How do we achieve blinding in modern electronic and paper medical records during the conduct of transfusion trials?

BACKGROUND: Regulatory aspects of transfusion medicine add complexity in blinded transfusion trials when considering various electronic record keeping software and blood administration processes. The aim of this study is to explore strategies when blinding transfusion components and products in paper and electronic medical records. METHODS: Surveys were collected and interviews were conducted for 18 sites across various jurisdictions in North America to determine solutions applied in previous transfusion randomized control trials. RESULTS: Sixteen responses were collected of which 11 had previously participated in a transfusion randomized control trial. Various solutions were reported which were specific to the laboratory information system (LIS) and electronic medical record (EMR) combinations although solutions could be grouped into four categories which included the creation of a study product code in the LIS, preventing the transmission of data from the LIS to the EMR, utilizing specialized stickers and labels to conceal product containers and documents in the paper records, and modified bedside procedures and documentation. DISCUSSION: LIS and EMR combinations varied across sites, so it was not possible to determine combination-specific solutions. The study was able to highlight solutions that may be emphasized in future iterations of LIS and EMR software as well as procedural changes that may minimize the risk of unblinding.

Therapy related acute myeloid leukemia with blast cannibalism and cytophagocytosis.

The case of an 83-year old male patient is described. He presented to our hospital with a 2 week history of intermittent syncope and was diagnosed with atrial fibrillation. His CBC showed bicytopenia with anemia and neutropenia in context of a leucoerythroblastic blood film and blastemia. As the patient was previously diagnosed with stage IV diffuse large B cell lymphoma; treated with CHOP-R a bone marrow biopsy was requested to rule out acute leukemia. A cellular bone marrow aspirate showed presence of a myeloblast infiltrate (32.6%; confirmed by flow cytometry). Interestingly blast phagocytosis of terminally differentiated cells along with cannibalism of other blasts was identified. The diagnosis of therapy-related acute myeloid leukemia was reached and a palliative consultation was requested. To our knowledge, this is the first report of blast cytophagocytosis and cannibalism associated with a therapy-related acute myeloid leukemia with a complex karyotype.

The successful implementation of an automated institution-wide assessment of hemoglobin and ABO typing to dynamically estimate red blood cell inventory requirements.

BACKGROUND: Blood bank inventories must balance adequate supply with minimal outdate rates. The day-to-day practice of ordering red blood cell (RBC) inventory usually involves manually comparing current inventory levels with predetermined thresholds calculated from historical usage and ordering the difference. To date, there have been no published methods for ordering RBC inventory based on laboratory characteristics of admitted patients. STUDY DESIGN AND METHODS: We designed and implemented a blood ordering algorithm to provide a more accurate measure of predicted RBC utilization in our institution. Cerner Command Language (Cerner Millennium) was used to extract and combine historical RBC unit usage, current inventory levels, and system-wide hematology values and blood groups. This report contains a suggested order based on current inventory, historical inventory data, ABO group, and the current "anemia index" for the institution. RESULTS: The mean daily total RBC inventory was significantly reduced after implementation (401.7 units vs. 309.0 units, p < 0.05). There was a significant reduction in monthly RBC outdates in this period (19.1 vs. 8.1, p < 0.05). The age of RBCs at time of transfusion was reduced as well. CONCLUSION: We developed a novel algorithm that automatically generates a suggested RBC inventory order using real-time hospital-wide survey of patient ABO typing, hematology values, and historical data. After implementation of the algorithm we demonstrated a significant reduction in daily inventory levels and RBC outdate rates.