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Nurses' reported training needs for advanced cell therapies: a survey on behalf of the Nurses Group of the EBMT.

BackgroundAdvanced Therapy Medicinal Products (ATMPs) for human use have advanced globally with the rapid adoption of Chimeric Antigen Receptor T-cell (CAR-T) therapies in haemato-oncology. CAR-T cell therapy and ATMPs have unique, significant acute and chronic toxicities, and appropriate patient care is crucial. Significant challenges, including the need for nurse education and training, accompany optimal patient success and benefits.ObjectivesThis study aimed to describe nurses' training needs in relation to ATMP management and patient care.MethodsA cross-sectional online survey was performe

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… The majority of respondents worked in JACIE accredited (n=78, 72%), and academic centers (n=95, 87%), with adult patients (n=66, 61%). … Demographics ATMPs – Advanced Therapy Medicinal Products; BMT – Bone Marrow Transplant; JACIE - Joint Accreditation Committee of the International Society for Cell and Gene Therapy and the European Group for Blood and Marrow Transplantation | N Missing | N = 109 JACIE accredited | 0 | No | | 11 (10% …

The 48th Annual Meeting of the European Society for Blood and Marrow Transplantation: Nurses Group - Poster Sessions (NP001 - NP054).

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… JACIE's accreditation and Swissmedic's authorization were performed in parallel. … However, the HKs do not receive formal training in Infection prevention and control that underpin quality measures of JACIE accreditation and standards. …

Determinants of Outcomes for Acute Myeloid Leukemia Patients Treated in a Community-Based Specialized Versus Non-Specialized Hospital Setting.

The treatment setting influences acute myeloid leukemia (AML) outcomes. Most cancer patients receive care in the community, yet few studies have evaluated the effectiveness of clinical programs outside of academic or National Cancer Institute (NCI)-designated cancer centers. This was a multi-level, case-controlled study of real-world outcomes for initial AML treatment in a community-based network for 1,391 patients with AML between 2011 and 2018. We benchmarked survival within our network against the Surveillance, Epidemiology, and End Results (SEER) database. Coarsened exact matching was perf

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… All SCBCN centers are in large hospitals, treat high volumes of AML patients, and are CoC accredited, resulting in little to no variability within the SCBCN grouping. … Due to the high multicollinearity between facility bed count, AML treatment volume, and CoC accreditation, these variables were removed from the analysis. …

Advancing access to CAR T-cell therapy: insights and real-world experience from a community oncology practice.

IntroductionChimeric antigen receptor (CAR) T-cell therapy has transformed the treatment of hematologic malignancies, offering durable remissions for patients with otherwise refractory disease. However, access to these therapies remains limited and primarily restricted to academic medical centers, contributing to significant geographic and demographic disparities in care delivery.MethodsWe conducted a retrospective review of a community practice-based outpatient CAR T-cell therapy program, independent of academic or hospital affiliation, treating patients with relapsed hematologic malignancies

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… Methods The outpatient CAR T-cell therapy program was developed leveraging the practice’s existing Foundation for the Accreditation of Cellular Therapy (FACT)-accredited autologous stem cell transplantation infrastructure and quality systems. … While FACT accreditation may not be necessary to safely deliver CAR T-cell therapy, third-party payers are increasingly incorporating accreditation status into provider network criteria and coverage determinations. …

A regional analysis of payer and provider views on cholesterol management: PCSK9 inhibitors as an illustrative alignment model.

BACKGROUND: Multiple barriers exist for appropriate use of the proprotein convertase subtilisin/kexin type 9 enzyme inhibitors (PCSK9i) in p … College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications ( …

Exploring Affordable Curative Therapy for Sickle Cell Disease in Africa: A Comprehensive Overview.

The practical aspects of developing curative treatments for sickle cell disease (SCD) in Africa, such as gene therapy and hematopoietic stem cell transplantation, involve strengthening healthcare infrastructure, training healthcare professionals, establishing regional treatment centers, and creating national SCD programs. The costs associated with gene therapy and stem cell transplants can be prohibitive, especially in low- and middle-income countries. Strategies to address affordability, including local manufacturing, government funding, and partnerships with global health agencies, are essen

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… Abbreviations: AABB, American Association of Blood Banking; CT, computed tomography; FACT, Foundation for the Accreditation of Cellular Therapy; HEPA, high efficiency particulate air filter; HIC, high‐income countries; HSCT, hematopoietic stem cell transplant; JACIE, Joint Accreditation Committee—ISCT … activities to both local and global registries Both FACT‐JACIE and blood bank accreditation organizations (e.g., AABB) have basic and optimal standards for accreditation The goal should be to obtain certification within a few years of the first transplant. …

SNMMI/EANM/ASNC/ACNM procedure standard/practice guideline for 18F-Flurpiridaz PET myocardial perfusion imaging and blood flow quantitation.

The Society of Nuclear Medicine and Molecular Imaging (SNMMI), founded in 1954 and headquartered in Reston, Virginia, USA, is a nonprofit scientific and professional organization that promotes the science, technology, and practical application of nuclear medicine and molecular imaging. SNMMI strives to be a leader in unifying, advancing, and optimizing molecular imaging with the ultimate goal of improving human health. With 13,000 members worldwide, SNMMI represents nuclear and molecular imaging professionals, all of whom are committed to the advancement of the field. The European Association

Evaluation and management of obstructive sleep apnea in adults hospitalized for medical care: an American Academy of Sleep Medicine clinical practice guideline.

INTRODUCTION: The purpose of this guideline is to establish clinical practice recommendations for the management of obstructive sleep apnea (OSA) in medically hospitalized adults. METHODS: The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using Grading of Recommendations, Assessment, Development and Evaluation methodology. The task force provided a summary of the relevant literature and the certainty of evidence, th

Resistance in human pathogenic yeasts and filamentous fungi: prevalence, underlying molecular mechanisms and link to the use of antifungals in humans and the environment.

Antifungal drug resistance is a multifaceted clinical challenge, and when present, a primary cause of treatment failure in patients with severe fungal infections. Changing epidemiology, increasing resistance rates and a narrow antifungal armamentarium may further underline the required attention on resistance particularly within the most prevalent invasive fungal infections caused by Candida yeasts and Aspergillus moulds. In Denmark, the resistance epidemiology remains to be fully elucidated. This thesis sought to address this demand as well as provide insight into the landscape of underlying

Stopping Fistula Hemorrhage without Bleeding Time and Money - A Low Cost, Low Resource Hemodialysis Fistula Model for Emergency Medicine Residents.

AUDIENCE: This bleeding fistula model is designed to instruct emergency medicine residents and third- and fourth-year medical students on their emergency medicine rotation. INTRODUCTION: The prevalence of end-stage renal disease (ESRD) has increased since 2001 (808,536 people in 2021 versus 409,226 in 2001).1 About 14% of the United States population has a decreased glomerular filtration rate (GFR), and the overall presence of ESRD in the population as of 2021 was 2,219 per million population.1 As of 2021, 87.7% of patients receiving dialysis were on hemodialysis.2 Around 60% of dialysis pati

Rise in Minimally Invasive Surgery for Colorectal Cancer Is Associated With Adoption of Robotic Surgery.

BACKGROUND: Minimally invasive surgery is associated with improved short-term outcomes and similar long-term oncologic outcomes for patients with colorectal cancer compared with open surgery. Although the robotic approach has ergonomic and technical benefits, how it has impacted the utilization of traditional laparoscopic surgery and minimally invasive surgery overall is unclear. OBJECTIVE: Describe trends in open, robotic, and laparoscopic approaches for colorectal cancer resections and examine factors associated with minimally invasive surgery. DESIGN: Retrospective cohort study using data

Preoperative Antibiotics and Mechanical Bowel Preparation Impact the Colonic Mucosa-Associated Microbiota but Not Anastomotic Leak Rate After Colorectal Resection.

BACKGROUND: Alterations in the GI microbiome have been associated with increased anastomotic leak risk. Oral antibiotics and bowel preparations may both reduce anastomotic leak rates. OBJECTIVE: In patients undergoing colorectal surgery, we aimed to examine the impact of oral antibiotic use, bowel preparation, and other perioperative factors on the mucosa-associated microbiota and investigate the association with anastomotic leak rates. DESIGN: We opportunistically sampled Australian patients undergoing colorectal resection for any indication of anastomosis; mucosal swabs were taken from the

Minimum effective low dose of antithymocyte globulin in people aged 5-25 years with recent-onset stage 3 type 1 diabetes (MELD-ATG): a phase 2, multicentre, double-blind, randomised, placebo-controlled, adaptive dose-ranging trial.

BACKGROUND: Type 1 diabetes remains an important health-care problem, with no disease-modifying therapies available in people with recent-onset, clinical type 1 diabetes. Adaptive trial designs, allowing faster evaluation of treatment modalities, remain underexplored in this stage of the disease. We aimed to identify the minimum effective dose of antithymocyte globulin (ATG) in people aged 5-25 years with recent-onset, clinical type 1 diabetes. METHODS: MELD-ATG was a phase 2, double-blind, randomised, placebo-controlled, multi-arm, adaptive dose-ranging, parallel-cohort trial done in 14 accr

Anniversary Oncology Days in Paris.

On June 14-16 2023, the 45th meeting of the General Assembly of Organization of European Cancer Institutes (OECI) dedicated to the 120th ann … in access to digital, research and innovation technologies. The efforts of the team in the field of accreditation and certification of cancer centers within the framework of the European Cancer Plan help to improve and build the capacity of the EU member states to improve the quality of healthcare services. The OECI is working to support, improve and integrate …

Cell Count Differentials by Cytomorphology and Next-Generation Flow Cytometry in Bone Marrow Aspirate: An Evidence-Based Approach.

Despite a lack of evidence, a bone marrow aspirate differential of 500 cells is commonly used in the clinical setting. We aimed to test the performance of 200-cell counts for daily hematological workup. In total, 660 consecutive samples were analyzed recording differentials at 200 and 500 cells. Additionally, immunophenotype results and preanalytical issues were also evaluated. Clinical and statistical differences between both cutoffs and both methods were checked. An independent control group of 122 patients was included. All comparisons between both cutoffs and both methods for all relevant

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… Since 2011, as part of the ISO15189 Standard accreditation for BMCS, a quarterly internal quality control is used to estimate interobserver variability among the section staff. … Health impact assessment and the role of accredited clinical laboratory on ISO 15189:2007 International Standard J. US-China Med. Sci. 2011 8 588 595 16. …

Half a century of healing: celebrating the 50th anniversary of EBMT.

EBMT is a non-profit organization with a clear mission: "to save the lives of patients with blood cancers and other life-threatening diseases by advancing the fields of blood and marrow transplantation and cell therapy worldwide through science, education and advocacy". In 1974, EBMT was established by European physicians in St. Moritz to share bone marrow transplantation (BMT) experiences and foster collaboration. Founding members included Jon Van Rood, Bruno Speck, and Eliane Gluckman. By 1989, the group expanded significantly, emphasizing mutual trust and collaboration. EBMT played a crucia

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… Accreditation and benchmarking strategies EBMT has always been committed to accreditation and JACIE develops and maintain global standards for the provision of quality medical and laboratory practice in cellular therapy. … Based on these standards, JACIE offers accreditation to transplant programs in order to encourage health institutions and facilities to establish and maintain quality management systems. …

Donor Evaluation for Hematopoietic Stem and Progenitor Cell Collection

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… In many countries, however, accreditation is not mandatory for centers assessing RDs. … Improved compliance with internationally recognized donor care paradigms have been seen in centers with FACT-JACIE accreditation; however, important practice gaps in all centers irrespective of accreditation continue to be seen (Anthias et al. 2016a , b ). …

Enhancing medication adherence with blister-packed oral oncolytics: A case example in chronic lymphocytic leukemia.

IntroductionMedication nonadherence is a prevalent issue in the oncology population and can be costly on the healthcare system while leading to worsened outcomes, including increased mortality. One intervention that has been shown to help promote medication adherence to oral therapies for chronic conditions is blister-packaging. However, no literature is available assessing the potential impact of blister-packaging in oncology. Therefore, we aimed to quantify the impact of blister-packaging oral oncolytics on medication adherence and healthcare costs.MethodsAn economic model was designed to as

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… Two of the leading accreditation organizations in this space are URAC which provides accreditations for specialty pharmacies, 47 as well as NCODA which provides accreditations for medically integrated dispensing pharmacy centers of excellence. 46 As part of these accreditations, pharmacies are determined … NCODA accreditation program. National Community Oncology Dispensing Association, https://www.ncoda.org/accreditation/ (2021, accessed 3 April 2024). 47. URAC. Specialty pharmacy accreditation. URAC, https://www.urac.org/accreditation-cert/specialty-pharmacy/ (2024, accessed 3 April 2024). 48. …

Establishment of the First Comprehensive Adult and Pediatric Hematopoietic Stem Cell Transplant Unit in the United Arab Emirates: Rising to the Challenge.

Hematopoietic stem cell transplantation (HSCT) is increasingly indicated for various malignant and non-malignant diseases. In the United Arab Emirates (UAE), patients that could benefit from the procedure commonly need to seek medical care abroad in view of the lack of a comprehensive HSCT facility that could offer the full spectrum of interventions and monitoring protocols. This comes with considerable challenges related to coverage and logistics of travel. It also limits the continuity of clinical care, and presents inconvenience to patients who come from a different cultural background. In

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… By October 2023, we aim for the HSCT unit to be accredited by the Foundation for the Accreditation of Cellular Therapy—Joint Accreditation Committee (FACT-JACIE). … HSCT, hematopoietic stemcell transplantation; CAR-T, Chimeric antigen receptor T; FACT-JACIE, Foundation for the Accreditation of Cellular Therapy–Joint Accreditation Committee. 7. Conclusions As cliché as this may sound, our experience made us realize that where there is a will, there is a way. …

Chimeric antigen receptor T-cell therapy: Challenges and framework of outpatient administration.

Adoptive cellular therapy has made a landmark change within the treatment paradigm of several hematologic malignancies, and novel cellular therapy products, such as chimeric antigen receptor T-cell therapy (CART), have demonstrated impressive efficacy and produced durable responses. However, the CART treatment process is associated with significant toxicities, healthcare resource utilization, and financial burden. Most of these therapies have been administered in the inpatient setting due to their toxicity profile. Improved toxicity management strategies and a better understanding of cellular

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… An increasing number of industry‐sponsored CART studies are requiring FACT accreditation, but the practice has been variable. Meeting the REMS requirements is more feasible for independent community‐based practices without affiliation with the FACT accredited HCT program. … Accreditation requirements for CART programs require periodic team meetings to review potential patients for eligibility [ 20 ]. …