone else, please consider becoming an inspector. There are more personal and professional benefits from doing inspections than you can imagine.

Once again we are offering leadership training courses, both the original and now advanced courses and of course the Inspection and Accreditation Workshop on Tuesday with a new format. To attend the inspector track you must be pre-approved by the FACT office to be eligible to be an inspector, so register ahead. The Quality Boot Camp session will be on Wednesday to round out 24 full hours of FACT training opportunities at the TCT meeting.

Be sure to pay attention to the online educational offerings, particularly the new Immune Effector Cell Therapy Webinar series, 6 webinars in 2020 by colleague experts in the field.

Last, but certainly not least, remember the FACT Cord Blood Inspection and Accreditation Workshop at the ISCT Annual Meeting in Paris—if that location doesn’t get you there, nothing will. Again, if approved by the office as eligible to be a trainee, that course is free of charge.

Whew! So much to do in Florida, you may not need to bring sunscreen! See you all there!

Sincerely,

 

 

Dennis Gastineau
FACT President


Recently Published Book Includes Chapter on FACT Citations in Apheresis

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

The recently published book, Best Practices of Apheresis in Hematopoietic Cell Transplantation (Abutalib et. al., 2020), includes a large number of topics relating to the use and performance of apheresis in hematopoietic cell transplantation. The book is described as a practical resource for clinicians ranging from residents to faculty members and other healthcare personnel. The book is available for purchase in its entirety or by individual chapters.

FACT President Dennis Gastineau, MD wrote Chapter Three, FACT-JACIE Standards: Common Citations and How Best to Avoid Them. The chapter on citations focuses on deficiencies found in apheresis facilities during on-site FACT inspections. Dr. Gastineau briefly describes the citations and then suggests methods for avoiding them in future inspections.

Abutalib, S.A., Padmanabhan, A., Pham, H.P., Worel, N. (Eds.) (2020). Best Practices of Apheresis in Hematopoietic Cell Transplantation. Springer International Publishing. doi: 10.1007/978-3-319-55131-9.


Just the FACTs, Volume 11

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

To those of you in the Northern Hemisphere, the days are getting shorter meaning you obviously should be sleeping better—oh, I forgot, we’re transplanters so that’s not allowed. Well, drive carefully in the dark, while all our colleagues down south, enjoy the longer days for more golf—oh, I forgot, we’re transplanters so we probably don’t play golf.

Down to the real stuff, the CIBMTR committee on Infection and Immune reconstitution is doing important work to help us all learn more about post-transplant infections, one of the big opportunities for improvement of patient outcomes. The FDA Cell Therapy Liaison Meeting (CTLM) in March addressed a number of topics, one of which is the collection of MNCs that are then sent to outside companies for manufacturing. The variation of collections (which are really a part of the manufacturing flow, but that is another bone to pick) was raised, both technical issues and the patient issues affecting the cell quantities and therefore product effects was accepted as an important question by the FDA.

Lastly, I invite you to one or more of the FACT activities at the upcoming TCT meetings: The Inspection and Accreditation Workshop and Leadership courses are on Tuesday, February 18th, prior to the opening of the TCT conference, and the Quality Boot Camp is on the 19th, the TCT pre-conference day. On the 20th there will be a gathering for International Delegates hosted by the FACT Global Affairs Committee. We look forward to seeing you at one or more of these in 2020!

Enough for now, I have to go change the battery in my headlamp . . .

Sincerely,

 

 

Dennis Gastineau, MD
FACT President


Just the FACTs, Volume 10

Posted in :: 2019 Volume 10 :: Thursday, October 31st, 2019

Have you finished your holiday shopping yet? I cannot believe the year has gone by so quickly.

This month’s central theme of data management and its importance is crystalized by the potential penalty of poor CIBMTR audit outcomes and potential impact on accreditation. Why is “just data” so important to accreditation? Well, without correct data, no program or program director can know what is going on in the program beyond gut feel (and we know how that works out . . .).  The correct data is not merely to ensure CIBMTR has good data for research, it is so each program can be performing effective ongoing self-analysis for continuous improvement of the care of patients and outcomes. Therefore, it is time to ensure that everyone in the program is participating in the quality of information, from the clinical note, to abstraction, to understanding the questions and categories for CIBMTR. That alone takes a teamwork of providers and data managers.

FACT continues to expand its Regenerative Medicine activities and note the article on Advanced Therapies Week in January.

A big thank you to all who performed their first inspections this year—keep recruiting your colleagues! We have some new programs for supporting and educating inspectors to ensure everyone feels comfortable going out for that first inspection, and resources to access before, during, and after the inspection. Keep it up!

Sincerely,

 

 

Dennis Gastineau
President of FACT


Just the FACTs, Volume 9

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

Suddenly the days are shorter than the nights and even in Arizona, the days are getting cooler. The fall Regional Meeting for ISCT was well attended, including non-HPC trial investigators, and the opportunity for networking was welcomed by our technologists. Once again the Quality Boot Camp was extremely popular, a joint effort by FACT and ISCT. It’s yet another reminder that FACT’s parent organizations are both major forces in traditional hematopoietic cell transplantation as well as non-HPC cell therapies. The next opportunity to see this is at the TCT meetings, and you will find the schedule of FACT-related activities at that meeting in this newsletter.

Unlike fall days, cell therapy is definitely NOT cooling down. Job offers abound for those with almost all of the skills that we have in the cell therapy community, from quality to processing to collection and clinical care. This means there is turnover (and some of us are even retiring after 30 or 40 years in the field), and so we need to constantly welcome new colleagues and help them with their education and the philosophy of the best for the patient and constant improvement.

Just like a good cell therapy program, FACT is constantly undergoing self-evaluation, and the board will be meeting for a tune-up of the focus of our strategic plan, as there are so many opportunities coming so quickly, that figuring out what we have the capacity to do and what new projects deserve prompt attention needs to be done more often than every five years.

In addition, we constantly look to volunteers to add to our inspector list, and you will read about Cord Blood Inspector recruitment, but no matter your expertise, FACT can probably use your time and effort, whether in cord blood, bone marrow transplant, or immune effector applications. As we look to the next decade (yes, another one goes in the books soon) we look to a myriad of cell therapy opportunities and activities. Join the ride!

Sincerely,

 

 

Dennis Gastineau, MD
FACT President


Just the FACTs, Volume 8

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

This summer has been busy with travel! FACT staff made a trip to Brazil to launch the FACT and Brazilian Society of Bone Marrow Transplant (SBTMO) Joint Accreditation Program, and also found their way to Barcelona, Spain where the FACT-JACIE Standards Steering Committee initiated the development of the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration.  Soon, FACT representatives will land in Paraguay for the Worldwide Network for Blood & Marrow Transplantation (WBMT) meeting where they will conduct a half-day work workshop on FACT-JACIE accreditation.

Articles in this issue include:

I hope you all had a wonderful summer and I look forward to seeing many of you throughout the rest of 2019!

Sincerely,

 

 

 

Dennis Gastineau, MD
FACT President


Just the FACTs, Volume 7

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

I am just going to assume that wherever many of you may be, you either are or have been hot and sticky this month. Despite the heat, there are some cool things going on.

First, I recently finished performing my first inspection with the new portal. Both inspectors and programs who have not used it yet are in for a treat. Far faster response times allow you to review much more data in much less time. I chatted with the program’s frontline folks, and they said the uploading was much better as well. I am confident you will have a reaction similar to mine when you are next scheduled to inspect.

Second, in this newsletter you can read about the Clinical Outcomes Committee process (and you might even want to read the whole journal article!). The process has evolved to the point that both the FACT office and the committee are able to give a great deal of guidance to programs as they look to improve their programs and thereby the outcomes for their patients. From humble beginnings, Michael Lill took the committee to a much more sophisticated and helpful level. That evolution continues today.

Join us in this continued progress and support of cellular therapy programs!

Dennis Gastineau, MD

FACT President


Just the FACTs, 2019 Volume 6

Posted in :: 2019 Volume 6 :: Friday, June 14th, 2019

I recently arrived back from Melbourne and the International Society for Cell & Gene Therapy annual meeting. I would like to give a special thank you and recognition to Ngaire Elwood, FACT vice-president, one of the main organizers of this meeting of one of our two parent organizations. Patrick Hanley, PhD, chair of our Education Committee, chaired sessions and presented, as did many other FACT patrons! The breadth and depth of cell-based therapies is truly astonishing, and FACT is actively participating to assure the best possible products are delivered to our patients every day. I use the term “our” because FACT board members and inspectors are all active members of transplant, cord blood banking, and immune effector cell programs.

We had successful FACT training workshops and another excellent Quality Boot Camp in the days leading up to the meeting. For those who were unable to attend the annual meeting, the ISCT Regional Meeting in North America will be held in Madison, Wisconsin from September 12th – 15th.   Join us for the FACT Cellular Therapy Inspection and Accreditation Workshop on Thursday, September 12.

Articles in this issue include:

  • FACT Events at ISCT Were a Success!
  • Help FACT Design Education Just for YOU
  • Comments Requested About Needed Standards for Regenerative Medicine
  • Webinar Series on Implementing Commercial CAR T-cell Products
  • The Standards Coordinating Body Gives You a Voice
  • New CARTOX App Assists Grading and Management of IEC Toxicities
  • ASFA Releases Updated Practice Guidelines for Therapeutic Apheresis
  • June is Cancer Immunotherapy Awareness month
  • FACT Educational Opportunities

Sincerely,

Dennis Gastineau, MD
FACT President

 


Just the FACTs, 2019 Volume 5

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

It’s hard to believe that we’re nearly half way through the year; in seven months we begin “the 20’s!” In this month’s newsletter, you will see FACT’s upcoming worldwide activities!  We hope to see many of you soon at the FACT workshop and quality boot camp at the ISCT annual meeting in Melbourne on May 28th and 29th.  In June, FACT visits our colleagues in the north to host an accreditation and inspection workshop at the Canadian Blood and Marrow Transplant Group (CBMTG) meeting. July brings a trip to Brazil where FACT will host another workshop at the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) Meeting. As summer winds down and we head into September, FACT is excited to hold a special cord blood day with the WMDA-NetCord Cord Blood Working Group at the second annual Cord Blood Connect International Congress in Miami. Also in this issue you, is an article on inspector recruitment, and I  encourage each of you to be recruiters for FACT and the community. Simply tell your story of all you derive from visiting programs including, networking, examples of practices to adopt, and intimate familiarity with the FACT Standards. As always, every season is Standards season, and FACT is preparing to publish the seventh edition of the Cord Blood Standards on October 15, 2019.

I’m preparing for an inspection in the new accreditation portal this month, and I think you will find the portal intuitive, fast, and consistent. I’m really pleased with it, and I hope you will be too.

Articles in this issue include:


Just the FACTs, 2019 Volume 4

Posted in :: 2019 Volume 4 :: Wednesday, April 17th, 2019

Many of you in North America are tired of winter and cold, and we have some hot topics in this newsletter to get your circulation going. One topic is FACT’s contribution of comments to the CMS national coverage determination for CAR T-cell therapies. We hope the coverage will be clarified in a manner that covers the costs to the institution beyond the purchase of the product. Also, I invite all of you to consider volunteering for the Standards Committee for the upcoming revision cycle. This is very much a working committee, but there is no better way to know what’s coming and contribute to the community than through the making of clinically important standards!

As always, there are many educational events throughout the year. Review FACT’s educational calendar and register for an event today.

I look forward to seeing many of you at the ISCT Annual Meeting in Melbourne!

Articles in this volume include:

Sincerely,

Dennis Gastineau, MD
FACT President


Just the FACTs, 2019 Volume 3

Posted in :: 2019 Volume 3 :: Thursday, March 14th, 2019

In this issue, we congratulate Dr. Paul Eldridge, FACT Standards Chair, and the Common Standards Steering Committee on publishing the Second Edition of the FACT Common Standards for Cellular Therapies.  The Standards become effective on June 15, 2019.  Read more regarding the publication of the Common Standards and accessing the Summary of Changes, Crosswalks, and Document Submission Requirements form below.

The draft Seventh Edition Cord Blood Standards public comment period has been extended to April 1, 2019. All comments submitted will be reviewed by the Standards Committee to ensure the Standards represent the voice of the Cord Blood community.

FACT recognizes that one of the most important roles in our program is that of the inspector. FACT thanks its inspectors for their time and expertise.  As the number of FACT-accredited programs increases, our needs for inspectors increase and we want our inspectors to know how grateful we are for their service.

As always, there are many educational events throughout the year. Review FACT’s educational calendar and register for an event today.

Articles in this volume include:

  • FACT Common Standards Second Edition Published
  • Draft Seventh Edition Cord Blood Standards Public Comment Period Extended
  • Thank you FACT Inspectors
  • FACT Events at the 2019 TCT Meetings Were a Success
  • FACT International Headquarters New Staff
  • Dr. Helen Heslop Receives Lifetime Achievement Award
  • Cellular Therapy Community Corner

Sincerely,


Dennis A. Gastineau, MD
FACT President