Just the FACTs, 2020 Volume 7
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
ISBT 128 Labeling Standard for Cells Collected for Cellular Therapy Manufacturing: Comments Due October 18th
Thanks to the teamwork of several stakeholders in apheresis cell collection, the field is one step closer toward label standardization. Comments are needed in the most recent draft ISBT 128 label published by ICCBBA by October 18, 2020.
As reported in previous Just the FACTs newsletters, a multi-stakeholder working group led by the Standards Coordinating Body and the Deloitte NextGen Industry Working Group, consisting of industry, registries, accrediting organizations, technology providers, and apheresis and quality subject matter experts, released a draft standard labeling proposal for collected cells.
Public comments following the release of that draft indicated support for ISBT 128 labeling for starting material intended for further manufacturing. After reviewing these comments, ICCBBA has released a draft Standard for Labeling of Collection Products for Cellular Therapy Manufacturing.
This Standard builds on existing ISBT 128 standards, including compatible label dimensions and essential traceability information, but also accommodates sponsor/manufacturer information. As stated by the ICCBBA website, “it is for use only in situations where the sponsor/manufacturer has adopted this standard and has provided the necessary information to populate the sponsor/manufacturer section of the label.” Although the standard was written with apheresis in mind, the label could be used on products collected from other sources and intended for further manufacturing.
Draft Labeling of Collection Products for Cellular Therapy Manufacturing
ASFA Celebrates Apheresis Awareness Day
On September 15, 2020, the American Society for Apheresis (ASFA) celebrated Apheresis Awareness Day. The purpose for this observance is to raise awareness of apheresis medicine, including apheresis practitioners and the donors and patients they save every day using evidence-based practice.
The awareness day included an official hashtag (#ApheresisDay2020), online games including Jeopardy and Apheresis Word Scramble, and a Question of the Day.
We at FACT extend our heartfelt appreciation to apheresis professionals around the world, including physicians, nurses, technicians, scientists, quality managers, and more who work as an important team performing life-saving work every day. We acknowledge the extensive role they play both in providing standard of care therapy and cutting edge research. Apheresis professionals are in high demand because the work they do is so important. Thank you for all that you do!
World Marrow Donor Day: “Join the virtual global donor drive: register online, save a life!”
World Marrow Donor Day 2020 will be on Saturday, September 19, 2020. More than 50 countries around the world will participate to publicly thank donors, and to reach a large audience to recruit more.
On its fifth anniversary, the theme this year will be to “Join the virtual global donor drive: register online, save a life!” Despite millions of registered donors, 40% of patients are not able to find a matched donor. This is especially true for patients with mixed race or from ethnic minorities.
Please consider expressing your gratitude to donors and posting information on how to become a donor on websites, social media, or newsletters. The World Marrow Donor Association (WMDA) provides an online tool for potential donors to find active donor registries in their countries and determine eligibility.
Thank you to all the past, current, and registered donors who selflessly chose to become a donor for someone in need.
World Marrow Donor Day webpage
The Importance of Both Hope and Information when Battling Disease: A FACT Accreditation Coordinator’s Experience
By: Dina Becirovic, MPH, FACT Accreditation Coordinator
I lost a loved one to testicular cancer. At the time of his death two years after diagnosis, my cousin was more alive than most living people. He was an example of someone willing to try different treatments and travel far in the hopes of a cure. He was in his early 40s and living in Bosnia when he was diagnosed early enough that the tumor could be removed. The follow-up scans showed the involvement of the lymph nodes, which were also removed. Subsequent scans showed elevated cancer markers, with additional scans showing nodules in the right lung and kidneys. He remained hopeful that he could still be cured. Holding onto hope, he turned to herbal supplements and cocktails. He would drink fluids that would “boost his immunity.”
With a poor prognosis, his last resort was coming to the United States. The cancer was inoperable at this point as it metastasized close to the walls of the aorta. With the condition that far advanced, his treating physician indicated the stem cell transplant would yield a 10% chance of recovery and cancer remission. He passed away a week after receiving an autologous transplant, two years after his diagnosis. Even in his worst days, he was full of life, unscathed, hoping to see his son again. His experience showed the perseverance, hope, and desperation of someone who wanted to live.
A couple of months ago, I had the opportunity to attend a webinar on the topic of stem cell tourism (Gulera, 2020). This presentation reminded me of what I had already personally seen regarding the extent people are willing to go out of desperation, hope, and a desire to live. My cousin’s experiments with outside remedies did not touch the surface compared to the extreme examples shown during the webinar. Stem cell tourism is often presented to patients as having the ability to treat or cure conditions and diseases such as diabetes, stroke, paralysis, or cerebral palsy (ISSCR, 2014). For example, because of a stem cell treatment in this setting, an individual lost an eye. Perhaps the most gruesome example of stem cell tourism was that of a man with an aggressive growing mass of someone else’s cells in the lower portion of his spine. For treatment and in hopes of finding a cure for quadriplegia post-stroke, that man paid $300,000 for injections (Kolata, 2016).
The International Society for Cell & Gene Therapy (ISCT) describes stem cell tourism as “any unproven or insufficiently proven cell therapies proposed to patients as “treatments or therapies” for a specific financial cost and without recognized biological and medical proofs of safety and efficacy (i.e., without a positive benefit-risk assessment in place)” (ISTC, 2015, p.9). These therapies are often offered to patients in clinics locally and worldwide. Most therapies are not part of the domain of conventional clinical trials, and no regulatory monitoring or information about risks or benefits is available. Furthermore, unproven cell therapies are characterized by the inability to confirm product quality and efficacy due to unclear scientific foundation or experimental procedures or consistency in cell manufacturing, inadequate consent forms, and failure to support clinical use due to incomplete research on action mechanism and biological function (ISCT, 2015).
The International Society for Stem Cell Research (2014) developed a Patient Handbook on Stem Cell Therapies, including stem cell tourism. This resource provides a set of questions one might ask of the clinic or their provider. It also includes the warning signs a patient should look for should they ever find themselves in this situation.
FACT Standards require independent oversight by appropriate agencies, such as an Internal Review Board, ethics boards, and regulatory agencies; the disclosure of risks and benefits; and the disclosure of the cell source and how the cells will be collected, manufactured and administered. Additionally, FACT Standards reinforce training and continued annual competence of stem cell transplant physicians, advanced practice providers, and staff that are providing patient care in the stem cell transplant field. These requirements would mitigate the risks of stem cell tourism of clinics that voluntarily comply with them.
For a list of patient-related resources on Stem Cell Tourism and similar topics, visit the FACT website. Whatever you do for yourself or a loved one, be informed.
References
Gulera, I. (2020). Stem Cell Tourism [Webinar]. AABB Spanish Subsection.
Kolata, G. (2016, June 23). A Cautionary Tale of ‘Stem Cell Tourism’. https://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stem-cell-tourism.html.
International Society for Cellular Therapy. (2015). ISCT Presidential Task Force on the Use of Unproven Cellular Therapies: Reference Guide. https://isctglobal.org/page/PTF2015 .
Mummery, C. L., Stolpe, A. van de, Roelen, B. A. J., & Clevers, H. (2014). Chapter 11. In Stem cells: scientific facts and fiction. Elsevier/AP, Academic Press is an imprint of Elsevier. https://doi.org/https://doi.org/10.1016/B978-0-12-411551-4.00011-8
Calling All Cord Blood Banking Professionals!
There is still time to register for the FACT Inspection & Accreditation Virtual Workshop scheduled for Monday, September 21, 2020, from 8:00 am to 3:00 pm CT. Register for the workshop today!
Workshop presenters have a special message for all cord blood banking professionals below.
We hope to see you at FACT’s very first virtual workshop on September 21st!
Calling All Apheresis Professionals!
There is still time to register for the FACT Inspection & Accreditation Virtual Workshop scheduled for Monday, September 21, 2020, from 8:00 am to 3:00 pm CT. Register for the workshop today!
Workshop presenters have a special message for all apheresis professionals below.
We hope to see you at FACT’s very first virtual workshop on September 21st!
Upcoming Quality Management Series Module 10: Validation
Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT
Presenters will discuss the following:
- Range to validate (where to start and when to stop), variables and extreme scenarios
- Process validations (to include Bone Marrow process)
- Verification: when is it needed
Software Validation
Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT
Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:
- Critical electronic systems under the control of the organization (facility)
- Spreadsheets
- Vendor and organization responsibilities
Program Perspective on Validation
TBA
Register for the entire series to receive a 15% discount!
Module 10 includes all of the upcoming webinars and the recording of the first webinar:
Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT
Dr. Prokopishyn discussed the differences among Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.
