Chester Andrzejewski

Multiple myeloma light chain cast nephropathy (LCCN) is often treated with plasma exchange (PLEX) or the anti‐CD38 monoclonal antibody, daratumumab. However, rigorous studies supporting these therapies for LCCN are limited. Using data from 25 U.S.‐based academic cancer centers, we conducted two target trials examining the association between early receipt of PLEX or early receipt of daratumumab and kidney recovery in patients with newly diagnosed LCCN. Kidney recovery was defined as being alive, not on kidney replacement therapy, and with an improvement of at least one stage of AKI severity, all assessed at 90 days. Secondary outcomes included kidney recovery at 60 and 180 days. Logistic regression with propensity score overlap weights was used to adjust for confounders. Of 549 eligible patients for the PLEX target trial, 158 (28.8%) received PLEX. There was no association between PLEX and kidney recovery at 90 days (OR 1.48, 95% CI: 0.96–2.30). However, in subgroup analyses, PLEX was associated with higher odds of kidney recovery at 90 days among patients with newly diagnosed multiple myeloma compared to those with relapsed disease, as well as higher odds of kidney recovery among those with Stage 3 versus Stage 1 or 2 AKI at the time of LCCN diagnosis. Of 474 patients eligible for the daratumumab target trial, 136 (28.7%) received daratumumab. Daratumumab was not associated with kidney recovery at 90 days (OR 1.46, 95% CI: 0.84–2.55). Thus, in this multicenter cohort study, neither PLEX nor daratumumab was associated with kidney recovery at 90 days.

In 2007, the American Society for Apheresis (ASFA) published guidance for physician documentation related to oversight of therapeutic apheresis (TA). Due to 21st century changes in healthcare delivery, the ASFA Board of Directors (BOD) charged its Public Affairs and Advocacy Committee (PAAC) to coordinate a review and update of the guidance. PAAC members reviewed minutes from various ASFA committees' earlier deliberations and sought additional information from the medical and general literature and regulatory/professional organizations involved with medical records documentation as well as from ASFA membership. A draft document was developed, reviewed, and approved by pertinent parties with changes incorporated into the guidance revision. Major change agents impacting TA documentation were identified including the importance of multidisciplinary care teams, the adoption of telemedicine in TA delivery, and the challenges highlighted by the SARS‐CoV‐2 pandemic. Formats involving TA documentation scenarios related to initial TA consultations and subsequent care activities by TA staff were developed. The introduction of new technologies, the advancing and mandating of electronic medical records (EMRs) adoption and a renewed emphasis on the team‐based nature of healthcare delivery have all impacted TA services. Revised documentation formatting practices related to these changes, not only for physicians' involvement but recognition and inclusion of other members of multidisciplinary teams participating in TA, should be incorporated into TA operations. Such revisions can potentially enhance patient care and provide a foundation for TA‐related biovigilance activities.

Background: Pulmonary complications of blood transfusion, including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), and transfusion-associated dyspnea, are generally underdiagnosed and under-reported. The international TRALI and TACO definitions have recently been updated. Currently, no standardized pulmonary transfusion reaction reporting form exists and most of the hemovigilance forms have not yet incorporated the updated definitions. We developed a harmonized reporting form, aimed at improved data collection on pulmonary transfusion reactions for hemovigilance and research purposes by developing a standardized model reporting form and flowchart.Materials and Methods: Using a modified Delphi method among an international, multidisciplinary panel of 24 hemovigilance experts, detailed recommendations were developed for a standardized model reporting form for pulmonary complications of blood transfusion. Two Delphi rounds, including scoring systems, took place and several subsequent meetings were held to discuss issues and obtain consensus. Additionally, a flowchart was developed incorporating recently published redefinitions of pulmonary transfusion reactions.Results: In total, 17 participants completed the first questionnaire (70.8% response rate) and 14 participants completed the second questionnaire (58.3% response rate). According to the results from the questionnaires, the standardized model reporting form was divided into various subcategories: general information, patient history and transfusion characteristics, reaction details, investigations, treatment and supportive care, narrative, and transfused product.Conclusion: In this article, we present the recommendations from a global group of experts in the hemovigilance field. The standardized model reporting form and flowchart provide an initiative that may improve data collected to address pulmonary transfusion reactions.

BACKGROUND: Suspected transfusion reaction (STR) investigations are foundational for biovigilance. Diagnostic evaluations performed by blood banks may prolong turnaround times (TATs) for final STR results reporting. We identified a quality improvement opportunity using diagnostic testing reflex algorithms and our hospital's patient electronic health record to enhance TATs regarding one aspect of STR results reporting.STUDY DESIGN AND METHODS: We conducted a descriptive quality improvement study of reported STR cases investigated by our hospital's blood bank from March 1, 2014, to December 31, 2016, using data obtained from consult reports/quality improvement databases examining the number and types of diagnostic algorithm reflex activations performed and the TATs for an electronic provisional diagnosis reporting (PDXR) related to them.RESULTS: A total of 461 STR events occurred during the study interval, of which 150 involved no reflex testing. In the remainder of cases (n = 311), a total of 448 reflex activations occurred. In those cases in which PDXR occurred (n = 446), the median PDXR TAT during the first month of implementation was 325 minutes, which progressively decreased to 70 minutes or less approximately 1 year after implementation. By the last quarter of 2015, median TATs were 60 minutes or less in length, where they remained for the duration of the study.CONCLUSION: Technologists using targeted diagnostic reflex arcs to expedite laboratory testing along with STR electronic PDXR improve communication and timely results/information dissemination, potentially aiding bedside hemotherapy‐related clinical decision making.

BACKGROUND: Monitoring of patients' vital sign values (VSVs) during hemotherapy may have an important role in the recognition and mitigation of transfusion‐associated circulatory overload (TACO). Knowledge regarding VSVs and other patient characteristics in bedside‐reported TACO or fluid challenge–suspected transfusion reactions (TACO/FC‐STRs) is limited.STUDY DESIGN AND METHODS: We performed a retrospective observational cohort study of cases of uncomplicated red blood cell (RBC) transfusions (UCTs) and reported suspected transfusion reaction (STR) cases investigated by our hospital's transfusion medicine service (TMS) from January 1, 2005, to February 29, 2008, using data obtained from TMS consult reports and quality improvement databases examining VSVs and patient characteristics in TACO/FC‐STRs.RESULTS: The frequency of TACO/FC‐STRs was 0.19% per all RBC units transfused (1:530 units transfused). Both clinically and statistically (p ≤ 0.05) significant changes were encountered in all VSVs in patients experiencing TACO/FC‐STRs either at the 15‐minute time interval or at the end‐of‐transfusion time points. Measured and derived VSVs related to the patients' blood pressure in the peritransfusion period were consistently increased. Approximately two‐thirds of TACO/FC‐STR patients also exhibited inflammatory related signs and symptoms at STR bedside presentation. Differences (all p ≤ 0.050) between UCT and TACO/FC‐STR cohorts were seen for patient mean weights (80 kg vs. 72 kg), mean minutes to transfusion completion (121 min vs. 83 min), and mean storage age of suspected sentinel RBC unit (22.5 days vs. 25.2 days).CONCLUSION: Trend monitoring of peritransfusion VSVs, especially blood pressures, may aid in the bedside recognition of TACO/FC‐STRs. A subset of these patients may also present with febrile and/or inflammatory signs and symptoms.

Introduction: Physician supervision of apheresis contributes to safe and high‐quality patient care. Literature is limited regarding the requirements for hospital privileges of physicians providing apheresis services. This report provides recommendations from the American Society for Apheresis (ASFA) regarding this topic. Materials and Methods: The ASFA Public Affairs Committee was charged by the society's Board of Directors (BOD) to work collaboratively with other ASFA committees to develop guidance pertaining to requirements for hospital privileges of physicians in apheresis medicine. After review of the literature and discussions with members from diverse practice environments, draft guidance was created and circulated among pertinent parties for comment and revision. The final document, approved by the BOD in 2011, is presented herein. Results: Assurance of patient safety was the paramount focus in the deliberations. Establishment and maintenance of physician competency in the discipline of apheresis medicine, and the documentation thereof, were consensus priorities. The importance of care teams involving non‐physicians and the support structures within hospitals were also identified as other important contributors to patient safety. Conclusion: Patient safety during therapeutic apheresis involves both practitioners' and institutional provision of care aspects. Physician training experiences, medical licensing, and board certification status, along with continuing medical education and participation in risk management/patient safety projects are characteristic facets of physician competency in the provision of quality apheresis medicine interventions. Documentation of such indicators may help in medical staff deliberations regarding physician privileging in the oversight and management of apheresis medicine activities in hospitals. J. Clin. Apheresis, 2012.