Quality control of intraoperative autologous blood salvage in cardiac surgery
August 2026—Patients undergoing cardiac surgery have a higher risk of excessive bleeding and complications due to dilutional effects during surgery and activation and consumption of platelets and coagulation factors. Increasing recognition of the related morbidity and mortality has heightened interest in patient blood management, including autologous blood salvage (ABS) using an automated cell-salvage system for safe and effective blood conservation in cardiac surgery with cardiopulmonary bypass. Of importance in adult and pediatric populations is that reinfused washed red blood cells be of high quality to prevent adverse events from cytolysis and activation processes and severe and fatal complications. The authors conducted a study to evaluate an ABS quality control system for intraoperative cardiac blood salvage. They also evaluated whether patient outcomes correlate with the use of homologous blood components during hospitalization and alterations in the quality control of recovered blood. The retrospective study was conducted at 27 hospitals in Brazil from January 2021 to December 2023. The quality assessment adhered to Brazilian regulatory standards that require hemotherapy services to meet a compliance rate of 75 percent or more for each quality control parameter. The authors used quality control metrics of washed autologous RBC concentrates that were recovered and then reinfused into patients. The quality control indicators were hematocrit between 50 and 75 percent, hemolysis rate of less than 0.8 percent, and residual protein of less than 0.5 g/unit. Out of 424 patients and 225,814 mL of intraoperatively recovered washed autologous RBCs, 576.6 autologous RBC units were recovered. The results showed that 94.6 percent of hematocrit measurements, 98.3 percent of hemolysis rates, and 98.4 percent of residual protein levels were within the acceptable quality control standards. Thirty-six (eight percent) cases fell outside the parameters, primarily due to hematocrit. The results also showed that those patients who required additional homologous blood components tended to be younger (p=.006), lighter weight, and female (p<.001). They also had lower preoperative hematocrit and hemoglobin levels (p<.001), received higher volumes and more units of recovered autologous RBC concentrate (p=.03 and p=.008, respectively), and experienced more complications in the operating room, ICU, and overall (p<.05). Preoperative anemia was found to be a predictor of adverse outcomes in patients undergoing coronary artery surgery and mixed cardiac surgical populations. This study supports statistical sampling, as recommended by the Association for the Advancement of Blood and Biotherapies, of at least one percent of the recovered units produced monthly or at least four procedures per month, whichever is greater. The authors concluded that ABS supports blood-conservation methods in cardiac surgery by reducing the need for allogeneic transfusions. Factors impacting patient outcomes include preoperative anemia, altered quality control, the need for homologous transfusion, and the occurrence of clinical and surgical complications.
Vieira SD, da Cunha Vieira Perini F, Dalmazzo LFF, et al. Quality control of intraoperative autologous blood salvage in cardiac surgery. Transfusion. 2025. doi.org/10.1111/trf.18384
Correspondence: Dr. Sérgio Domingos Vieira at sergio.vieira@grupogsh.com
Pharmacogenomic testing strategies and technical considerations for clinical laboratories
Many clinical laboratories are now performing pharmacogenomic testing to predict how a person will respond to medications. The results of such testing may be used in drug selection or dosing, or both. Many factors should be taken into account when deciding whether to offer pharmacogenomic (PGx) testing, including clinical utility, patient and physician outcome expectations, regulatory requirements, testing costs, and reimbursement. PGx testing involves assessing genes that encode drug-metabolizing enzymes, transporters, histocompatibility markers, and other proteins. In addition to better predicting treatment response with certain medications, PGx testing may provide a better understanding of gene-drug interactions that lead to potential adverse reactions and outcomes. It is important to ensure institutional buy-in for such testing because a framework based on PGx test design, validation, analysis, and reporting is essential for the program’s success. Standardization measures and PGx testing guidelines have been developed by several professional societies, including the Association for Molecular Pathology, College of American Pathologists, and Clinical Pharmacogenetics Implementation Consortium. These guidelines provide information that supports the use of PGx test results in clinical practice. The authors provided technical considerations to help clinical laboratories design, develop, validate, routinely perform, and report the results of clinical PGx tests. They were part of a workgroup formed by the College of American Pathologists that included representatives from the Association for Molecular Pathology and American College of Medical Genetics and Genomics. The members of the workgroup were considered experts in clinical PGx testing and tasked with reviewing pertinent literature and sharing experiences from proficiency testing and their own laboratories. Because many PGx tests are lab-developed tests rather than FDA-cleared test kits, they have been designed, developed, validated, and maintained by the laboratory under Clinical Laboratory Improvement Amendments requirements. The workgroup found that labs implementing PGx testing should focus on testing the platform; test design (that is, the selection of pharmacogenes and variants/alleles); use of reference materials during test development and as controls during clinical runs; star allele and standard nomenclature systems; translations from genotype to predicted phenotype; and considerations for result reporting, including medication recommendations. The authors noted that PGx testing is unique from other germline molecular tests and that standardization efforts have been beneficial. However, more work needs to be done, in part because PGx test results will likely be incorporated into EHR systems as structured data to facilitate the use of clinical decision-support tools. The authors concluded that clinical laboratories should be familiar with the fundamentals of PGx testing, ensure that tests and results comply with regulatory requirements and are evidence based, and follow recommendations for standardization.
Ji Y, Brunk L, Bove B, et al. Pharmacogenomic testing: strategies and technical considerations for clinical laboratories. Arch Pathol Lab Med. 2026. doi.org/10.5858/arpa.2025-0179-CP
Correspondence: Dr. Ann M. Moyer at moyer.ann@mayo.edu