FACT Inspections Amid the Pandemic

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

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

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

FACT-JACIE Stepwise Accreditation Program

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

A joint FACT-JACIE Stepwise Accreditation program has been developed to globally improve hematopoietic cell therapy quality, enhance safety for donors and patients, and make transplantation accessible to qualified patients. The approach consists of three incremental steps to accreditation to enable programs to focus on their quality systems first and ensure operations for patient and donor safety.  The second phase builds on the established foundation to develop a complete quality management program and provide for efficacious care. The final step evaluates the effectiveness of the quality program, ensures reporting to the appropriate regulatory and accrediting agencies, and evaluates clinical outcomes.

Twelve blood and marrow transplant (BMT) centers in Latin America were identified to participate in the initial pilot program.

The first transplant center to be inspected under the FACT-JACIE Stepwise Accreditation Program has offered to share their first-hand experience with the process. While FACT’s standard policy is to not release this information prior to completion of the accreditation process, the program may elect to release results at their own choosing. It is inspiring to hear of the hard work and accomplishments of new programs embarking on their accreditation journey.

The new joint accreditation process also provides an opportunity for continuing education for both applicants and inspectors. At times, subtle differences in interpretation of FACT-JACIE Standards can occur. Professional discussion about potential interpretation is always interesting, educational, and useful to make the next edition of Standards more clear. It also points to the critical role of the Accreditation Committee in maintaining consistency in interpretation and in management of the decisions related to compliance.

The BMT Program of the Private Universitary Hospital of Córdoba in Argentina, was the first centre in Latin America to be inspected as part of a pilot group participating in the FACT-JACIE Stepwise Certification Program. Patrica Abichaín, Quality Manager, explains the preparation process and the inspection that took place on November 20-21.


First joint FACT-JACIE Inspection in Latin America: our experience.

The “Programa de Trasplante de Médula Ósea del Hospital Privado Universitario de Córdoba, Argentina”, member of the Latin America Bone Marrow Transplantation (LABMT) cooperative group, was the first centre in Latin America to be part of the pilot group in the FACT-JACIE Stepwise Certification Program. This project is an innovative proposal for centers in this geographic and economic region to provide a pathway to achieve full accreditation through a step-by-step process.

To be selected for “The Stepwise Certification Program” meant a great challenge for us. It started in July 2017, when we sent the Application Form; a few months later, we received the documentation that should be completed, including the inspection checklist, which became our working tool during several months.

In order to move forward in this process, it was a great advantage to be a joint program (Collection Unit, Processing Unit, and Clinical Unit working together in a single location), strongly motivated by the Program´s Director, who became the leader of a working team formed by the units’ directors, representatives of the units and members of an external company of Quality Consulting. The first task was to perform an internal audit to assess our situation, design a workflow, and finally start making some changes in our way of working.

Completing the inspection checklist was really a huge effort. We spent almost 3 months working on it to achieve the first version that we submitted on March 16, 2018. Fortunately, we had support from FACT and JACIE, who helped us to understand the Standards and demonstrate evidence of compliance.

In the meantime, we began to build a “Quality Management System”. The first step was to name a Quality Manager who wrote a Quality Plan in collaboration with the units’ representatives. This group, our Quality Committee, defined measurable outcomes, performed internal audits, implemented validation plans for critical processes in different areas, worked together with the institution’s Human Resources Management in creating job descriptions for keys positions, adopted both the institution’s System for Document Control (knowing with certainty the importance of this chapter in the scaffolding of a Quality Management System for both the hospital and the transplant program), and developed an Incident Reporting System encouraging personnel to know and use them; involved the  institutional Bioengineering section for control and maintenance of critical equipment, as the most relevant items. To accomplish this challenge, it was extremely useful to have access to the FACT Quality Handbook, the JACIE Quality Management Guide, and documents kindly provided by generous centers from Europe and the United States.

In each unit, Standard Operating Procedures (SOPs) were written, discussed, reviewed and implemented. All of them are first version and we will update them in the near future adopting guidance provided by JACIE and FACT inspectors. Besides writing SOPs, we tried to re-organize the activities with regards to human resources, facilities and equipment. We also introduced simple statistical tools in order to follow-up on our measurable outcomes.

During this time, we reviewed and updated the checklist to find the best evidence for each standard. Closer to the inspection date, we multiplied our efforts to be on time!

The onsite inspection took place on November 20–21, 2018 and was performed by a team of four international inspectors (United States, Spain and Norway) from FACT and JACIE. The inspection was performed in a rigorous and friendly way. To note, this was the first time that inspectors of both accreditation organizations worked together on a joint inspection. We could appreciate subtle differences in the interpretation of some standards, which, in turn, enriched the inspection experience in our opinion. Additionally, we took advantage of the exchange of opinions among colleagues in the field of transplantation, which was very useful for us.

At the end, the closing remarks were extremely helpful; we took note of our strengths and our weaknesses, mostly in Quality Management. We are now waiting for the Inspection Report, but in the meantime, we continue working in accordance with the inspectors’ observations and non-conformities found during inspection.

In summary, this was a great experience. We learned that the most challenging thing was to achieve staff motivation and cultural change, but the inspection itself gave us strong encouragement to continue working in order to achieve the FACT-JACIE First Step Certification in the next few months.

Selection of Cord Blood Collection Sites for FACT Inspections

Posted in :: 2018 Volume 3 :: Saturday, August 18th, 2018

By Cathy Talmadge, FACT Accreditation Services Supervisor

Cord blood collection sites are selected for inspection based on specific variables in order to evaluate compliance with the NetCord-FACT Standards. Cord blood banks should be aware that sites they consider to be “non-fixed” may be inspected during the next FACT inspection depending on the site’s ongoing responsibilities and number of collections performed.

In order to prevent issues upon scheduling the inspection, FACT recommends that cord blood banks inform their non-fixed collection sites that an on-site FACT inspection may occur. The following information may be helpful to non-fixed collection sites who are unfamiliar with FACT accreditation and processes:

  • The mission of FACT is to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients. WMDA-NetCord’s mission is to support, promote, and enhance safety, efficacy, and availability of international exchange of cord blood units and to harmonize global practice of cord blood banking and supply. Accreditation is achieved by demonstration of compliance with the current edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration (the “Standards”). The Standards have been developed to promote quality medical and laboratory practices throughout all phases of cord blood collection, banking, and release for administration to achieve consistent production of quality placental and umbilical cord blood units for administration. They are developed by world-renowned experts in the field including clinicians, collection professionals, laboratory scientists, technologists, and quality experts. The Standards are based on published medical literature, when available, and accepted scientific theory and expert consensus. The Standards define minimum requirements to reach a level of quality worthy of accreditation and allows flexibility in methods/processes to meet requirements.
  • To be eligible for accreditation, a cord blood bank must have processes in place to meet all of the Standards, whether the activities are performed internally or by contract with another facility. The inspection and accreditation process is summarized on the FACT website and includes an on-site inspection of the bank, cord blood collection sites, and cord blood processing and storage facilities. Because they perform a critical step of the cord blood banking process, facilities that collect cord blood units for an applicant bank are inspected during 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.
  • At least one staff member of the cord blood bank pursuing accreditation accompanies the inspector during the on-site inspection of collection sites. The FACT inspectorate consists of experienced individuals active in the field who have a strong and vested interest in ensuring the availability of the highest quality cord blood units for administration. The inspectorate includes transplant physicians, cord blood bank directors and medical directors, cord blood collection directors, and cord blood processing facility directors. Inspectors complete an inspector training course, pass a written exam, participate in at least one inspection as a trainee inspector, and participate in ongoing education.
  • The cord blood bank will work with the selected collection sites during the preparation for inspection, including document submission, compilation of evidence, and scheduling the inspection. Any deviations noted during the inspection will be reviewed by the FACT Accreditation Committee comprised of leaders in the field of cord blood banking. The cord blood bank will be provided with the committee findings and is responsible for correcting any deficiencies identified. FACT encourages collection sites to maintain close communication with the cord blood bank as they prepare for an inspection.

Requirements for Qualifying Third-Party Manufacturers of Cellular Therapy Products Regulated Under U.S. INDs or BLAs

Posted in :: 2018 Volume 1 :: Thursday, February 15th, 2018

In light of the recent licensing of immune effector cell (IEC) products in the United States, this is an opportune time to continue education regarding third-party manufacturers in general.  The manufacturing process for many novel cellular therapy products, including research and licensed cellular therapy products, involves multiple entities: holders of Investigational New Drug (IND) applications for research or Biological License Applications (BLA) for licensure, collection facilities, and processing facilities. Clinical units may be involved with one or more of these facilities.

There are three main responsibilities when third-parties are involved in the manufacture of a research or licensed product: verify regulatory oversight, qualify the vendor or service provider, and define responsibilities.

Though many questions from organizations regarding these requirements are specific to IEC processes, the information below can also be used as guidelines for other types of cellular therapy products.

Verify Regulatory Oversight

  • The participating manufacturer (e.g., collection or processing facility) is responsible for verifying that the contracting entity for whom it performs services possesses an approved IND or BLA.
  • The Clinical Program is responsible for verifying the manufacturer responsible for the entire manufacturing process (e.g., a commercial manufacturer) possesses an approved IND or BLA.

Qualify the Third-Party Manufacturer

  • The IND or BLA holder is responsible for verifying that any facility performing a step of manufacturing complies with GMP and GTP requirements as applicable (see 21 CFR 1271.150(c)(1)(iii)).
  • If the IND or BLA is held internally by a FACT-accredited facility, then the facility must perform this qualification and provide documentation to FACT inspectors.
  • If the IND or BLA is external, i.e., held by a third-party investigator or manufacturer, this qualification is outside the scope of FACT accreditation and the FACT-accredited facility is not required to provide documentation of this type of qualification to FACT inspectors.

The participating manufacturer must participate in site visits from the IND or BLA holder and provide the level of service required of that entity, including compliance with GMP and GTP requirements as applicable. FACT-accredited facilities that participate in manufacturing for external IND or BLA holders must provide FACT inspectors evidence of complying with these requirements as required by applicable laws and regulations.

  • The Clinical Program must perform vendor qualification of the IND or BLA holder. It is the FDA that monitors regulatory compliance, and the Clinical Program only needs to perform vendor qualification. Programs must verify the IND or BLA holder meets its needs in regards to many areas of cellular therapy, including labeling processes (label content applied by whom and how), level of service (turnaround times, customer inquiries), and other metrics defined by the program. Documentation of this qualification must be provided to the FACT inspection team.
  • It is acceptable to delegate this activity to the Processing Facility so long as there is robust communication between the program and facility, which should be obvious in documentation.

Define Responsibilities

  • The level of participation of the clinical service in manufacturing an immune effector cell product varies. Regardless of where the product is collected or manufactured, responsibilities must be clearly defined.
  • If a Clinical Program is responsible for collecting cells or preparing the IEC product for administration, or if independently FACT-accredited cell collection and processing facilities contract with a manufacturer, FACT Standards for collection and processing apply to the steps performed.
  • If products are received directly by the Clinical Program or intermediary facility (e.g., blood bank, pharmacy) from a third-party manufacturer, the following responsibilities must be defined at a minimum: chain of custody, product storage, verification of product identity, and management of adverse events. Additional responsibilities will be included in the new edition of FACT Standards to be published in March 2018.

FACT Announces 2017-2020 Strategic Plan

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

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.

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.

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.

Organizational health is one of FACT’s greatest strengths.

The Role of Medical Records During On-Site Clinical Program Inspections

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

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.

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

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.

Michele Sugrue Outlines Her Recipe for Successfully Performing FACT Inspections

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

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!

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

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



Help Your Inspectors Help You

Posted in :: 2017 Volume 1 :: Thursday, January 26th, 2017

On-site inspections are understandably stressful experiences. Organizations essentially invite others to come to their sites, look through their documents, watch their work practices, and record observations. Organizations that voluntarily pursue FACT accreditation want to do well, and it is natural to feel nervous about what inspectors may find while assessing their programs.

When preparing documentation for inspector review, it may be instinctively enticing to avoid showing inspectors everything. Limiting what inspectors see limits the amount of deficiencies they find, right? Wrong. Although it seems counterintuitive, more citations result from inspectors not able to find evidence of compliance.

Do not think of an inspection as a day to avoid doing anything wrong. Think of it as a day to proudly show all that your program has accomplished! The easier it is for inspectors to find and review documents, the easier it is for them to check “Compliant” on that ubiquitous inspection checklist. Showing documentation upfront on the day of inspection will avoid extra time and effort to describe the documentation when responding to deficiencies afterward.

Therefore, be ready to show inspectors audits, adverse event investigations, and urgent medical need documentation for ineligible donors. The purpose is not to show the inspectors any shortcomings; the purpose is to show inspectors your approach to quality management and continuous improvement. Organizations that act like they have something to hide will appear to have something to hide. Confidently showing inspectors your quality documents, procedures, and investigations demonstrates a commitment to quality.

FACT and its inspectors want organizations to do well, and that does not end with an accreditation certificate. The ultimate goal of FACT accreditation is to continuously improve. The more you show us, the more we will be able to help you and the better value you gain from the accreditation process.

FACT and CIBMTR Announce Joint Data Audit Program

Posted in :: 2016 Volume 2 :: Wednesday, October 12th, 2016

FACT and CIBMTR are pleased to announce our long-awaited collaborative program of data auditing, designed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited programs. In this collaboration, the joint FACT-CIBMTR Data Audit Committee acknowledges the importance of complete and accurate data for self-assessment in individual hematopoietic cell therapy programs, for research and outcome reporting, and for compliance with FACT-JACIE Standards.

The essential elements of the collaboration are:

  • FACT clinical inspectors will no longer perform a data audit at the on-site FACT inspection. This will eliminate the need for data sheets to be prepared only for FACT inspectors, and allow the clinical inspector to focus on adequacy of corrective actions and quality improvement.
  • All verification of the accuracy of data against source data will be performed by the CIBMTR audit teams on site according to their current practices and schedules. The current CIBMTR process will not change.
  • The FACT-CIBMTR Data Audit Committee will review CIBMTR audit reports and corrective action plans to assess compliance with Standards, implementation of effective corrective action, and improvements.
  • Timeliness and completeness of data submission will also be assessed by the Committee using CPI reports from CIBMTR indicating “in good standing”.

On-site, FACT clinical inspectors will have access to this information and CIBMTR reports. The expectation is that clinical inspectors will look at documentation of internal data audits and implementation of corrective action plans (CAP). Where data management is outstanding and there are no corrective action plans to review, the on-site inspectors may ask to see these commendable practices that have resulted in exemplary data management.

Over the years, both FACT inspectors and CIBMTR auditors have continued to observe some programs and personnel who struggle with data accuracy and completeness. We hope that intensified support between inspections, increased emphasis on implementation of CAPs, and follow up to document continuous improvement will assist programs in data management improvement. We also hope the expertise in commendable practices in data management can be more widely shared and adopted where problems are being encountered. Ultimately, successful FACT accreditation will depend on satisfactory progress through these stages.

The following are answers to frequently asked questions. There are still some details to be finalized; however, do not hesitate to contact Heather Conway, Quality Manager in the FACT office (heather.conway@unmc.edu or 402-559-1968) if you have concerns or questions.

  • When will this start?

The new data audit program will be phased in starting late fall, 2016. Programs submitting an Annual Report or Renewal Application to FACT after this time will find new questions related to data on those reports. Programs that have already submitted renewal applications will notice there is no change in the upcoming inspection. There may be some overlap in processes as reports and applications are not always received in an orderly manner.

  • How does this help my program?

FACT-accredited programs will no longer have to prepare data sheets for review by the on-site FACT inspector and will not have a data audit during the on-site FACT inspection. Programs will have the opportunity for enhanced review of corrective action plans and assistance with self-audits and other follow up to ensure compliance and improvements are made following any CIBMTR audit. Programs with outstanding Data Management will have the opportunity to share their expertise with their colleagues in webinars, writing, or other educational forums and be recognized for their accomplishments. On-site clinical inspectors will review internal quality management activities that support improvement in data management. Commendable practices in Data Management will be available to programs and persons to adopt as appropriate to their setting.

  • What will this cost us?

There is no added cost to accredited programs for this collaborative process.

  • How will the FACT inspectors be trained?

Over the next months, webinar presentations and written materials will be made available to current FACT inspectors. FACT Staff will observe portions of a CIBMTR audit to gain understanding and assist in training. This collaborative program will also be covered at the FACT Inspector Training at Tandem Meetings in February 2017. FACT Coordinators will be trained and will work with each program and inspector to ensure needed information is available.

  • If we have had difficulty with our CIBMTR audits, will we lose our accreditation next year?

Not immediately. Initially, centers will be given a grace period to show improvement in critical field and random error rates. During this time, programs will be expected to learn from prior difficult audits, design appropriate investigations, implement effective corrective actions, and follow up to ensure that improvements are sustained. This new process is designed to help you identify the issues that may be barriers to improvement and to develop strategies to be successful. When this process has been fully implemented, FACT-accredited programs will be required to remain in good standing with the CIBMTR data audit program.

  • How will the FACT and CIBMTR schedules change to accommodate this program?

There will not be a change in either FACT or CIBMTR schedules for on-site visits. CIBMTR audits will remain every four years as scheduled (unless you request and pay for an interim special audit). You will respond to these audits to the principal auditor as usual and according to the time frames defined by CIBMTR. FACT will receive information from you annually, and will manage the processes on an on-going basis, depending on the needs of the program. FACT on-site inspections will continue to occur every three years.

  • Will the CIBMTR auditors know this is happening?

Yes. This process is intended to be completely transparent. Over the next several months, educational presentations will be available for CIBMTR staff related to FACT-JACIE Standards, the FACT accreditation process, and this data management collaboration. The committee charged with implementation of this program is a combined FACT-CIBMTR committee, with representation from both organizations.

  • If we submit a corrective action plan to CIBMTR related to consent issues, will FACT review these also?

No. While FACT does have Standards related to informed consent, the consent issues managed by CIBMTR are outside the scope of this data project.

  • If we fail a CIBMTR audit, will we have to request and pay for a special interim audit?

Not necessarily. This option is open to you; however, there will be other mechanisms defined through which you should be able to demonstrate appropriate implementation of corrective action and improvements in data management.

  • Will we still have to submit a patient accrual list to FACT?

Yes. The patient list is used in many ways by the FACT staff to document new patient numbers, pediatric and adult recipients, and types of transplants.

  • What happens if I disagree with the CIBMTR audit results?

There is no change in the processes available through CIBMTR to appeal or further discuss the results, either individually or cumulatively. FACT will not intervene in these processes.

Experienced Inspector Motivated by Helping Other Programs Succeed

Posted in :: 2016 Volume I :: Thursday, April 14th, 2016

Meagher Photo for Insight Story Cropped 2Richard C. Meagher, PhD, is the Section Chief of Cell Therapy Laboratory Services at Memorial Sloan Kettering Cancer Center in New York, NY. Although Dr. Meagher is a research scientist by day, he is also a FACT inspector, and has been since the inception of the FACT accreditation process. He performed his first inspection in the year 2000, and has since completed 48 inspections (or an average of 3 inspections a year). In addition to volunteering as an inspector, he is a co-chair of the FACT Cellular Therapy Processing Facility Standards Committee and a member of the FACT Cellular Therapy Standards Steering Committee.

Becoming an Inspector

Dr. Meagher was motivated to become a FACT Inspector for the educational experience. He has visited a variety of programs both small and large with an amazing degree of heterogeneity in complying with the Standards. Given the experience he has gained as an inspector, programs in turn frequently ask for his help to achieve compliance with the Standards. The following are additional benefits and advantages Dr. Meagher believes FACT inspectors enjoy:

1. Involvement with FACT helps inspectors remain current with the regulations and provides ideas for complying with them.
2. Inspectors’ own programs benefit from their gained experience.
3. Inspectors have many opportunities to meet their peers and form new relationships.
4. FACT provides an incredible amount of support to inspectors free of charge, such as webinars, advice and recommendations about laudable practices, and the online FACTWeb accreditation portal.

If considering whether to become a FACT inspector, Dr. Meagher says, “Just do it.” He believes the benefits and rewards of becoming an inspector far outweigh the time commitment spent preparing for and conducting an inspection. “You will become much more knowledgeable about the Standards, how to implement them, and how to successfully conduct and/or pass an inspection. Remember that your responsibility as an inspector is to help improve the program and correct or modify identified deficiencies. The inspector experience teaches you very quickly that your peers are looking for help to improve; as an inspector you provide that help. “

Advice to Current Inspectors

Dr. Meagher is one of the most experienced FACT inspectors. Given the number of inspections he has performed, he has a lot of advice to offer current inspectors:

1. Use the tools that FACT provides to you and certainly take advantage of the collective knowledge of the FACT office staff, which is exceptional.
2. When requested to perform an inspection, it is important to do your homework BEFORE you show up for the inspection. In the new electronic age it is easier than ever to conduct a full review of the documentation that is initially required by the FACT office prior to the inspection.
3. Use your inspection preparation time to identify issues that will need further clarification, and, if necessary, request additional information before conducting the inspection.
4. Use the previous accreditation reports to help guide your current inspection, with an eye on new or revised standards that may have been released.
5. Establishing a cordial atmosphere is critical to conducting a successful inspection. The inspected program or facility personnel will likely be nervous. Assure them that your responsibility is to help.
6. During the inspection it is the inspectors’ responsibility to ask questions to clarify any perceived issues. A useful tactic is to ask the question from different perspectives to make sure the program personnel understand what information you are seeking.
7. Examination of the quality management plan and how it is implemented lays a foundation for assessing compliance with the Standards.

Advice to Accreditation Applicants

1. Starting the preparation process for an onsite inspection early is the ultimate key to success.
2. Check for applicable new or revised standards and conduct a gap analysis to determine which standards apply, and whether you have documentation to substantiate compliance.
3. Assemble a binder with the applicable standards indicated and the corresponding documentation.
4. The inspection process is normally only a one day event. Making sure that the inspector has all of the information needed to make an informed recommendation for accreditation rests with the program or facility.
5. Commonly observed deficiencies are related to communication among personnel across departments and quality management activities.

FACT is incredibly grateful to Dr. Meagher’s commitment to FACT and the organizations he has served as an inspector. We encourage all inspectors to greet FACT inspections with the same enthusiasm he displays.

Would you like to share your advice and experiences from serving as a FACT inspector? Submit your story on the FACT website.