President’s Letter
Last year, FACT celebrated its 20th anniversary and spent the year reflecting on its history and celebrating its accomplishments. This year, the FACT Board of Directors participated in a strategic planning retreat to envision future successes and what FACT needs to do to achieve them. The two-day retreat was filled with questions, laughter, debate, and discussion. All of this culminated into defining objectives and strategic goals for the years 2017 through 2020 that we are excited and eager to pursue.
Though FACT is poised to be a player in many exciting developments in the field of cellular therapy, we have not lost our focus on our mission: to improve the quality of cellular therapy through standards, accreditation, and education for the benefit of patients. Indeed, every new initiative we begin will ultimately become a routine part of fulfilling our mission through our core services. Many of our defining objectives and strategic goals relate to organizational infrastructure to maintain our strength and flexibility to address emerging issues as they come.
Our ability to respond to the needs of the field, using new and improved resources to do so, directly impacts the care our patients receive. By doing this, we also strengthen our relationships with like-minded organizations and develop new collaborations with colleagues in different capacities. This allows us to push the envelope on our ability to evaluate and encourage quality practices with synergistic efficiency. Our clinical outcomes improvement and data management initiatives, both made possible by the efforts of the Center for International Blood & Marrow Transplant Research (CIBMTR), harness the power of data to improve patient survival and research. Our close collaboration with our peers in the Latin America Blood and Marrow Transplantation Group (LABMT) is improving the quality of transplantation in new regions of the world. Our new accreditation program for immune effector cellular (IEC) therapy, largely created in response to requests from commercial biological product manufacturers, has been mutually beneficial and educational and, hopefully, will improve access to new and lifesaving cellular therapies. Our work with the Cardiovascular Cell Therapy Research Network (CCTRN) is leveraging our experience and the CCTRN’s cardiovascular expertise to evaluate how FACT can help even more patients in more specialties.
Sincerely,
Dennis Gastineau, MD
FACT Announces 2017-2020 Strategic Plan
FACT’s strategic plan anticipates and addresses opportunities and challenges for the next several years. The strategic plan also identifies several “Defining Objectives.” Although all the goals in a strategic plan are important and meant to be accomplished, several are designated as highest priority. Accomplishing these priority goals defines FACT’s success over the next period of time.
The three defining objectives and additional goals for the 2017-2020 period are:
Defining Objective #1: INSPECTIONS
The highest possible level of excellence and consistency in inspections of programs and facilities.
Defining Objective #2: IMMUNE EFFECTOR CELL THERAPY
Rapid mobilization of an accreditation service for immune effector cellular therapy programs.
Defining Objective #3: FINANCES
Sufficient financial resources to sustain operations and build reserves for the development of mission-directed products and services and for surviving an economic downturn.
Strategic Objective #4: REGENERATIVE MEDICINE
Continued promotion of the FACT Common Standards for Cellular Therapies, and readiness to introduce disease- or medical specialty-specific standards when appropriate.
Strategic Objective #5: CLINICAL OUTCOMES IMPROVEMENT
Cellular therapy programs that know how to prevent, investigate and correct deficiencies in clinical outcomes.
Strategic Objective #6: STANDARDS
Clear and user-friendly FACT standards and effective transition between editions of standards.
Strategic Objective #7: ACCREDITATION
Consistency in the awarding of FACT accreditation.
Strategic Objective #8: CORD BLOOD BANKING
Recognition of FACT as the premier accreditation for both public and private cord blood banks.
Strategic Objective #9: EDUCATION
Recognition that education is as important as standards and accreditation within FACT’s mission to promote quality in cellular therapy.
Strategic Objective #10: ORGANIZATIONAL EFFECTIVENESS
Organizational health is one of FACT’s greatest strengths.
Resources Continuously Added to FACT Website
Topics include clinical outcomes, immune effector cellular therapy, patients and families, and more
To support FACT-accredited organizations and the FACT mission to improve cellular therapy, resources are continuously added to the FACT website. This article highlights just a few of the informational webpages that provide links to journal articles, instructions, examples, and more.
FACT supports blood and marrow transplant (BMT) programs’ efforts to evaluate one-year survival data to improve patient outcomes, advance the field, and maintain payer and public confidence. FACT requires programs to submit a corrective action plan when one-year survival does not at least meet expected outcomes as demonstrated in comparative data. Several resources are available to assist programs with identifying trends in cause of death, the root causes, and corrective and preventive actions. This page includes links to comparative data sources (especially helpful to autologous-only and non-U.S. programs), educational resources, and example corrective action plans. The page also lists the guidelines for corrective action plans for quick reference.
The main objective of FACT’s Immune Effector Cell Standards is to promote quality practice in immune effector cellular therapy. FACT is committed to supporting efforts to make quality immune effector cellular therapy accessible to patients much like it did for bone marrow transplant and cord blood banking. Several resources are available to assist with understanding immune effector cells and implementing FACT Standards. Resources include FACT Standards for Immune Effector Cells, educational on-demand webinars, frequently asked questions, and journal articles. Examples of guidelines and procedures used by organizations for managing immune effector cell programs and patients will soon be available.
Education and assistance for cellular therapy patients and their families are key to promoting desirable clinical outcomes. Direct links to a variety of organizations and informational sources are listed for several topics, including donor registries, information and support, cord blood banking and donation, and clinical trials and access to cell therapies.
Although quality management is relatively new to cellular therapy programs and cord blood banks, the principles of quality assurance and quality control have long been incorporated. For the FACT accreditation process, the real turning point for emphasis on quality management activities was with the release of the third editions of the Cellular Therapy Standards and Cord Blood Standards, which included greatly expanded Quality Management sections. Since that time, FACT has developed and introduced quality-based educational materials to assist your organization with developing and enhancing your Quality Management Program.
Many New Developments in FACT Standards Development Activities
The FACT Standards Committees have been busy reviewing feedback, discussing new developments in cellular therapy, and editing drafts for several different sets of Standards. Updates for each set of Standards are provided below. As progress continues, important updates will be announced via weekly emails and future Just the FACTs newsletters.
FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, 7th Edition
FACT and JACIE are finalizing the 7th edition Hematopoietic Cellular Therapy Standards, which is scheduled for publication in March 2018. These Standards apply to all phases of collection, processing, storage, and administration of hematopoietic cellular therapy products. This includes hematopoietic progenitor cells (HPCs), mononuclear cells (MNCs), and immune effector cells (IECs) derived from marrow, apheresis, or cord blood, and administered by a blood and marrow transplant (BMT) team.
After March 1, 2018, only Compliance Applications under the 7th edition will be accepted and only inspections under this new edition will be conducted after the effective date of May 30, 2018. Programs currently pursuing renewal or initial accreditation under the 6th edition must remain mindful of these dates and ensure timely submission of pre-inspection materials and completion of the inspection.
The FACT Accreditation Services department is contacting accredited and applicant programs who will be beginning the accreditation process at the time of publication to discuss the transition. We understand the effort required to complete the accreditation process and will be ready to assist programs with timely submission of the Compliance Application in accordance with the new edition.
The FACT-JACIE Standards Steering Committee meets in Orlando to review the 7th edition draft Standards.
FACT Standards for Immune Effector Cells, 1st Edition
The FACT Standards for Immune Effector Cells apply to immune effector cellular (IEC) therapy programs that are independent of a transplant program. Standards specific to IEC therapy are also contained within the FACT-JACIE Hematopoietic Cellular Therapy Standards for programs that perform both transplant and IEC therapy. To ensure both sets of Standards include the most up-to-date requirements in this new field, requirements will be published in an interim version of the 1st edition Immune Effector Cell Standards. Once effective, the updated version of the Standards will be the basis of inspections going forward.
A list of the small number of changes to the Immune Effector Cell Standards will be provided at the same time the 7th edition Hematopoietic Cellular Therapy Standards are published in March 2018.
FACT Common Standards for Cellular Therapies, 2nd Edition
The FACT Common Standards for Cellular Therapies is currently undergoing revision. The Common Standards Committee consists of members representing a wide variety of specialties to ensure the Common Standards continue to represent the basic fundamentals applicable to any type of cellular therapy. This includes hematopoietic progenitor cell (HPC) transplantation, IEC therapy, cardiovascular medicine, cord blood banking, cell collection, and cell processing with minimal and more-than-minimal manipulation. A draft for public review and comment is expected in April 2018.
NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, 7th Edition
The Steering Committee for the 7th edition of NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration will initiate the development process at the 2018 BMT Tandem Meetings in February.
FACT and WMDA-NetCord invite you to complete a short survey focused on general concepts of interest regarding the Standards. The results of this survey will be reported to the Standards Steering Committee for review and consideration as it begins to draft the next edition. Your input helps maintain the clarity, usefulness, and relevance of the Standards. Responses will be accepted through December 29, 2017. The 7th edition is scheduled for publication in October 2019.
The Role of Medical Records During On-Site Clinical Program Inspections
Last year, FACT and CIBMTR announced their collaborative data assessment program, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited Clinical Programs. Not only has this program intensified support and improvement of Clinical Programs’ data management and reporting processes, it saves time for programs audited by CIBMTR by reducing the need to make Transplant Essential Data (TED) forms and source documentation available to FACT inspectors during the on-site inspection.
Despite the reduction in records to produce for the data audit, there is still a critical need for access to medical records during on-site inspections. Compliance with many standards can be verified through medical records including:
- Donor and recipient informed consent;
- Donor eligibility evaluation and determination;
- Compliance with established policies, procedures, and guidelines;
- Verification of preparative regimens and recipient identity against protocols;
- Detection, evaluation, reporting, correction, and prevention of adverse events and other occurrences; and
- Verification of corrective action plan implementation.
Pre-selected and organized medical records facilitate inspector review. Pre-select records that represent a variety of situations applicable to your program, including:
- Allogeneic, autologous, and haploidentical transplants;
- Transplants using cells derived from peripheral blood, bone marrow, and cord blood;
- Cellular therapy using novel products such as immune effector cells (IECs);
- Adult and pediatric patients; and
- Adverse events, positive microbial cultures, and ineligible donors. (Yes! Showing inspectors medical records that represent less than ideal, but inevitable, circumstances will improve the results of your inspection by allowing inspectors to verify compliance with all standards.)
(A note about electronic medical records (EMR): Because it takes time to navigate electronic systems, it will also take time for the inspector to become familiar with your EMR. Create printed shadow charts and/or plan to navigate the system for your inspector. It is a good idea to communicate with your inspector in advance regarding his/her preferences.)
With the time saved by eliminating the need to produce accessible copies of TED forms, spend time selecting medical records from a variety of situations, evaluate your processes and make improvements where necessary. Use this opportunity to show your inspector how you continuously improve your program. That is, after all, the real purpose of FACT accreditation.
Inspection of Fixed or Non-Fixed Cord Blood Collection Sites? That is the Question for FACT.
Cord blood banks accept the noble challenge of collecting what many still unfortunately consider medical waste – placental and umbilical cord blood – and transforming it into a lifesaving therapy. In many cases, this is accomplished by establishing formal relationships with specific hospitals and other birthing units, with a written agreement between the collection site and the bank for the collection of cord blood units. The agreement describes the interaction between the collection site and the bank for all aspects of the collection process including, at a minimum, personnel training, record keeping, collection, storage, and transportation or shipping of a cord blood unit.
There are also non-fixed collection sites, where the collection of cord blood is initiated by the infant donor’s mother or family. For these sites, banks must document that a health care professional has agreed to perform the collection in accordance with the cord blood bank’s collection procedures and must provide training that covers each aspect of the collection process. Cord blood collection at these sites are typically infrequent.
The NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration make very few distinctions between fixed and non-fixed collection sites, because both types have a direct impact on the quality of the cord blood unit ultimately given to a patient. Therefore, because they perform a critical step of the cord blood banking process, facilities that collect cord blood units for an applicant cord blood bank are inspected during the accreditation process.
There are several models used by cord blood banks to collect placental and umbilical cord blood, and FACT and WMDA-NetCord acknowledge the need for banks to institute models that work best for them. Banks submit information about all collection sites to FACT; with that information, FACT determines what collection sites will be inspected as part of the accreditation process. Collection sites are selected depending on a number of variables to allow verification of compliance of all processes used by the bank. Examples of variables include:
- Distance from the bank,
- Mode of transport from the collection site to the bank (e.g., private courier, donor family, commercial shipper),
- Travel time between the collection site and bank,
- Temporary storage location between the collection site and bank,
- Average number of units collected per year,
- Method of collection (in utero, ex utero, or both),
- Type of unit (e.g., unrelated allogeneic, directed allogeneic), and
- Collecting professional (e.g., bank employee, obstetrician, collection site employee).
Sometimes, cord blood banks consider a relationship with a collection site to be non-fixed, but FACT still must inspect those sites because of their responsibilities. For example, collection sites that collect a large number of cord blood units a year, store collection kits, obtain informed consent, or perform other responsibilities may be inspected. Inspectors have identified areas for improvement at such collection sites, and we believe that the processes banks implement to address these issues will result in higher quality units. Many of the deficiencies are easily resolved by the bank, and place little burden on the collection sites themselves; sometimes they make the process better for the sites. For example, a high microbial contamination rate may be attributed to the collection process. The bank can decrease the contamination rate by providing clearer Standard Operating Procedures (SOPs) and training regarding preparation of the needle site and handling of equipment.
We are a FACT-Accredited Transplant Program Providing Immune Effector Cellular Therapy.
What Do We Need to do to Meet Accreditation Requirements?
This question is frequently asked and for good reason. FACT-accredited blood and marrow transplant (BMT) programs that provide immune effector cellular (IEC) therapy must not only comply with the standards specific to IECs, but they must also apply all FACT Standards to their IEC programs as applicable. If just beginning IEC therapy, programs must be in compliance with the Standards as part of starting the new activity.
First, get to know yourself.
Ask the following questions:
- How many different IEC products are administered by our program? Are they industry-sponsored trials or investigator-initiated trials? Do we plan to administer licensed products?
- Who is responsible for infusing the IECs and treating the patient, and where is this physically performed (e.g., Do BMT attending physicians administer the products? Are the products administered on the BMT unit or elsewhere?).
- Who collects and manufactures the products? Is it collected in-house? Is it manufactured at an external company? Does the processing facility ever have control of the product?
- How is chain of custody established? Is an intermediary facility (e.g., hospital pharmacy, blood bank) ever involved?
- Are there any protocols established that include addressing issues related to IECs, including toxicities?
- Are physicians and staff trained in administering IECs, recognizing expected complications, and addressing adverse events?
- What data is collected, how is it managed, and how is it analyzed? What happens when an issue is detected?
- How is the IEC program integrated into the quality management (QM) program?
- Who is leading the IEC program? Is it the BMT Program Director or someone from a different service (such as leukemia)?
Second, talk to your Accreditation Coordinator at the FACT Office.
The value of the FACT Accreditation Coordinator cannot be overstated. With information gathered from the questions above, you can discuss your program’s model with the coordinator and determine next steps. Potential next steps may be:
- If preparing for a renewal inspection, submit all required documentation for immune effector cellular therapy in the Compliance Application and prepare for the inspection.
- If in the middle of the accreditation cycle, discuss your options. To receive an accreditation certificate for immune effector cellular therapy you must be inspected. You may choose to request an add-on inspection mid-cycle, or you may choose to wait until the renewal inspection.
- If completing the annual reporting process, report that you provide IEC therapy and attest whether you have reviewed the new standards and comply with them. Again, this will not result in IEC accreditation being listed on the FACT website as discussed above.
Third, perform a gap analysis of the Standards to determine compliance and correct any deficiencies.
Determine any gaps in compliance with the Standards. What processes need to be established, updated, or documented? Management of IEC products and their donors and recipients should become a routine part of the program; they will not be new to the program forever. There is no need to reinvent the wheel. In fact, establishing separate processes solely for IECs could put the program at risk for nonconformities and errors. Determine where the IEC program may need to be incorporated into existing processes, such as:
- Immediate access to drugs to treat cytokine release syndrome (note that this has been reported for haploidentical transplants and is not specific to IEC therapy),
- Nurse training (additional training modules may be required to train nurses as new therapies are provided), and
- Audits and outcome analysis (incorporate newly required audits and analyses into the existing schedule and perform them according to established procedures; remember that the analysis required at 30 days is required of all cellular therapies, not just IECs).
To be accredited for IEC therapy, programs must have mechanisms to comply with all standards related to toxicities even if they currently do not administer notably toxic IECs such as chimeric antigen receptor (CAR) T cells. For example, if a program only administers mesenchymal stromal cells (MSCs) for graft versus host disease (GVHD), which is not known to be as toxic, it still must provide staff training and develop policies for addressing known toxicities of a variety of IECs. This is to ensure transparency, credibility, and understanding of what FACT accreditation for IECs means. Due to the rapid growth in this area of cellular therapy, it is likely that programs will increasingly be adding new types of IECs to their repertoire. With this approach, not only will FACT accreditation remain clear and meaningful, accredited programs will be prepared to continue their ability to offer new therapies to patients.
Establishing Efficiencies Between IND Requirements and FACT Standards
Many FACT-accredited cellular therapy programs participate in clinical trials, and awareness of such activities has become more pronounced with the advent of FACT’s new voluntary accreditation for immune effector cellular (IEC) therapy. Most IEC products are administered under Investigational New Drug, or IND, requirements.
There are some FACT requirements that are not typically required of INDs but could greatly enhance research, such as a quality management program, accessible procedures, and training. Likewise, some typical IND requirements could be used to also satisfy FACT requirements, and documentation created to comply with IND requirements can be used.
Outcomes
FACT requires outcome analysis, which is also performed in accordance with IND requirements. The program does not need to gather and report its own independent data if this is already performed by the investigator and shared with the program. This could be demonstrated through minutes from a quality meeting where outcomes were reviewed, or within signed outcome analysis reports. The key is that outcome information is reported back to the accredited center’s Quality Management (QM) program in some fashion to allow assessment of program performance (such as personnel training and competency or needed procedural improvements).
Product efficacy based on patient outcome may be difficult to document for novel cellular therapy products, and that assessment will differ for each product type. Predefined outcome criteria for investigational cellular therapy products (e.g., CAR T-cells, vaccines) may be found in the clinical research protocol and may include clinical outcomes or only safety endpoints, depending on the trial phase. Data from each investigational product does not need to be aggregated in total; for example, IECs vary widely in cell type, manipulation, protocol, and indication. However, data regarding similar products may shed important light on process improvements within the control and discretion of the program (protocols must be strictly followed per IND requirements).
Reporting of outcome data also advances the field. FACT Standards recommend that Clinical Programs collect each of the data elements contained in the applicable CIBMTR Cellular Therapy forms or EBMT forms. Use of the actual form and submission to CIBMTR or EBMT is not required unless dictated by applicable laws and regulations. FACT strongly recommends the publication of data and strongly encourages the submission of data to the CIBMTR. In the event that the Clinical Program does not submit data to these registries, it should provide reasonable explanations for not doing so. Examples of the forms currently utilized by the CIBMTR may be found on the organization’s website at http://www.cibmtr.org.
Audits
Similar to outcome analysis, audits are typically performed as directed by INDs and the results of those audits can satisfy FACT Standards if they are forwarded to the QM Program for review. If an IND does not require an audit, then an audit as required by the Standards must take place.
Policies and Procedures
Many programs utilize IND protocols to satisfy FACT requirements for SOPs. At a minimum, programs should have a local, high-level SOP that describes the big picture of the activities to perform. Actual protocols could be referenced and made available to staff, or the detailed procedural steps could be outlined in job-specific SOPs. Some manufacturers have very specific SOPs and provide them to programs, and, in these cases, there is no need to copy the SOP over to the program’s format. However, protocols are not a no-fail way of meeting the intent of the standard. Programs should ensure that the protocols include specific details for staff performance without being burdensomely long, that they are accessible to staff, and that training on the protocols has been performed.
FDA Publishes Final Guidance for Reporting HCT/P Deviations
The Food and Drug Administration (FDA) announced the availability of a final document entitled, “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Guidance for Industry.”
The guidance document provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations.
Far-Flung FACTs: Interviews with FACT-NetCord Accredited Cord Blood Banks Around the World
FACT interviewed personnel at cord blood banks that are FACT-NetCord accredited in geographically unique locations and published corresponding articles in the Telegraft, the bi-monthly online newsletter of the International Society for Cellular Therapy (ISCT). The articles describe the unique challenges the banks face in their geographic regions, and the benefits they receive from FACT-NetCord accreditation. Interviews with three cord blood banks have been published:
Juliette Liatsou, MSc, Quality Manager of CYCORD Cord Blood Bank, in Nicosia, Cyprus
Meral Beksac, MD, PhD, Director of Ankara University Cord Blood Bank, in Turkey
The Telegraft provides those in or interested in the cell therapy community with current information on new developments, items of interest, regulatory updates, summaries of work being done in both academic and industry labs around the world, and much more. Special issues are also published as required to cover developments of particular importance or interest to the ISCT membership.
ASBMT Completes Busy Month of Policy Initiatives
Corporate Council Meeting
The American Society for Blood and Marrow Transplantation (ASBMT) leadership and past presidents met in late September with industry and BMT thought leaders at the ASBMT Corporate Council meeting. Among the Council’s many objectives is to establish meaningful dialogue between industry leaders, healthcare providers, and the ASBMT’s leaders. Headed by Armand Keating, MD, the Council aims to share information, advice and assistance to address specific BMT issues.
During this year’s meeting, discussions focused on the challenges of supportive care after stem cell transplant, the role of immune cell-based therapies, engineered T Cell therapy, and ASBMT’s efforts to improve access and referral for blood and marrow transplantation (BMT). An overview of health policy issues was also presented by ASBMT Director of Health Policy and Strategic Relations, Stephanie Farnia.
Visit the ASBMT website for more details about the Corporate Council.
Comment Submissions
ASBMT submitted several letters addressing important policy considerations to the Centers for Medicare & Medicaid Services (CMS). The letters addressed topics such as the unintended consequences of proposed changes to the outpatient prospective payment system; concerns with proposed changes to bone marrow aspiration, apheresis, and chemotherapy codes within the physician fee schedule; and concerns anticipated during the first year of providing CAR-T therapies to the Medicare population.
Review the letters on the ASBMT website.
Legislative Day
ASBMT hosted its first Legislative Day in Washington, D.C., on Thursday, Sept. 7, in partnership with the NMDP. The goal for the day was to educate Congressional representatives on issues that affect the field of hematopoietic cell transplantation – Medicare reimbursement, physician payment, and research funding.
Additional details about the Legislative Day are available on the ASBMT website.
Michele Sugrue Outlines Her Recipe for Successfully Performing FACT Inspections
In 1997, the first book in the Harry Potter series was published in the United Kingdom. It was at that time, shortly after preparing for our program’s first “FAHCT” inspection, that I considered serving as an inspector. I felt that being able to visit other programs and observe operations firsthand would not only better expose me to the cellular therapy community and provide an educational experience, but also allow me to contribute to process improvement initiatives at the BMT program at UF Health. My first assignment was in 1998. While that seems like a lifetime ago, I continue to appreciate the opportunity to represent FACT as much today as I did back in the “20th century”. Since then, my goal is to perform at least two inspections each year, as either a Processing or Apheresis Collection Facility Inspector. Being qualified to perform inspections in both areas provides me an enhanced perspective of the cellular therapy product life cycle – collection, processing, storage, and administration. In the following paragraphs, I share some insights, approaches and “tricks of the trade” that I have learned along the way.
“Before anything else, preparation is the key to success.” Alexander Graham Bell
The most important preparation tip that I share with inspector trainees is to start the “desk” inspection early in order to allow ample time for thorough review. By planning sufficient time for review, well prior to the date of inspection, an inspector can request further information and clarifications. This ultimately allows for a more efficient inspection. I developed a personal SOP for inspection preparation titled, Preparing to Perform a FACT Inspection, which has undergone many revisions, been validated, and approved by Quality Management and continues to serve as the basis for my approach to inspections.
First, I confirm scheduling and travel arrangements with FACT office staff and the inspection team leader (I provide my cell phone number in case of emergencies). My next step is to review the application in order to understand the services provided, volume of activities, and organizational structure of the applicant program. I print the assigned inspector checklist, which contains applicant responses, and begin a comprehensive review of all documents provided in the application. Often several sections of the checklist can be completed by document review, such as label content requirements and key staff credentialing, well before departing for the applicant site. As I proceed through the checklist and review the QM Plan, SOPs and other documents; stickers with notations are placed next to Standards requiring further clarification or observation on site. In addition, I develop a written list of questions to have in hand upon arrival on the day of inspection. Preparation is not complete until the entire checklist and all documents have been reviewed. Yes indeed, I am “old-school,” and assemble a three-ring binder containing printed materials to have on hand during the inspection. It resembles a mini version of the original four-inch binders that were sent to inspectors before the accreditation portal was launched. My binder is complete with section dividers, is only one or two inches, and contains only area-specific printed materials. Once at the inspection site, I again work through the checklist and systematically remove the stickers and cross out items on my list. Ultimately, at the end of the day, what remains is a new list of potential citations and/or variances along with commendable practices.
“The best-laid plans of mice and men / Go oft awry.” Robert Burns
As inspectors, we diligently work to prepare for an efficient and well-structured inspection day. Occasionally, schedules fall apart. As such, we must exhibit flexibility and maintain composure and professionalism. Developing a detailed agenda with the inspection team and site coordinator can often avoid poor time management, yet unforeseen factors can impact the best of intentions. Amazingly, more often than not, I have arrived at a facility where no apheresis collections, product processing, or administration procedures have been scheduled for observation. That is when I quickly switch to “mock” procedure mode and work to allow sufficient time to perform a thorough observation. Being prepared prior to arrival on site with the skillset to examine both actual and “mock’” procedures puts the facility site at ease and allows the inspector to perform a complete review.
“Without continual growth and progress, such words as improvement, achievement, and success have no meaning.” Benjamin Franklin
After hours of preparation and a long day, inspectors will conduct an exit interview with the applicant program staff and institution leadership. I have come to approach these meetings in such a manner to avoid the unexpected and to offer positive feedback. I always make it a point to have discussed all significant potential citations, variances, and concerns with area managers and directors, if available, prior to the exit session. My standard exit session script begins by thanking the staff (by name) for their patience and hard work, no matter how well or poorly the day unfolded. I then reiterate that I have inspected the facility with the “X” Edition FACT-JACIE Standards and that the FACT Accreditation Coordinator will present my report to the FACT Accreditation Committee for review. I share my observations and potential citations and variances to the group with reference to specific examples. I consider it equally important to also describe commendable practices such as process improvement efforts, exemplary SOPs and worksheets, or praiseworthy practices or achievements. As inspectors, we cannot diminish the importance of the exit session, as it can often be what is most remembered of the inspection day’s activities by those in attendance.
It has been an honor and privilege for me to serve as a FACT Inspector. While it requires time and effort outside of my office and personal life, I am convinced that both my home BMT program and I greatly benefit from the experience. I encourage those interested to join the FACT inspectorate.
Congratulations to our New Inspectors!
The following individuals completed their first active inspection in the time period from January 2017 through September 2017. Congratulations and thank you for volunteering your time and expertise to advance cellular therapy! Organizations with personnel who also serve as FACT inspectors typically perform better during on-site inspections than their counterparts without an inspector. If you are interested in serving as an inspector, submit an online application!
Ibrahim Ahmed, MD
Cellular Therapy Clinical Program and Marrow Collection
The Children’s Mercy Hospital Blood and Marrow Transplant Program
Monzr Al Malki, MD
Cellular Therapy Clinical Program and Marrow Collection
City of Hope Hematopoietic Cell Transplantation Program
Nicole Aqui, MD
Cellular Therapy Apheresis Collection
Blood & Marrow Collection and Processing Program of the University of Pennsylvania Medical Center
Sherman Bakabak, BSMT(ASCP)
Cellular Therapy Processing: Minimal Manipulation of HPC
UCSF Benioff Children’s Hospital Pediatric Cellular Therapy Laboratory
Gloria Barrueco, BS, AMT
Cellular Therapy Processing: Minimal Manipulation of HPC
Blood and Marrow Transplant Center at Florida Hospital
Wendy Beron, MSN, RN, OCN
Cellular Therapy Apheresis Collection
NYU Langone Health Hematopoietic Progenitor Cell Transplant Program
Charlene Briedenbaugh, BS, HP, MLT(ASCP)
Cellular Therapy Apheresis Collection
Allegheny Health Network, Cancer Institute, West Penn Hospital
Yeong Choi, PhD
Cellular Therapy Processing: Minimal Manipulation of HPC
cGMP: Therapeutic Cell Production Facility
Omotayo Fasan, MBSS, MRCP
Cellular Therapy Apheresis Collection
The Center for Bone Marrow Transplantation at Geisinger Medical Center
Barbara Gagliardi, D.Sc
Cord Blood Banking
Milano Cord Blood Bank
Gerhard Hildebrandt, MD
Cellular Therapy Clinical Program and Marrow Collection
University of Kentucky Blood and Marrow Transplant Program
Jogesh Jethava, MD, FACP, MRCP (UK), FRCPath (UK)
Cellular Therapy Clinical Program and Marrow Collection
The Blood & Marrow Transplantation Program of the Holden Comprehensive Cancer Center at the University of Iowa
Sarita Joshi, MBBS, MD
Cellular Therapy Clinical Program and Marrow Collection
Cleveland clinic foundation, Department of Blood Banking and Transfusion Medicine
Deepika KC, MS, BS(ASCP)
Cellular Therapy Processing: Minimal Manipulation of HPC
Mayo Clinic Arizona
Sajad Khazal, MD
Cellular Therapy Clinical Program and Marrow Collection
The University of Texas MD Anderson Cancer Center Stem Cell Transplantation and Cellular Therapy Program
Wanda Koetz, RN, HP(ASCP)
Cellular Therapy Apheresis Collection
Memorial Blood Centers
Kathryn Suet Wa Leung, MD
Cellular Therapy Clinical Program and Marrow Collection
Children’s Healthcare of Atlanta Blood and Marrow Transplantation Program
Elina Linetsky, PhD
Cellular Therapy Processing: Minimal Manipulation of HPC
cGMP Cell Processing Facility Diabetes Research Institute University of Miami Miller School of Medicine
Parinda Mehta, MD
Cellular Therapy Clinical Program HPC
Cincinnati Children’s Hospital Medical Center, Cancer and Blood Diseases Institute, Bone Marrow Transplantation and Immune Deficiency Program
Andrea Meyer
Cord Blood Processing
José Carreras Cord Blood Bank Düsseldorf
Huy Pham, MD, MPH
Cellular Therapy Apheresis Collection
The University of Alabama Adult and Pediatric Bone Marrow Transplantation and Cell Therapy Program
Sai Ravi Pingali, MD
Cellular Therapy Clinical Program and Marrow Collection
Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
Opal Preston, RN, BSN, MT (HEW), QIA
Cellular Therapy Apheresis Collection
University of Virginia Health System
Aravind Ramakrishnan, MD
Cellular Therapy Clinical Program and Marrow Collection
Texas Transplant Institute at Methodist Hospital, Methodist Children’s Hospital in San Antonio and South Austin Medical Center in Austin
Laleh Ramezani, BS, MLT
Cellular Therapy Processing: Minimal Manipulation of HPC
USC Blood and Marrow Transplant Program
David Shyr, MD
Cellular Therapy Clinical Program and Marrow Collection
The University of Utah Blood and Marrow Transplant Program
Roni Tamari, MD
Cellular Therapy Clinical Program and Marrow Collection
Memorial Sloan-Kettering Cancer Center – Blood and Marrow Transplant Program
Priti Tewari, MD
Cellular Therapy Clinical Program and Marrow Collection
Baylor College of Medicine, Stem Cell Transplant Program, Texas Children’s Hospital and Houston Methodist Hospital
Ravi Vij, MD, MBA
Cellular Therapy Clinical Program and Marrow Collection
Stem Cell Transplant Program at Barnes-Jewish Hospital and St. Louis Children’s Hospital at Washington University School of Medicine
Upcoming Educational Events
FACT Immune Effector Cellular Therapy Inspection and Accreditation Workshop at SITC Annual Meeting
Thursday, November 9, 2017
National Harbor, MD
This training workshop is designed to educate participants on two key perspectives: building quality into their immune effector cell programs and performing peer-based inspections. FACT’s mission is to improve the quality of cellular therapy programs and depends on volunteer experts to visit programs and assess their compliance with the Standards. This peer-review approach keeps FACT accreditation credible, relevant, and useful. Attendees will learn about the mission of FACT, principles of FACT Standards, the accreditation process, and basic inspection techniques.
Registration is free for current inspectors and approved inspector trainees. Physicians wishing to train to become an inspector for the FACT Immune Effector Cell Accreditation Program must meet prerequisite education and experience requirements, submit a satisfactory inspector application, attend an in-person training workshop, view online videos, and complete a test on the requirements. To apply to become an inspector, submit an online application.
View meeting details and register online
WMDA-NetCord Webinar: Manual and Automated Methods for Thawing of Cord Blood
Wednesday, November 29, 2017
Webinar
This WMDA-NetCord webinar is November 29, 2017, at 11:00 ET. Cellular therapy departments must thaw cord blood units, and they often use very different processes from the procedures outlined by the cord blood bank providing the unit. These SOPs are sent by the cord blood bank and are not always adapted to the disposals and reagents used by the department who then thaw the units. Diane Fournier, PhD, of Héma-Québec, and Roger Horton, PhD, of The Anthony Nolan Cord Blood Bank, will discuss manual and automatic thawing methods used by different departments for thawing of these units, and what can be done to improve recovery of the cells. Also, a multi-center study for harmonization of post thaw analysis of CD34 and CD45 cells will be presented.
View meeting details and register online
FACT Immune Effector Cellular Therapy Inspection and Accreditation Workshop at ASH Annual Meeting
Friday, December 8, 2017
Atlanta, GA
This training workshop is designed to educate participants on two key perspectives: building quality into their immune effector cell programs and performing peer-based inspections. FACT’s mission is to improve the quality of cellular therapy programs and depends on volunteer experts to visit programs and assess their compliance with the Standards. This peer-review approach keeps FACT accreditation credible, relevant, and useful. Attendees will learn about the mission of FACT, principles of FACT Standards, the accreditation process, and basic inspection techniques.
Registration is free for current inspectors and approved inspector trainees. Physicians wishing to train to become an inspector for the FACT Immune Effector Cell Accreditation Program must meet prerequisite education and experience requirements, submit a satisfactory inspector application, attend an in-person training workshop, view online videos, and complete a test on the requirements. To apply to become an inspector, submit an online application.
View meeting details and register online
WMDA-NetCord Webinar: Cord Blood Outcome Data: How to Get it and How to Use it
Wednesday, December 13, 2017
Webinar
This webinar is December 13, 2017, at 10:00 ET. It is often difficult for cord blood banks to obtain outcome data following administration. Gesine Koegler, PhD, of the José Carreras Cord Blood Bank in Düsseldorf, and Andrea Darrow, Quality Manager at Cryo-Cell International, will discuss how to get and how to use cord blood outcome data. What have banks done that work well? And, once the information is received, how can it be used?
View meeting details and register online
QM Series 8: Staff Involvement in Document Control: Where do YOU fit in?
Wednesday, January 10, 2018
Webinar
This webinar is January 10, 2018, at 11:00 am ET. Mary Ann Kelley, DFCI, Associate Director of Quality Assurance CMCF at Dana Farber Cancer Institute / Cell Manipulation Core Facility, will discuss how staff is critical in the document control process, including developing, revising, reviewing, training, and accessing records. It will include information about protocols, and how to give staff access if programs rely on protocols instead of programmatic SOPs. This is the second webinar in the QM Series, Module 8.
View meeting details and register online
Applying the FACT Cord Blood Standards in Private Banking
Wednesday, January 17, 2018
Webinar
This webinar is January 17, 2018, at 9:00 AM ET. Elisabeth Semple, PhD, Cord Blood Bank Director at Cells for Life Cord Blood Institute Inc., Arvin Faundo, MD, Cord Blood Bank Director at Cordlife Group Limited, and Alexander Platz, MD, Cord Blood Bank Director at DKMS Cord Blood Bank, will discuss how family cord blood banks can comply with the NetCord-FACT 6th Edition Cord Blood Standards, methods to overcome challenges, and the benefits to achieving FACT accreditation.
View meeting details and register online
QM Series 8: The Digital Age: Controlling Documents within an Electronic System
Wednesday, January 24, 2018
Webinar
This presentation is Wednesday, January 24, 2018, at 11:00 am ET. Rebecca Maddox, Compliance Coordinator at Mayo Clinic Florida, will discuss the following:
- The advantages and disadvantages of using a system,
- How to incorporate an electronic system into your program,
- Considerations to take into account when evaluating systems,
- How to assess a system for compliance with the FACT Standards, and
- What works well with her electronic system and what surprises she encountered.
View meeting details and register online
WMDA-NetCord Webinar: Informed Consent
Wednesday, February 7, 2018
Webinar
This presentation is Wednesday, February 7, at 11:00 am ET, 4:00 pm GMT. Daniel Gibson, Bsc (Hons), LIBMS, and Linda Moss, RM, of Anthony Nolan Cell Therapy Centre, will thoroughly review the different methods banks use to obtain informed consent, and the pros and cons of each method.
View meeting details and register online
FACT Cellular Therapy Inspection and Accreditation Workshop
BMT Tandem Meetings
Tuesday, February 20, 2018
Salt Lake City, UT
The blood and marrow transplant field has been a leader in voluntarily improving quality, and accredited Clinical Programs are currently adapting to several new FACT Standards and procedural changes to the accreditation process. This workshop will provide background on these changes. The morning workshop sessions include major topics such as how to effectively transition to the 7th Edition Hematopoietic Cellular Therapy Standards, CIBMTR data audits, clinical outcomes including center reported causes of low survival, and the accreditation of immune effector cellular therapy programs.
The afternoon session includes two different tracks: New Inspector Training Orientation and Common Citations. The Inspector Training track includes sessions on the FACT accreditation process, what documents to review before an inspection, the ins and outs of performing an onsite inspection, how to conduct an exit interview, and finally, how to make your case via the inspection report. The Common Citations track will review recent deficiencies and corrections related to commonly cited Standards in the areas of quality management, personnel, and donor information and consent to donate. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.
Note: Inspector trainees are required to attend the New Inspector Training Orientation Track.
View meeting details and register online
Cellular Therapy Leadership Course at BMT Tandem – 101
Tuesday, February 20, 2018, 8:00 am – 12:00 pm
Salt Lake City, UT
Do you want to improve your leadership skills? Everyone wins when leaders get better, and this half-day course is designed for that outcome.
In years past, participation in FACT’s leadership workshop has been by invitation. The course is open to anyone who has (or aspires to) a leadership position in cell therapy – whether you direct a transplant center or laboratory, lead a cell collection service or cord blood bank, head a staff of nurses or transplant coordinators, hold an office or board position in a volunteer organization, chair a committee, or have any position in which you are expected to motivate and lead a team.
The highly interactive and participatory curriculum teaches leadership principles including:
- The leader as coach
- Differences between managing and leading
- Basic styles of leadership and how to recognize your own style
- When each style of leadership may be appropriate
- Running and participating in effective meetings
- How to build consensus
- Four proven ways to motivate people
- Effective delegation skills
- How to adapt to change, and even be a change agent
- Understanding and exercising governance roles and responsibilities
Woven throughout the leadership course is an overview of FACT’s organizational structure, purpose, challenges, current programs and accomplishments.
Whatever you lead, this course is designed to help you recognize your leadership skills and acquire new ones that effectively encourage innovation, achieve consensus, build momentum, turn ideas into reality, eliminate distractions and guide a team toward goals.
View meeting details and register online
Advanced Cellular Therapy Leadership Course at BMT Tandem – 201
Tuesday, February 20, 2018, 1:15 pm – 4:30 pm
Salt Lake City, UT
If you completed FACT’s Cell Therapy Leadership 101 course and want more, the 201 course is for you.
This advanced workshop drills deeper into organizational development and leadership skills. Topics include:
- Characteristics of a healthy organization
- Adapting an organization to a changing environment
- Multiplying and diminishing the effectiveness of a team
- Leading from where you are
- Servant leadership
- Effective governing boards
- Legal implications of decision-making and liability and fiduciary responsibilities
- Strategic planning with a focus on outcomes
Participants in the prerequisite Cell Therapy Leadership 101 course in the morning also are eligible to register for the 201 course in the afternoon.
View meeting details and register online
Cellular Therapy Collection Workshop at ASFA Annual Meeting
Wednesday, April 25, 2018
Chicago, IL
This training workshop is designed to explain the requirements for FACT accreditation of cellular therapy programs, with special emphasis on apheresis collection facilities. FACT representatives will be in attendance to 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.
View meeting details and register online
Cellular Therapy Inspection and Accreditation Workshop at ISCT Annual Meeting
Tuesday, May 1, 2018
Montreal, Quebec, Canada
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.
The afternoon session will include two different tracks (to be arranged). All sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences.
View meeting details and register online
