1. education

Abstracts Education Day
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20141106-EDUC-abstracts
2014-09-09
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Abstract 1 Armenian Youth Donor Education Program Initiative
Authors: Frieda Jordan, Sevak Avagyan, Mihran Nazaretyan, A. Hyussyan Over the last 15 years of intensive work we’ve recruited about 25, 000 stem cell donors in Armenia and from Diaspora. Such a donor population allows us to become a consistent member of international stem cell and bone marrow donor society. At the meantime, we have two priorities to keep up with constantly. That is continuously to renew the composition of our donors to prevent negative influence of aging by recruiting new young males and females who have commitment and values to gift their cells for those in need, and, secondly, to expand the size of our donor pool to reach our target – 30, 000 donors, which is just the first frontier. On the way to reach the target set, we’ve prepared a school education program to educate 16‐18‐year old youths and their families on importance of donating blood and bone marrow cells to save lives of those in need. In 2014 we have signed a Memorandum of Understanding and launched a 4‐hour educational program in Ayb Learning Hub Foundation (a high school) and in Mkhitar Sebastiatsi high‐school facility in Yerevan, Armenia. The aim was to educate a substantial cohort of teenagers in basics of blood and stem cell donation, provide them specific knowledge regarding blood and stem cell donation and support their ability to generate publicity as informed volunteers Around 150 high school students have passed primary knowledge assessment on the subject and then attended classes. In the mean time, some of the most committed students participated in off‐campus donor drives and joined our HLA‐typing laboratory for one week hands‐on training. We assume these students would be able to make informed decisions to become blood and stem cell donors in the future and be of help in recruitment of potential donors in the communities. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 2 Bone Marrow Registry in Nigeria (BMRN): Two Years’ Experience in Searching for Unrelated Stem Cell Donors for Transplant Patients. Authors: Dr. Sunday Ocheni, Dr. Ifeoma Okoye, Mr. Seun Adebiyi
Hematopoietic stem cell transplantation can treat over 70 hematologic and immunologic disorders. However, sibling donors are available for only a fraction of transplant candidates, forcing the majority of patients to rely on unrelated HLA compatible donors. Patients of African ancestry are severely disadvantaged in comparison to their Caucasian counterparts when seeking unrelated donors. In the USA, for example, < 17% of African‐American patients can find unrelated donors while Caucasians enjoy > 70% success. This disparity stems from the greater HLA diversity among patients in the African diaspora, relative to Caucasians, as well as from the scarcity of unrelated donors of African descent. Black donors comprise only 7% of the NMDP. Only two countries from Africa are on Bone Marrow Donors Worldwide database. This report describes the experience of the Bone Marrow Registry in Nigeria (BMRN) launched on February 24, 2012. Design and methodology: Since setting up the Registry, the BMRN has received requests for donor searches from several countries. We hereby report the search requests and the outcomes of the donor searches. Original data and results: Total Number of Patients: 38 Potential Matches Found: 15 Countries Number of Requests
South Africa 1
Nigeria 12
USA 4
Italy 3
Dubai 1
Germany 3
Unknown 1
India 6
France 1
Kuwait 1
Egypt 2
China 1
Singapore 1
Toronto 1
TOTAL 38
Conclusion: By helping patients find a bone marrow match, the BMRN will make it possible for them to access life‐saving treatment. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 3 Donor weight is the most important predictor of bone marrow harvest yield in unrelated donors Authors: Chloe Anthias, Rebecca Arkwright, Annelies Billen, Salmah Mahmood, Alejandro Madrigal, Bronwen Shaw Introduction The factors influencing bone marrow (BM) harvest quality and total nucleated cell count (TNC) achieved are poorly understood. As the number of BM harvest procedures falls, concerns are raised around maintaining expertise in this area. We investigate the factors influencing cell dose and harvest quality. Materials & Method 110 consecutive BM harvests of healthy UDs were performed according to Anthony Nolan protocols in four collection centers. Harvest quality was defined as TNC/ml collected. Univariate analyses of factors influencing the TNC and harvest quality were performed using Chi squared or Fisher’s test. Results 110 BM harvests were performed in 80 male and 30 female donors. The median TNC requested was 4x108/kg, and median harvested TNC 4.2x108/kg recipient weight, with the requested TNC achieved in 50% harvests. Higher volume harvests (>1200 mls) were significantly less likely to achieve TNC> 4x108/kg (38% vs 70% p=0.001), as were harvests with a procedure time over 30 minutes (p=0.037). The only donor factor influencing yield was donor/recipient weight discrepancy: only 18% BM harvests from donors lighter than their recipient achieved TNC >4x108/kg compared to 62% harvests from donors who were heavier than their recipient (p=0.001). Harvests from donors>40 years were more likely to be lower quality (p=0.036). Significant variation between the 4 collection centers was also observed regarding both harvest quality (p=0.014) and volume collected (p=0.035). Conclusions Donor weight strongly predicts bone marrow harvest yield; we recommend that when multiple matched UDs are available, a heavier donor should be selected. Procedure factors including large volume harvests and long procedure times reduce the likelihood of achieving the requested TNC, and significant variation was seen between centers. Given the declining number of requests for BM harvests, it is crucial these are performed by the most experienced centers and that systems exist to ensure operators retain their expertise. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 4 Standard for the Global Registry Identifier for Donors (GRID)
Authors: Ashford, Paul; Britton, Ian; Distler, Pat; Foeken, Lydia; Maiers, Martin; Querol, Sergio Purpose Given the global nature of the work done by hematopoietic stem cell donor registries, a system to uniquely identify potential donors on a global scale is needed to facilitate communication and prevent errors in identification of donors. A standard machine‐readable format for a Global Registry Identifier for Donors (GRID) that can be used by electronic process control systems, as well as a standard format for the human‐readable version, is under development. Methods: WMDA has signed a Memorandum of Understanding with ICCBBA to assign and manage the register of registry identifiers and support the development of associated standards documents. Representatives from WMDA and ICCBBA have identified three phases for the project: Phase 1 – Registry identifier allocation rules, GRID format, GRID eye‐readable presentation, and GRID data structure for electronic transfer are defined. Guidance for registries for mapping local identifiers to the GRID are developed. Phase 2 – EMDIS and BMDW databases and messaging standards support GRID. Use of GRID in communication between registries is recommended but not required. Phase 3 – GRID is a mandatory field in communication with EMDIS and BMDW databases and in communication between registries. GRID is used as the key donor identifier on search reports. GRID is used on product labels when a donor identifier is required. Results: Phase 1 of the project is in progress. The format for the GRID will be a 4‐character (all numeric) registry identifier assigned by ICCBBA followed by a 15‐character (numeric or uppercase alpha) donor identifier assigned by the registry for a total of 19 characters. In the human‐readable form, the alphanumeric sequence will be divided into blocks of 4,4,4,4,3 to assist in manual transcription. Leading zeroes would be used for donor identifiers less than 15 characters. In the human‐readable form, a modulus 37‐2 check character will be displayed. This can be used to ensure correct data entry should the number be entered into a computer system via a keyboard. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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In electronic communications, the characters &,3 will be used to identify the number as containing a Hematopoietic Stem Cell Registry GRID. Code 128 will be used if the GRID is to be represented in a linear bar code and Data Matrix will be used if the GRID is represented in a two‐dimensional bar code. Conclusion It is anticipated that implementation of a GRID following the 3‐phase project plan will take 3‐5 years. The GRID has been designed to allow registries to insert their current donor identifiers (alphanumeric characters only) into the GRID to facilitate the adoption of the new identifier. For example, a registry has been assigned the identifier 3054 and currently has assigned the identifier A12345 to a donor. The GRID would be 3054 0000 0000 0A12 345. It is believed that the GRID will improve electronic communication, traceability, and accuracy in identifying potential donors by standardizing systems across the globe. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 5 Transient Myeloproliferative Disorder in a Normal Infant Cord Blood Donor
Authors: Phil Paul, PhD1, Marcie Finney, MS1, Matt Kalaycio, MD2 1) Cleveland Cord Blood Center, Cleveland, OH 2) Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH Background Transient Myeloproliferative Disorder (TMD) is usually associated with Trisomy 21 (T21) and is present at birth in ~10‐20 % of Down Syndrome (DS) infants, but rarely observed in non‐DS neonates. We report a case of TMD in a phenotypically normal infant and cord blood donor. TMD in neonates is associated with clonal chromosome aberrations in the blast cells, and usually resolves spontaneously with the disappearance of the clone. Risk of recurrence and conversion to acute megakaryoblastic leukemia is high in DS, but unclear for non‐DS patients. Materials and Methods Cord Blood was collected from an apparently normal infant in whom TMD was discovered postnatally. An automated complete blood count was performed on the cord blood upon arrival at the laboratory. After TMD was diagnosed, flow cytometry and karyotyping were performed on peripheral blood samples, and microarray analysis (NimbleGen CGX) was performed on the whole genome. Results CBC of the cord blood showed an elevated monocyte count (7.57 x103) with an inverted lymphocyte to monocyte ratio (L/M=0.51, normal average L/M=~ 3.5). On postnatal day 2 a diagnosis of TMD was made with 17% myeloblasts in peripheral blood with relative neutropenia. There were no features of DS. Initial and repeated karyotyping revealed a normal 46XY male. The myeloblasts from peripheral blood were identified by flow cytometry as megakaryoblastic with the following markers: CD 4, 7(dim subset), 16(dim), 33, 38(dim), 41, 42B, 45(dim), 61, and 123. The postnatal course was otherwise unremarkable and the myeloblastosis resolved by postnatal day 27. Microarray analysis has been negative to date. Conclusions TMD is common in DS neonates with potential for later recurrence and a~20‐30% probability of progression to acute megakaryoblastic leukemia. Although TMD in non‐DS infants is apparently rare, its appearance and resolution within the neonatal period suggests some cases may go undetected. Monitoring the L/M ratio of cord blood could be useful as an early screen for myeloproliferative disorders, as well as for immunodeficiency syndromes resulting in significant lymphopenia. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 6 Stem Cell Product Batch Production / Lot Release Record Review – A Registry’s Perspective. Authors: Elizabeth A. Crews, Jay Feinberg In a proactive approach to implement elements of good manufacturing practices, the Gift of Life Bone Marrow Foundation introduced quality steps into the multifaceted process of advancing a donor through workup and donation. In order to meet production record review requirements, Gift of Life utilizes a comprehensive step by step checklist and audit process that is completed for each donor requested for donation. The checklist provides instructional support to Donor Services staff and includes management and quality reviews throughout the process to ensure all tasks are completed as required prior to, on the day of and post donation. Donor Services management reviews occur upon completion of the following critical control points:  consent and health history questionnaire  donor physical examination and donor eligibility and suitability determination The production chart is reviewed prior to the day of collection by Donor Services management and Quality Assurance. Each required task must be completed with all accompanied sources documents available for review. These reviews serve as the “batch release” review for the product which is collected and distributed the following day. Because of the dynamic, time sensitive and physically distant nature of the donation, a separate checklist is provided to the collection center personnel for product labeling, verification and packaging prior to product release. After the one week post donation donor follow‐up, the entire chart is forwarded to Quality Assurance for a complete production chart audit. Discrepancies identified throughout are brought to the attention of Donor Services management for investigation and corrective action. As an additional quality measure, a separate audit checklist is used for the Quality Assurance portion of the review. This process meets the record review objective and has resulted in comprehensive production charts that are reviewed / approved concurrent with the workup and donation workflow process. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 7 HLA check on Workup level: Supporting patients with unfavorable donors
Authors: Sandra Bochert; Jennifer Wuchter; Jan Hofmann; Andrea Ziegler; Bettina Kesten; Brit Spindler; Gabi Rall; Julia Pingel; Alexander Schmidt Introduction: DKMS German Bone Marrow Donor Center receives workup requests with different degrees of matching. The majority of WU requests is submitted for patients that are a 10/10 match with their donor. However, sometimes the degree of matching is lower and in very rare cases even bears a risk for the patient. To improve quality and safety for the process of finding the best suitable donor, DKMS has implemented a system checking all incoming WU requests for suboptimal degrees of matching and searches for better matching donors within our database. Methods: Whenever a workup request is imported, the system checks each locus for potential mismatches between donor and patient. In case of an insufficient degree of matching, a couple of actions are triggered, whereas insufficient matching is defined as follows: 7/10 or less for 5 comparable loci between patient and donor 6/8 or less for 4 loci 4/6 or less for 3 loci In case of insufficient matching, whenever the electronic donor chart is opened, the workup coordinator will get a pop up message, which informs him to put this request on hold until receiving further feedback from our HLA Service Team. In addition the HLA Service Team receives a To Do to check the incompatibility. The patient and donor HLA data will be checked manually on the original workup request forms if available. If there is still an insufficient matching afterwards, the HLA Service Team initiates a search within our database using the available patient HLA data. The TC or HUB will be informed by the WU coordinator in case donors with a higher degree of matching are available. With help of this automated check we have also reduced the risk of requesting the wrong donor for workup by accident. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 8 Withdrawn 20141106‐EDUC‐All abstracts Edu day 20141106-EDUC-abstracts
2014-09-09
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Abstracts Education Day
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2014-09-09
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Abstract 9 Quality of HLA typing results – the key to a registry’s success
Authors: J. Pingel, J. A. Hofmann, D. M. Baier, V. Lange, I. Böhme, A. H. Schmidt
High‐quality HLA typing is critical for efficient donor searches, even in times of haplotype frequency‐
based matching algorithms. A variety of typing methods exist providing more or less reliable results. Tools such as validity checks of HLA results (to discover wrong data entries or deprecated alleles) and comparisons of typing quality of different results for one donor need to be standard in registries / donor centers. The DKMS‐family today registers almost 4.7 million potential donors. Since its foundation in 1991, DKMS German Bone Marrow Donor Center used methods from serology, over SSO/SSP and Sanger Sequencing to Next Generation Sequencing (NGS) of HLA. To determine the reliability of NGS HLA typing results, we used CT results and analysed reported discrepancies. Between July 2013 and September 2014, 1996 CT results were received by DKMS Germany for donors typed at recruitment in 6 loci by NGS. In total, we found 22 discrepancies in 10,396 loci. Only 3 loci had a wrong initial NGS assignment. All 3 cases were related to wrong homozygous / heterozygous results, had been marked in the lab software as questionable results and could be corrected by repeated typing. The observed error rate of 0.03% is comparable to earlier results for Sanger sequencing (0.03%) and much lower than error rates in SSO/SSP (0.6%) and serology (5.4% and higher). In terms of resolution, NGS shows best results. In average, an amplicon‐based NGS typing approach leads to 97.6% high‐resolution results in class I and 100.0% in class II. It can be shown that better typing profiles in terms of resolution and available loci lead to higher donation rates. It is thus high time for everyone to move beyond HLA‐A, ‐B, ‐DRB1 and to use reliable and cost‐efficient NGS HLA typing at donor recruitment and for prospective typing projects. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 10 16 AND 17 YEARS OLD DONORS SHOW SIGNIFICANTLY LOWER ATTRITION RATES THAN OTHER AGE GROUPS AT THE CONFIRMATORY TYPING STAGE Authors: A. Gallego, A. Billen, J.A. Madrigal, B.E. Shaw
INTRODUCTION In order to improve the quality of the register, Antony Nolan (AN) began recruit donors aged 16 and 17 in October 2012. The objective of this work is to assess the donor attrition rates at CT stage of this age group compared to other age groups. METHODS All CT requests for Anthony Nolan donors in 2013 were reviewed, and the outcomes (completed or cancellation due to donor or patient reason) were documented. Donor characteristics were documented. RESULTS 4207 requests were performed in 2013 and 2390 were completed. All donors within this time period join by providing a saliva sample. We excluded the CT requests that were cancelled for patient reasons in the analysis (n = 232). Thirteen 16‐17 years old were requested at CT stage. 6/13 donors were male donors. Only one CT request was cancelled for donor reasons (a young man, temporarily unavailable due to being deployed in the army), while all others were completed. Within the completed group the duration on the register was 19 days to 6 months and, the average turnaround time from the donor contact to the blood sample received was 11 days (range 4 ‐19) . In the four 16‐17 year old donors who have donated so far, no adverse reactions were observed and excellent yields have been obtained. CONCLUSION Anthony Nolan is the first register to routinely recruit donors aged 16 and 17. These donors show very low rates of donor attrition overall, despite all joining by providing saliva samples. Preliminary data show that donation in this age group is safe. In conclusion, these data show that donors aged 16 and 17 make excellent donors and we feel that the recruitment of this age group should be considered by other registries. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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2014-09-09
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Abstract 11 Removal of mandatory donor deferral for men who have sex with men: guidance from the UK Advisory Committee for the Safety of Blood, Tissues and Organs Authors: Robert Lown, Rachel Pawson, Stephen Thomas, Allan Pacey, George Galea, Eithne MacMahon, John Casey, Andrew Broderick and Lorna M Williamson, on behalf of the SaBTO working group on MSM Tissues and Cells. In 2012, the Advisory Committee for the Safety of Blood, Tissues and Organs (SaBTO) in the United Kingdom reviewed the mandatory lifetime deferral of men who have sex with men (MSM) as blood donors, resulting in a reduction in deferral to one year following last sexual encounter. The following year, a new committee was convened to discuss the deferral of MSM tissues and cells donors, including haematopoietic stem cell (HSC) donors. Evidence in both the UK and abroad was reviewed, and a thorough risk‐based approach was adopted, identifying those factors that would determine the overall risk/benefit balance. Infections of interest were explored, and data on epidemiology, association with MSM and testing regimens were reviewed. HSC donation was deemed to be life‐saving, but the supply was significantly limited by the requirement for stringent HLA‐matching and sufficient stem cell dose (in the case of cord blood), and the survival advantage associated with selected secondary donor characteristics, such as age and CMV status. Although the risk of transmission of viral infection is extremely high if an affected donation is used, modern screening techniques such as viral nucleic acid testing, as well as detailed donor questionnaires and counselling, were deemed to reduce the risk of disease transmission to extremely low levels. However, the committee acknowledged that data to support this risk assessment were sparse, mainly due to low numbers of donations compared to blood donation, and that emergent infection remained a risk. No data on donor compliance were available. In summary, the committee felt that the risk of inadvertent transmission of viral infections such as HIV was significantly outweighed by the benefit of using a donation from a well‐matched MSM donor, and so no fixed deferral period was required. However, ongoing biovigilance is essential, and transplant centres should be informed of an MSM‐related risk assessment. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 12 Management of a Web‐Based Reference Page: Providing Users Quick Access to Controlled Documents and Frequently Used Resources Authors: Amy Lindberg, Pam Robinett Organizing a wide variety of resources in a user‐friendly, logical and maintainable way is a challenging process. The NMDP has a robust Document Management System (DMS) in place to manage SOPs, forms and aids. Within the Case Management department, additional standardized templates and resources are available for staff use. To facilitate a single point‐of‐access for new or updated documents stored in the DMS or other resources available to department staff, Case Management has developed and maintained a web‐based Case Management Reference Page with links to commonly used DMS and non‐DMS documents. Users experience the Reference Page as a web‐based landing page with hyperlinked tabs. Each tab is a heading – such as Search, Workup & Collection, Contacts, Training, or SOPs – transporting the user to a sub‐page containing hyperlinked documents and resources related to the listed heading. Behind the scenes, each hyperlinked document is saved either in a centrally managed, designated and protected department drive or linked directly to documents in the DMS system. Administration of the Reference Page is as simple as maintaining a Microsoft Excel file – including the landing page and subsequent heading tabs – containing hyperlinks to each resource, then saving the page as an html file. The benefits of this model include:  Easy, single point‐of‐access for DMS and non‐DMS documents  Minimal software support and resource allocation  Designated administration, including processes to request document addition, revision, or removal  Ability to update resources in a single location for immediate distribution to all staff  Protected status of documents to prevent unauthorized updates and changes  Capacity to integrate and hyperlink to DMS documents automatically  Centralized file storage and web‐based access Despite the significant challenges surrounding document management, Case Management has implemented and maintained a Reference Page that significantly supports operations and can be utilized in conjunction with a Document Management System. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 13 Withdrawn 20141106‐EDUC‐All abstracts Edu day 20141106-EDUC-abstracts
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Abstract 14 Product quality measures: positive cultures in HPC, Marrow products
Authors: Catherine Newcomb, Ruth Bakken, Dr. John Miller
Since 1987, the National Marrow Donor Program (NMDP) has facilitated the collection and transportation of volunteer, unrelated donor hematopoietic stem cells to transplant centers. As part of ongoing interest in providing quality products, the NMDP requests that network partners, including transplant, donor, collection, and apheresis centers, notify NMDP of any product‐related issues. Quality representatives then initiate an investigation to gather further information, identify contributing factors, determine risk, and assess whether process changes are required. As a result of this investigation, data on multiple quality‐related product issues, including the incidence of positive marrow product cultures, has been collected. For fiscal year 2013, 6.1% of the 1,223 marrow products facilitated by NMDP had a positive product culture identified at the transplant center and reported as a quality‐related issue. Of these, six infusions resulted in temporally associated reactions, half of which were attributed to non‐product causes; one infusion resulted in sepsis, potentially related to product contaminant. For products with a positive culture, NMDP pursues an investigation with both the collection and transplant centers to identify contributing errors, practices, and/or equipment. Additionally, the transplant center and collection center‐specific rates of positive product culture are reviewed and compared to the expected rates, based on network average and given the volume of the centers involved; for centers in which a systemic factor is identified, or for which their rate of positive product cultures differs significantly from expected, additional corrective actions may be pursued. These actions range from requesting that the center make adjustments to their procedures to temporarily suspending operations with a center, depending on the level of risk, among other factors. Bacterial contamination of hematopoietic cell products and associated clinical adverse events are rare; careful investigation of these events may identify factors that can be modified to ensure the highest quality products for patients. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 15 Tracking Occurrences at the NMDP: A method to track incidents that do not affect the Safety, Quality, Identity, Purity or Potency (SQuIPP) of a Product. Authors: Pam Robinett Introduction: Although the NMDP has an FDA‐compliant software application to track quality incidents, it was determined that a different system was needed to capture and monitor the less critical, but still important problems (occurrences) that do not qualify as quality incidents. Capturing these occurrences is an important quality activity to help identify and quantify problems that contribute to inefficiencies and waste. Methods: An interdepartmental group convened to determine key elements that should be captured and the key reports that should be generated. The NMDP IT department suggested the software application used to track NMDP software/hardware/user access complaints (Service Now workflow and ticketing application‐ http://www.servicenow.com/products.html ) could be customized to build a database to track these occurrences. NMDP began tracking Occurrences on October 1, 2012. All staff in the Operations Division are trained on how to enter an Occurrence. A designated staff person in each work unit is trained to triage the Occurrences, re‐assign to a colleague in a different work unit for follow‐up and resolution, or resolve the occurrence themselves. The Service Now application has been configured to automatically generate charts and reports on a monthly, quarterly and annual basis. These reports are reviewed quarterly by the designated staff who triage and resolve occurrences to discuss trends and improvements.. Sample reports include an Excel spreadsheet containing all data elements for each Occurrence (by month, quarter or year) and frequency distribution charts by:  Occurrence site/responsible party  Product/Sample type  Occurrence/issue type Conclusion: Service Now is a flexible and user‐friendly software application customized by NMDP IT staff to allow for the easy entry, tracking and reporting of occurrences that do not qualify as a Quality Incident. Nearly 500 occurrences are reported per quarter, the majority of which are related to blood sample collection, labelling or shipping errors at the CT/IDM stage. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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By Occurrence Site – Q3 FY14
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Abstract 16 “Quality is Everybody’s Business”: Quality Oversight Structure at National Marrow Donor Program / Be The Match Authors: Bette Braem, Mayra Basiri Introduction NMDP’s quality oversight structure is set up to reach all levels of the organization, from the operational department level, to senior management, and ultimately to the executive leadership level. The goals of NMDP’s Quality Oversight Structure are to:  Integrate quality management practices into operational processes  Promote compliance with standards and regulations  Improve stakeholders’ involvement in quality initiatives  Facilitate process improvement  Escalate significant quality issues to appropriate leadership authority  Promote a quality culture at all organizational levels Methods At the department level, individuals are chosen to serve as Department Quality Representatives (DQRs). DQRs work in frequent collaboration with Quality and Regulatory staff to:  Report and investigate quality incidents  Coordinate corrective actions and preventive actions (CAPA)  Assist in communication and implementation of quality initiatives within their area At the senior management level, the Quality Leadership Team convenes quarterly and is responsible to:  Evaluate and prioritize organizational regulatory risks and appropriate actions to reduce risk  Ensure resources to support quality systems and regulatory compliance. At the highest leadership level, the Executive Team holds ultimate authority to make strategic decisions on high‐impact/high‐risk quality and regulatory issues. A report of the quality management system is shared with the Executives each quarter. In addition, quality and regulatory issues are reported twice per year to the Compliance Oversight Committee, which faces the NMDP Board of Directors. Conclusion At NMDP, quality practices and initiatives are not limited to staff with the quality and regulatory departments. NMDP’s quality oversight structure plays an important role in spreading the principles of quality management and regulatory compliance throughout the organization. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 17 Faster and safer – is it possible to optimize the transport process in matters of time and safety Authors: Sabine Schöffel‐Weiß, Karin Weber, Hans Müller, Sarah Sedlatschek, Markus Block As the period between the end of a stem cell collection and the arrival at the transplant center is absolutely decisive, we have peered the whole process with the aim to make the process faster and safer. Discussing this topic, the main focus lies on the time period until the product arrives at the TC as well as on the used transport materials. Therefore we have analyzed 240 transports within Germany, some selected European countries as well as some destinations outside Europe to find out how long the average time period is in each case. As safety is another keyword we have also taken a close look on different transport boxes and especially on the fact that in most of the cases cooling elements have to be changed during hand‐over. Concerning the time period it was astonishing that the transport duration can be reduced by an average of 72 % (~20 h) within Germany and of 61,5 % (~16 h) in selected European countries; even in some parts outside Europe a reduction of 32,5 % (~14 h) seems to be possible. In reference to the transport boxes the cooling elements are the main problem; as they often have to be changed during hand‐over many basic aspects can not be proofed such as age, storage duration and storage place. As long as these points can not sufficiently be proofed, the change represents an extreme lack of security. Both aspects lead to the conclusion that it is important to push on the process in cooperation with all involved partners to reduce the time period until arrival at TC; simultaneously couriers should either use a transport box where cooling elements don`t have to be changed or a control system has to be implemented to assure age, way of cooling and cooling duration of the panels. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 18 Effect of increasing of national donors’ pool in Poland on Polish patients and their chance for finding unrelated donor. Authors: Małgorzata Dudkiewicz, Anna Łęczycka, Klaudia Nestorowicz, Karolina Kosmala, Jarosław Czerwiński, Jolanta Żalikowska‐Hołoweńko, Roman Danielewicz In the last five years the number of registered potential hematopoietic stem cells donors in Poland increased more than four times, from about 146 000 to 680 000. The growth of the number of patients qualified to HSC transplantation from unrelated donor was not so spectacular: from 511 in 2010 to 631 in 2013. We observed a striking change in the percent of transplantations performed in Polish centres using material collected from national donors: from 24% (2010) to 54% (2013). This shift was also evident in the number of search procedures closed with acceptation of Polish donor: from 27% in 2010 to 55% in 2013. Another consequence of Polish registry growing is the increase of the donation number from Polish donors for international patients. Between 2010 and 2013 the percent of donation for non‐
national patient increased from 33% to almost 74% of all collections performed from Polish donors. That signifies the total inversion of proportions and places Poland on the 6th position in the ranking of the HSC exporters in the world. This is a meaningful change, but we tried to answer the question: did the increase of the database of Polish unrelated donors influence the situation of national patients with poor prognostic match results? To investigate this problem we compared the numbers of patients with 0 potentially matched donors in BMDW and in Poland in years 2010‐2014 and tried to statistically evaluate difference in proportions of patients with no potential donors over the years. We also try to compare empirical probability distributions for finding ABDR matched donors for Polish patients in the examined timespan. Performed analysis can help answer the question if there is a maximum number of transplantations which can be performed in the country using only national donors and which registry size is optimal. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 19 THE MOST common Greek HLA haplotypes in the Hellenic Cord Blood Bank inventory Authors: Amalia Dinou, Maria Spyropoulou‐Vlachou, Andreas Papassavas, Louiza Potamiti, Theofanis Chatzistamatiou, Efstathios Michalopoulos, Catherine Stavropoulos‐Giokas The ultimate purpose of the public cord blood banking is to establish an inventory with a large HLA diversity. It is, therefore, essential that in terms of histocompatibility, the stored CB units are representative of the population from which they derive as well as of ethnic minorities present in the population. The Hellenic Cord Blood Bank (HCBB) has an inventory of 2700 CBUs. Objectives: The aim of this study was to estimate the distribution of HLA‐A,‐B,‐DRB1 alleles and the A‐B‐DRB1 haplotype frequencies of the HCBB inventory. For this reason the phenotypic and allelic frequencies of 2413 CBUs donated exclusively by mothers of greek descent were obtained. Materials and Methods: The 2413 CBUs and their paired maternal samples were HLA‐A,‐B,‐DRB1 typed at the 2‐digit level, using PCR‐SSO (LIFECODES, Immucor) and the typing results were analyzed using Arlequin v3. Results: The most frequent allelic groups for HLA‐A were: HLA‐A*02 (27.7%), HLA‐A*24 (16.3%); HLA‐A*01 (10.4%); HLA‐
A*03 (8.7%), HLA‐A*11 (6.9%) and HLA‐A*32 (6.7%), whereas HLA‐A*36 and *43 were not represented. For HLA‐B the most common were HLA‐B*35 (16.1%); HLA‐B*51 (14.3%); HLA‐B*18 (12.7%); HLA‐B*44 (7.8%); HLA‐B*07 (4.4%) and HLA‐B*40 (4%) whereas HLA‐B*54,*59,*67,*78,*81,*82 and *83 were not represented. For HLA‐DRB1 the most frequent alleles were HLA‐DRB1*11 (27.9%), HLA‐DRB1*16 (13.8%) and HLA‐DRB1*13 (9%). There was no statistical difference among these allele frequencies and those previously reported concerning the Greek population. The most common haplotypes in this sample were A*02~B*18~DRB1*11 (3,4%); A*02~B*51~DRB1*11 (2.1%); A*01~B*08~DRB1*03 (1.9%); A*24~B*35~DRB1*11 (1.6%); A*24~B*18~DRB1*11 (1.5%); A*02~B*51~DRB1*16 (1.2%) and A*24~B*51~DRB1*11 (1.0%). Conclusions: In the future, an in depth and continuous analytical process of the CBUs haplotypes will ensure the dynamic evolution of the HCBB. Activities such as CB collection, planning or inventory renewal will be based on those results in order to achieve an optimal ethnic representation. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 20 A novel strategy for the development of the Hellenic Cord Blood Bank (HCBB)
Authors: Catherine Stavropoulos‐Giokas , Helen A. Papadaki , Alexandros Spyridonidis , Theofanis Chatzistamatiou , Efstathios Michalopoulos , Amalia Dinou , Vassiliki Gkiokas , Markos Sarris , Andreas Papassavas The aim of establishing a Public Cord Blood Bank, is to provide high quality CBUs, covering not only the most common HLA haplotypes but also rare ones, thus providing patients with a satisfactory probability of finding a suitable graft. In Greece, due to geographic reasons, a lot of the donated CBUs from islands or other isolated regions do not arrive in the condition required from the FACT/Netcord Standards as implemented by the Hellenic Cord Blood Bank (HCBB). For this reason, the HCBB has recently organized a decentralized system with the establishment of two “hubs” at the Hematology departments of the University Hospitals of Crete and Patras, where the CBUs collected in Crete and Western Greece will be received and sorted, and those meeting the HCBB quality criteria will be shipped to the HCBB Processing Facility in Athens under optimal conditions. This strategy will in the long term add to the inventory a number of high quality units, while enriching the inventory with unique haplotypes present in the populations of the regions covered. The results of the hubs’ operation so far are promising, although any effect in haplotypic content will not be evident immediately. This “hub” approach could be applied to a broader context, where neighboring countries with closely related populations as evidenced by HLA‐
based population studies, could develop a network of hubs where CBUs of different ethnic origins would be collected and redirected to a central facility. This would provide an alternative to the establishment of a CBB in every country as it would be financially more advantageous compared to the cost of creating and operating a fully accredited CBB. Such a network could be established between Balkan countries that do not have a public CBB covering their respective populations, giving them access to high quality, haplotypically diverse CBUs. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 21 From the Ground Up: Building a Comprehensive Incident Management System
Authors: Mayra Basiri, Tamara Lengacher, Bette Braem
BACKGROUND The NMDP Incident Management System (IMS) provides the framework for the detection, resolution and correction/prevention of events that do not conform to requirements. The IMS consists of documents (procedures, other) that outline related processes and requirements, and an FDA‐compliant software system (MasterControl™). The IMS includes two interrelated processes: Quality Incident (QI) and Corrective action/Preventive Action (CAPA). See process flowcharts. Prior to the implementation of the IMS April/2012, there was not a comprehensive system in place to document, manage, and resolve incidents that did not conform to requirements. The system was based on manual processes with many identified gaps and deficiencies. This represented high regulatory and liability risks to the organization. Driven by changes in the regulatory climate and a desire for process improvement, NMDP determined that a comprehensive IMS was needed to support the organization. METHOD/RESULTS The Quality Systems department (QA team) was tasked with developing and implementing an electronic IMS that meets organizational and regulatory needs. MasterControl™ was selected as the IMS software. A team of stakeholders was formed to provide feedback and help define incident criteria. The IMS was built “from the ground up”, including:  QI criteria defined  Processes (QI and CAPA) designed and timelines established  Requirements identified  MasterControl™ QI and CAPA forms configured/validated  Risk‐based tool established to assess CAPA needs  Multiple procedures created  Training created and delivered  Incident codes created for tracking/trending  Reports created  Department Quality Representative role created to investigate incidents  The IMS was implemented in two phases: October/2011 for cord blood ‐related QIs, and April/2012 for adult products and other QIs. CONCLUSION Although it took a significant effort to design and implement, the IMS is now a comprehensive system that supports regulatory compliance, process improvement, and a quality culture at the NMDP. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 22 Divide and Conquer: Documents Managed Two Ways to Meet Regulatory and Organizational Needs Authors: Mayra Basiri, Jody McNaughton, Bette Braem
Background: The NMDP Document Management System (DMS) provides the framework for document development, approval, storage, and version control. It is an essential component of quality management, with the goals of ensuring product quality, patient/donor safety, and regulatory compliance. The NMDP DMS consists of policies, procedures, forms, templates and aids that outline requirements and describe document management processes, and a FDA‐compliant software system (MasterControl™) to automate document control activities. NMDP documents require different levels of control and oversight based on applicable regulatory requirements. In early 2012, the QA‐Quality Systems department determined the DMS was not effective as evident by user complaints, help requests, and inconsistent/poorly written documents. Investigation Methods/Findings: A cross‐functional team of stakeholders formed to investigate and resolve the problem. Brainstorming and fishbone methods were used in the cause analysis. People, environment, method and equipment elements were analyzed. The following gaps and/or deficiencies were identified:  Process, requirements, and roles were not clearly defined  Process too rigid; all documents subjected to same controls regardless of regulations  Limited number of proficient users and resources dedicated to document management Solutions/Results: The DMS was re‐designed and implemented August 2013. Changes were made to streamline the process and address gaps and/or deficiencies.  Multiple procedures and support documents created to clearly define process  Documents classified into two separate categories (controlled and non‐controlled),  Departments designated staff to specific DMS roles, technical writer was hired  Role‐specific training developed and delivered There was no baseline data to compare the DMS before and after. However, QA feedback indicates that user complaints/requests for assistance decreased and the overall quality of documents improved. The DMS is now a comprehensive system and users have a greater understanding of requirements. The system allows for flexibility in managing documents with different levels of control and oversight needs. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 23 NMDP’s Collaborative Approach to ISBT Implementation
Authors: Mayra Basiri, Sallie Allman, Bette Braem
BACKGROUND ISBT 128 is the global standard for the terminology, identification, coding and labeling of medical products of human origin. It has been designed to ensure the highest levels of accuracy, safety and efficiency. A growing consensus of world leaders in cellular therapy are driving toward required adoption of ISBT 128. Current practices for labeling NMDP’s products: do not include a “globally” unique donation identifier, are inconsistent throughout the NMDP network, and rely on handwritten label data entry. The solution is to move NMDP and its network from handwritten to electronic label generation that includes a unique donation identification number and utilizes internationally‐accepted standard terminology and bar coding technology. METHOD/RESULTS Early 2012, NMDP formed a team to develop a plan to implement ISBT 128 throughout its network of collection centers. The plan includes the following products collected in the US: HPC, Apheresis; Concurrent Plasma, Apheresis; MNC, Apheresis; and HPC, Marrow. NMDP’s approach to ISBT 128 implementation is: simple, collaborative, and multi‐phased. For a description of each phase see table. A simple ISBT labeling system (standalone software, thermal printer, scanner) was selected. An implementation package was developed with the necessary resources to assist NMDP collection centers. The package includes: implementation plan template, financial compensation for software/equipment, validation plans templates, labeling procedures, and training modules. The implementation of ISBT 128 will be staggered throughout the NMDP network. 26 centers are currently collaborating with the NMDP; most have successfully completed validation and are planning to implement ISBT 128 this year. CONCLUSION It takes an enormous effort to implement ISBT 128 by an individual center on an independent basis. A team approach allows for collaboration between NMDP and network centers plus sharing of knowledge and resources. This results in greater efficiency in planning and implementation for all. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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ISBT 128 Implementation:
A Multi-Phased Plan
Year
Phase
2011
Preliminary Project Team (learning phase- ISBT 128
requirements and standards)
2012
Phase 1: Analysis (impact, strategy) and Scope
2013
Phase 2: Planning, requirements identification, vendor
qualification, needs assessment, and agreements with
vendor and subset of collection sites (pilot sites)
2014
Phase 3: Development of resources (procedures, validation,
training, other), and first wave of full implementation with
pilot sites
2015
Phase 4: Continue implementation throughout network
1
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Abstract 24 Rates of Bankable Cord Blood Units from different Collection Sites: Geography, Ethnicity or Experience? Authors: Marcie Finney, Kathy Bobik‐Kurz, Pamela Benson, Candice Laster, Faith DeDino, Kara Meyer, Phil Paul, PhD, Mary J. Laughlin, MD Background: Despite utilizing the same collection, shipping and processing procedures, there is variance in the rates of bankable cord blood units from our various collection sites. Factors that may contribute to these differences could be the distance from our processing facility, the ethnic diversity of the donors or the experience the site has with public banking. Materials and Methods: We analyzed public cord blood collections from 4 collection sites over a 12 month period. All cord blood collections were done in utero, weighed and assessed for pre‐processing total nucleated cell count. The collection sites are located in Ohio and Georgia. Cord blood units had to weigh over 85g of cord blood in order to proceed to evaluation. Processing must occur within 48 hours of collection. Ethnicity was based upon birthing center statistics provided by the collection sites. Results: Collection
%
Miles from % Collected African
Site
Processed
CCBC
> 48hrs American
A
29%
8
3%
19%
B
30%
21
2%
7%
C
22%
705
7%
17%
D
18%
705
3%
77%
Asian
6%
3%
5%
2%
Caucasian
73%
82%
69%
17%
Years
Banking
6.2
5.7
1.4
1.1
Conclusion: The 4 collection sites evaluated had varied processing rates with a range of 30%‐18%. The two highest processing rates were the collection sites that are geographically close and have the most experience. Although the collection site with the highest amount of ethnic diversity has the lowest processing rate, this site also has the least experience. Further analysis is needed to determine the processing rates by ethnic group. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 25 Key Driver Analysis of HLA Diversity: Analytically focused recruitment strategies for improving registry quality Authors: Adarsh Sivasankaran, Eric Williams, Mark Albrecht
Multiple copies of the same HLA type in the Be The Match registry can be beneficial to an extent, especially with regard to overcoming availability and typing ambiguity issues. However, maintaining a registry where greater than 50% of donors have a copy count between 4 and 10,000 represents waste in the form of donors that are unlikely to be utilized. To eliminate waste and improve registry quality, we performed a key‐driver analysis of HLA diversity to inform efficient recruitment practices. We estimate a HLA copy count for each donor in the registry from imputation data. A HLA type is rare if less than 4 copies are in the registry (approximately 50% of the registry). We trained a boosted CART (Classification And Regression Trees) model to identify factors associated with rare HLA. This analysis was performed on a set of donor demographic and geographic characteristics. In the model, 18 variables had a positive contribution to the HLA rarity prediction from a set of 200 variables. Of these, variables with highest influence were found to be Rollup Race, Designated Market Area (DMA), associated Tapestry® Segment, and Donor Centers, in decreasing order of magnitude. As an example, the model identified donors in the top DMA (Yuma, AZ‐ El Centro, CA) to contain 156% more rare HLA types versus the bottom DMA (Glendive, MT). Further, the CART modeling approach accounts for interactions between multiple variables where the influence of donor race on HLA type, for example, is dependent on geographic location. Such modeling features predict 180% more rare HLA type recruitment as compared to naïve recruitment. Application of analytically focused recruitment strategies appears to have the potential to increase registry diversity. Delivery of this information through interactive data‐products was shown to be feasible and expands accessibility of these concepts to a non‐technical audience. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 26 Enhancing HML for Electronic Reporting of NGS‐based HLA and KIR Genotyping Result
Authors: Kathryn J. Doroschak, Robert P. Milius, Joel Schneider, Michael Heuer, Michael George, Jane Pollack, Seonghan Kim, Nezih Cereb, Jill A. Hollenbach, Steven J. Mack, Martin Maiers We present an electronic format for exchanging data for HLA and KIR genotyping, with extensions to next‐
generation sequencing (NGS). This format addresses NGS data exchange by refining the Histo‐immunogenetics Markup Language (HML) to conform to the proposed Minimum Information for Reporting Immunogenomic NGS Genotyping (MIRING) reporting guidelines (ngs.immunogenomics.org<http://ngs.immunogenomics.org>). The development of the revised HML standard was led by the National Marrow Donor Program through a series of meetings and discussions with the HLA Information Exchange Data Format Standards Group, as well as the Immunogenomic NGS Data Consortium, a community of registries, clinical and research laboratories, and industry partners focused on identifying and addressing specific data‐reporting requirements for NGS‐based genotyping. MIRING constitutes a set of guiding principles and best practices for reporting an NGS genotyping result specific to HLA and KIR. Our refinements of HML address MIRING requirements via two major modernizing additions. First and foremost, NGS is supported by new XML structures to capture all NGS data and metadata required to produce a genotyping result, including analysis‐dependent (dynamic) and method‐dependent (static) components. A full genotype, consensus sequence, and the surrounding metadata are included directly, while the raw sequence reads and platform documentation are externally referenced. Second, genotype ambiguity is fully represented by integrating Genotype List Strings, which use a hierarchical set of delimiters (/, ?, +, |, and ^) to represent allele and genotype ambiguity in a complete and accurate fashion. HML also continues to enable the transmission of legacy methods [e.g. site‐specific oligonucleotide, sequence‐specific priming, and Sanger Sequence Based Typing (SBT)], adding features such as allowing multiple group‐specific sequencing primers, and fully leveraging techniques that combine multiple methods to obtain a single result, such as SBT integrated with NGS. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 27 Networking policies of emerging registries – Greek Registry CBMDP (GR2)
Authors: Alexandra Sarma, Georgia Oikonomopoulou, Eugenia Kefala, Alexandros Spyridonidis As a young registry established in 2010, the Centre of Bone Marrow Donor volunteers ‐ University of Patras (CBMDP) faces the challenge of rapidly creating a large national pool, with minimum resources. To achieve this, CBMDP chose to apply a robust networking policy by investing in the establishment of a vast nationwide network of 40+ collaborating parties (blood banks, blood/cancer/transplant related NGOs etc.). The aim is to outsource the recruitment process to partners, allowing the Centre to focus on network supervision, fundraising, donor management and QA policies. CBMDP engages partners with presence in multiple towns and a committed following by local populations (future committed donors). All partners are specially trained following SOPs and equipped with all materials necessary (swabs, applications, courier service etc.). The Centre ensures the support of partners as it: a) Selects organizations with similar objectives, b) clearly transmits its goals and plans to meet them, c) offers acknowledgement letters, d) sends framed commendations signed by high profile individuals, e) includes partner names on its website and highlights them in different colors, according to number of recruited donors, f) refers to their contribution in conferences, seminars etc. CBMDP Partner Network Impact: 1. With minimum cost, a nationwide network was rapidly set up. 2. Donor recruitment rate increased after the first two years. 3. The Centre was able to “hijack” and capitalize on the social media outreach of its partners. 4. The Centre’s initiative was received as a well‐organized nationwide effort rather than a local endeavor (benefiting both recruitment and fundraising). 5. Donors had significant geographic distribution (benefiting HLA diversity). 6. Uniform practices and standardized procedures were applied, common IT infrastructures introduced and adherence to legal/ethical norms was assured, on all partners already recruiting donors. Future goals: Expand the network in Northern Greece, optimize connection within network parties. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 28 A record of the 20 years history for unrelated volunteer donor recruitment and transplant activities in
Catholic Hematopoietic Stem Cell Bank (CHSCB) Authors: Ok‐Ja Hyoung , Su‐Hee Beom min‐jung , Kwak, Tai‐Gyu Kim
Background: In 1983, The first allogeneic bone marrow transplantation was performed at
Hematopoietic Stem Cell Transplantation Center, The Catholic University of Korea. After the first
operation, the university decided to open the dedicated medical center for unrelated volunteer
donor recruitment and transplant activities and CHSCB was established in 1994. CHSCB is a
non-profit organization to recruit volunteer donors and coordinate hematopoietic stem cell
transplantation between unrelated donors and recipients.
Since CHSCB established, CHSCB has recruited 48,565 volunteer donors and facilitated up to
1078 transplants in Korea. This outstanding result comes from the devoted efforts of all team
members of recruitment, coordination, HLA laboratory, cord blood bank and Immune Genes&
therapy of CHSCB. In addition, CHSCV successfully operated 25 transplantations with
international cooperative registries with extensive network with 44 transplant centers, 42 bone
marrow collection centers, apheresis centers, and cooperative international centers abroad.
An activities for unrelated volunteer donor recruitment and transplant activities in CHSCB during
the last two decades are summarized in this presentation. It includes the statistical data of the
distribution of volunteer donors, donor agreement rate, and the distribution of stem cell source in
unrelated stem cell transplantation. On top of the summary of the activities, we’d like to
emphasize the unique coordinate structure and trends in donor coordination system in Korea.
Study design: analyze the process of volunteer donors’ recruitment and the trend of unrelated
stem cell transplantation in KOREA over the last 20 years.
Donor recruitment and transplant activities:
The structure in Korea consists of KONOS, as a Registry and 2 donor centers (CHSCB, KMDP).
In 2006, KONOS started to use donor data for unrelated hematopoietic stem cell transplantation
as a registry. From 1994 to 2013, 265,307 registrants have been registered in the KONOS and
18% of the registration was done through CHSCB –male 77%, female 23%.
Donor agreement rate for the stem cell donation is 56.3% and the dominant reason for the
rejection is refusal of the family member, which takes 34.9% of the rejection. The change of
registrant mind takes and the change of health condition take 28.3% and 25% respectively.
Over the past 20 years, 4,442 cases of HSC transplantation were performed in Korea, types of
transplantation performed are autologous(44.5%), related mismatched (9.6%), related identical
(21%), unrelated donor matched ( 23%), and cord blood (1.9%).
Among 4,442 cases of HSC transplantation 1078 cases 24.3% were done using hematopoietic
stem cell donated by the CHSCB. The distribution of stem cell source is bone marrow
transplantation 26.5% and peripheral blood stem cell harvesting (PBSC) methods 73.5%.
The distribution of disease entities being transplanted in allogeneic settings is acute myeloid
leukemia (AML) (24.2%), acute lymphoblastic leukemia(ALL) (12.7%), chronic myeloid leukemia
(CML) (1%), myelodysplastic syndrome (MDS) (6.4%), aplastic anemia (AA) (6.1%), Multiple
myeloid (MM) (18.2%), non-Hodgkin's lymphoma (NHL) (18.4%), and other diseases (13%).
Conclusion:
During the last two decades, CHSCB has achieved outstanding results in transplantation area.
But we think it is still necessary to study more how increase donor agreement rate and matching
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rate, management after recruiting, the coordination of appropriate stem cell collection and analysis
clinical data for minimize GVHD to give suitable unrelated stem cell transplantation for patients.
We are willing to continue to study and analyze clinical outcomes to expand patient’s transplant
opportunities and to make best choice of graft source (HLA-matched sibling donor, unrelated,
haploidentical, or umbilical cord blood).
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Abstract 29 A practical guide to enhance process reliability at work‐up
Authors: Claudia Benkoe1, Vanessa Brandner1, Judith Maeck, Ingrid Tistl1, Hans‐Peter Eberhard1 All organizations involved in the work‐up process have the same goals: The safety of the donor and recipient and 100 percent process reliability. The work‐up process is integrated into the Zentrales Knochenmarkspender‐Register für die Bundesrepublik Deutschland`s (ZKRD) ISO certified quality management system as a major process. Although the process has a defined structure, the ZKRD identified a need for cooperative transplant centers to gain more detailed knowledge of the procedures at the Registry in order to improve communication and understanding regarding required documents, individual steps, and related time frames. The first Transplant Coordinators’ Workshop in 2013 was intended not only to serve as training for new coordinators, but also offered the possibility of exchanging information, thus allowing for process improvement. The aim is to establish a practical guide supporting procedures already in place for a safe, effective and cost‐efficient process and also ensure the quality of the medical practices. This is only possible when all organizations involved cooperate with one another in a structured process, while allowing for flexibility and resourcefulness of coordinators in order to recognize critical situations early on in order to compensate for acutely occurring problems quickly and responsibly. As a result of the Coordinators’ Workshop, a manual for German transplant centers, donor centers and collection centers is under preparation. Colleagues representing cooperative partners collaborated with the ZKRD in its development. The goal of this manual is two‐fold:  To reinforce standardized procedures at and between individual centers  To improve the transparency of the work‐up process in general The manual includes helpful information concerning the general coordination of work‐ups, necessary documents, some international requirements, applicable regulatory guidelines and practical checklists. We would like to share our first results with the international community in order to initiate an exchange of ideas, identify needs for harmonization and evaluate opportunities for improved international collaboration. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 30 Analyzing and optimizing workup procedures to improve international collaboration Authors: Arnim Kathke, Dunja Reichart, Hans‐Peter Eberhard Carlheinz Mueller Although the donor search process benefits from extensive computer support (EMDIS, BMDW) the final critical stage of donor work‐up and transplant coordination (comprehensively called WU) still is largely a manual process. In order to quantify the workload, to identify major structural or organizational obstacles and to optimize the internal procedures and the interaction with the partners, the ZKRD work‐
up team has started an internal analysis and review process. Here we report the results of the time requirement analysis performed in this context. Work‐up requests were classified as all national, international donor and international patient. Moreover, they were put in to three separate categories of difficulty according to the previous experience of the partners involved on the donor and patient side (availability, responsiveness, center‐ or country‐specific features). Over 60% of all WU requests received by ZKRD for fully managed coordination between August and December 2013 entered the analysis. For each WU, the time spent by the ZKRD coordinator in five mostly consecutive steps from registration of the request to the recording of the collection report was noted. Statistical methods include basic descriptive approaches within the groups (mean, five number summary, outliers), multivariable analysis using the above mentioned predictors. Moreover, we compared the donor unavailability rate at work‐up to the figures in the WMDA annual report. WUs with an international donor or patient require more than twice the time of national WUs. Within each class, the easy WU require one third less time than the reference group whereas difficult ones require 25%‐50% more time. In our cohort of about 260 ZKRD‐coordinated WUs for German donors, we observed a donor unavailability rate of approx. 5% which meets the WMDA KPI target value. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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On this basis we intend to propose several measures to optimize our internal procedures and to streamline international collaboration. 20141106‐EDUC‐All abstracts Edu day EDUC
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Abstract 31 Ethical and other issues in a changing CT world
Authors: Annette Rasche, Jennifer Wüstefeld. Andrea Timm, Ulrike Beth, Hans‐Peter Eberhard Verification typing has irreplaceable means for securing the HLA identity in donor/patient matching. The development from serologically‐only typed donors to standard 5‐6 loci NGS typing of donors and patients is changing the search process tremendously. The matching probability between donor and patient becomes more and more obvious from the first search report. This is also reflected in the significant decline of DRB1 typing requests in recent years. It has been positively remarked that options to shorten the search process have thus been created allowing serving patients in a timelier manner. However, despite the high number of new donors and easier means of donor recruitment due to online platforms and social media, paradoxically the percentage of donor non‐availability has remarkably risen, hereby leading to a trend to request more CTs in parallel to avoid last‐minute drop‐outs. The increasing number of donors induces to strong competition between donor centres where more enterprising donor marketing tools are moving in, such as marking donors with immediate availability or the creation of “Premium Donors”. There is a trend to skip the entire search process and to request donors directly for workup. The necessary verification typing is performed from pre‐collection samples, thereby not leaving sufficient time to psychological donor preparation. Furthermore, the verification of typing and matching errors with regards to donor HLA might be detected in a very late stadium of the process only. These aspects need to be carefully analysed and incorporated into future international regulations in order to assure the continuous high quality of the search process and corresponding patients´ outcome and the welfare of donors. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 32 Implementation of a new transport container as a quality measure
Authors: Judith Maeck, Vanessa Brandner, Annette Rasche
In view of serious adverse events and reports received regarding difficulties with transports, there was an increased demand in recent years for the ZKRD to search for a new transport system. The new container met strict quality requirements, was especially qualified for use when transporting HPC products, demonstrated easy handling and employed a system preventing the use of unsuitable cooling elements. The transport container selected is vacuum‐insulated with superior thermal protection to ensure that products can be stored at the correct constant temperature for up to 96h. Its design includes specific thermally‐insulated walls with integrated phase‐change material, maintaining product storage at 4° to 8°C regardless of the environment. Based on German Standards and WMDA recommendations, the ZKRD developed a comprehensive validation protocol for the transport system. Validation included testing at extended transit times while exposing the box to the expected and to deviating external temperatures. Consequences of a potential deviation from the user guide were also included in the validation. Upon completion of validation we released the transport box for use by national transplant centers and commercial couriers. The ZKRD will equip all national transplant centres with the new box. All German collection centres will also be equipped with some TIC cooling panels as back‐ups for couriers, however a major criteria was this system’s prolonged temperature control, which limits the necessity for exchanging panels at pick‐up. The container is labelled according to international standards and uses the corporate design of the ZKRD. Additional transport boxes can be ordered by all German partners via the ZKRD. By validating the system, providing identical boxes and matching panels to national partners and introducing a box with a ZKRD identifier, we hope to reduce transport incidents by improving handling while increasing awareness for these transports among security and customs officers. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 33 What is the optimal number of donors in a registry?
Authors: Carlheinz Müller, Annette Rasche and Hans‐Peter Eberhard
This seems to be one of the most frequently asked questions in the world of donor registries. It typically occurs in the creation phase of a registry or during grant applications when targets should be underpinned with a good rationale. Strangely enough, registries approaching a more substantial size tend to stop asking this question. A scientifically sound analysis of this issue requires a rigorous definition of the term “optimal”, e.g. by specifying the underlying function for which a maximum (or minimum) is to be sought depending on certain parameters. Albeit not easy, the monetary cost side of this function – recruiting new donor, operating a registry and performing searches – can be seriously calculated. The technically, ethically and politically difficult part however is to quantify the benefit, i. e. to assign a monetary value to the quality adjusted additional life years (QALY) gained by this expensive, high‐tech therapy. Finally, quantifying important medical and socio‐psychological effects (e. g. compassion, hope, and care minus the burden put on donors) is virtually impossible. Moreover, the situation becomes even more complex since in many regions there are several competing registries and a substantial fraction of the patients has a choice of many donor candidates at any stage of the search including the final transplant. Based on quantitative aspects of population genetics, our analysis will offer different ways to define “optimal” in this context and show the dependence of the optimal number of donors from the price of the recruitment, typing and retention of donors, the price and success rate of transplants, the size of the patient population and similar parameters. Although there apparently is no simple and generally conclusive answer to the title question we will show a rational approach. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 34 Automated monitoring and reporting of CT‐discrepancies
Authors: Ulrike Beth, Anja Siebinger, Petra Russ, Anne‐Lise Péco, Andrea Timm, Werner Bochtler and Carlheinz Müller WMDA’s annual „CT Discrepancy Survey“ is one of WMDA’s most important global quality assurance endeavours. In order to correctly reflect the pre‐CT data, a new and more sophisticated data reporting system was developed. Unfortunately, it is laborious to correctly assign the discrepancies occurring in almost 20,000 CTs annually into so many categories in a mostly manual process. Therefore, ZKRD developed a system to detect and classify CT discrepancies, to guide the operator through a clarification process with minimal data input and to document the outcome up to the final reporting to WMDA. Every Sunday, all CT results newly arrived from the TC labs during this week are compared with the donor’s HLA type as it was known at the time of the request. The HLA is extensively validated for correct and current coding and consistency between serological and DNA assignments. The subsequent comparison only flags differences in the amino acid sequence of the antigen recognition site and gives an additional special treatment to unexpressed alleles. For any relevant discrepancies the corresponding request and the affected loci are recorded into two database tables where the further clarification is also documented. If the TC lab/patient registry did not explicitly refer to the discrepancy it is contacted first to exclude errors there. Then the DC/donor registry is contacted and asked for clarification, possibly leading to a re‐typing of the donor. All communication to the patient and donor side is performed via automatically generated faxes or emails and the responses are recorded by a coordinator at ZKRD with just a few mouse clicks. Although implementing the complicated HLA logic of this system was quite straight‐forward using pre‐
existing building blocks (esp. the HLAcore library), extensive work had to be put into the design of detailed logics and logistics for this highly individual process. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 35 OptiMaS – OptiMatch® as Service Authors: Werner Bochtler, Markus Beth, Andreas Mack, Andreas Vogt, Hans‐Georg Rist and Carlheinz Müller In late 2006 ZKRD introduced its OptiMatch® search engine for the matching of volunteer unrelated stem cell donors to patients in need. The underlying algorithms reflect the complexities of HLA, indicate the likelihood of potential donors to turn out as matches after future testing and can be tailored with options and filters to any special needs. Since in a powerful matching system the software and the database are tightly interwoven, transplanting OptiMatch into another registry’s business software did not seem feasible. So the ZKRD’s IT team isolated the core parts of OptiMatch® into a deployable stand alone system. OptiMaS (“OptiMatch® as Service”) is a “black box” computer giving access to the capabilities of OptiMatch® via a small set of high level web service functions. These can be divided into three categories: data maintenance, retrieval of search reports and administrative tasks. OptiMaS fully supports the EMDIS matching preferences and is compliant with the WMDA HLA Nomenclature Guidelines. The OptiMaS “match box” consists of a 64‐bit Linux server running a PostgreSQL database. The programs included are built on ZKRD's programming libraries HLAcore (HLA nomenclature) and HLAmatch (matching logic). The numerous, fully automated tasks include the daily update of the NMDP allele code definitions, the backup of the database and the update of the matching results for the current patients. The SOAP web service layer of OptiMaS is implemented in C# running on the .NET compatible Mono framework. OptiMaS has been used in a production environment at the Canadian OneMatch registry since March 2012 and at the Australian Bone Marrow Donor Registry since fall 2013. From the beginning, OptiMaS has been running reliably and has meanwhile demonstrated to be a sound option for registries to benefit from the advantages of the OptiMatch® search engine locally. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 36 Another NGS: The New GerMIS System consisting of BMDnet and BMDauto
Authors: Markus Beth, Werner Bochtler, Florian Scheel, Daniel Freund, Hans‐Georg Rist und Carlheinz Müller GerMIS, the German Marrow Donor Information System, has been the German national communication system for unrelated stem cell donor search since the late 1990ies. Its name and some technical features have been inspired by EMDIS and, conversely, GerMIS technology was fed back into the European system. Unfortunately, the classical GerMIS design with local databases communicating with the central hub through encrypted emails could not unleash the full power of the new matching technology OptiMatch® to the users in the search units. As a consequence, the web‐based user front end BMDnet was designed and implemented providing real‐time access to ZKRD’s search system. BMDnet makes the flexibility of the searching and filtering options of OptiMatch® directly available to the search units. Since a local database and EMDIS‐like communication interface was no longer available at the centres, a new approach for the interfacing of local computer systems was required. We therefore complemented the human user interface BMDnet with a machine interface called BMDauto allowing the computer system of a each search unit or TC lab to directly interact with the ZKRD back‐end through SOAP web service calls. The activities covered so far are the submission of patient’s confirmatory typing, donor CT results including the validation and comparison of the HLA data provided and the retrieval of a list of open CT requests. The integrity and confidentiality of the communication between client and server is ensured through WS‐Security and the mutual authentication is based on X.509 certificates. BMDnet and BMDauto have grown into a fully fledged and much more powerful replacement for our old GerMIS search unit software SeCCom. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 37 Optimization of donor selection: a retrospective analysis of OneMatch HSC transplants recipients (2013)
Authors: V. Greco‐Stewart, D. Killeen, S. Haun, D. Mercer
Canadian transplant centres are ultimately responsible for donor selection for allogeneic HSC transplant. OneMatch search analysts provide initial BMDW and registry searches and use their HLA expertise to guide donor selection. The goal of the present study was to determine if the most appropriate donors were chosen for HSC recipients transplanted in 2013 and if OneMatch donors were being utilized when appropriate. The “optimal donor” assessment was based on HLA match level between donor/recipient pairs at HLA‐
A,B,C,DRB1,DQB1 using the donor pool available at the time of patient search initiation. If a potential donor was overlooked, additional criteria such as donor age, gender, and availability were investigated. For patients who received a 10/10 match, OneMatch donors were routinely employed when a young, male donor was available. Almost half of patients receiving HSC from 10/10‐matched international donors did not have an optimal match in our registry. Almost 20% of these patients were non‐Caucasian and donors came from registries enriched for donors of similar ethnic backgrounds. However, almost 30% of patients had high‐probability 10/10‐matched OneMatch donors. In these cases, Canadian donors were frequently investigated; however there were instances in which suitable Canadian donors were overlooked. When a 9/10 match was chosen, potential 10/10‐matched donors were investigated where appropriate and permissive mismatches were chosen when possible. CBU transplantation was typically employed when suitable donors were not available; donors were investigated for all adult 80% of paediatric CBU recipients; in the latter circumstance donors were very limited. This study has shown that our patients have been receiving suitable HLA‐matched donors and that OneMatch donors have typically been used where appropriate. Increased support to transplant centres through formal search analyst patient assessments, implementation of haplotype‐based match‐level prediction algorithms for OneMatch donors, and educational resources will help to ensure that optimally‐matched donors are consistently chosen for investigation and that use of OneMatch registrants is optimized. 20141106‐EDUC‐All abstracts Edu day Abstracts Education Day
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Abstract 38 The long‐term effect of short course G‐CSF stimulation on PBSC donor blood parameters: A OneMatch follow‐up study Authors: Volesky K, Yi Q‐L, Greco‐Stewart V, Haun S, Dufresne A, & Goldman M
In some clinical settings, granulocyte‐colony stimulating factor (G‐CSF) has been associated with the development of haemotogical malignancies. Data collected from peripheral blood stem cell (PBSC) donors to date has been insufficient to exclude this risk in the long‐term. To assess the possible long‐term effects of short course G‐CSF (Filgrastim, 4‐5 daily injections), OneMatch PBSC donors provided a complete differential blood test annually post‐G‐CSF administration. Annual age‐adjusted medians were calculated, and donors’ pre‐ and post‐G‐CSF administration blood parameters were compared. Mixed model analyses were performed to determine if the differences between donors’ pre‐ versus post‐G‐CSF administration results were statistically‐significant at p<=0.05. No statistically‐significant differences in red blood cell, hemoglobin, hematocrit, and differentiated white cell counts were observed between pre‐ and post‐G‐CSF administration parameters. There were statistically‐significant differences in donors’ pre‐ versus post‐G‐
CSF mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, and mean platelet volume (not shown). Median white blood cells (WBC) and platelets counts had a statistically‐significant decrease post‐G‐CSF administration (Figure 1). Although there were slight but persistent differences in certain post‐G‐CSF parameters, they were not clinically significant. An examination of 255 OneMatch PBSC donors did not reveal an association between short‐course G‐CSF and the development of haematological abnormalities, but based on study limitations an association cannot be excluded at this time. Figure 1: Age‐adjusted bi‐annual medians for select PBSC blood parameters Parameter WBC PLT x10 9/L Pre G‐CSF
n=255 Year 1 n=193 Year 3 n=101 Year 5 n=49 Year 7+ n=27 Min Median Max Min Median Max 3.1
6.3
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12.3
138.2
237.5
385.0
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8.7
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Abstract 39 OneMatch: Stem Cells National Systems Solutions Authors: Yves Garcia, Jennifer Skinkle The Stem Cells National Systems Solution is an SAP, integrated IT solution that is now being used to search and manage the selection of stem cell products through the OneMatch Stem Cell and Marrow Network. With this new solution we have made the following enhancements:  Seamless online registration process for those wishing to join the registry  Improvements to the search process by integrating to our partner’s (ZKRD) search and matching engine  Integrated Registry and Cord Blood Bank Supply Chain activities  Integration to our enterprise wide services such as Financial, Procurement, Logistics, Sales and Distribution to ensure accurate and timely billing/payments  Two‐way communication with other international registries to expedite Canadian patient searches (through the EMDIS communications protocol)  Authorized access for Canadian Transplant and Collection Centres to interact in realtime to request patient searches, make activation requests, and gain online access to search reports and donor/patient information.  Improvement of staff workflow tasks. The SCNSS system went live on July 2, 2014, and deployment to Transplant Centres and Collection centres will be completed by October 30, 2014. 20141106‐EDUC‐All abstracts Edu day