Summary
Q. How should a blood bank respond when a non-irradiated blood product is inadvertently transfused to a patient who requires irradiated components, and what steps must be taken to ensure patient safety and regulatory compliance?
Q. We are using direct smears for nongynecologic fine-needle aspirations and thinking about switching to liquid-based cytology (SurePath) preparation. There is nothing in the CAP accreditation checklist that pertains to a switch in slide preparation method…
Editors: Olga Pozdnyakova, MD, PhD, Geoffrey Wool, MD, PhD, David Bernard, MD, PhD & Raul S. Gonzalez, MD
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Q. How should a blood bank respond when a non-irradiated blood product is inadvertently transfused to a patient who requires irradiated components, and what steps must be taken to ensure patient safety and regulatory compliance?
A. March 2026—When a non-irradiated product is transfused to a patient who should have received irradiated components, such as a patient with acute myeloid leukemia, the event qualifies as a biological product deviation. A BPD occurs when there is an unexpected deviation in the manufacture, storage, or distribution of a blood product that may compromise its safety, purity, or potency. In this scenario, the medical director must immediately assess the patient for potential adverse outcomes, such as transfusion-associated graft-versus-host disease (TA-GVHD), a rare but potentially fatal complication. Documentation of all findings, communication with the patient’s care team, and close monitoring for delayed reactions are essential to ensuring patient safety and compliance with regulatory standards.
Beyond patient care, the medical director must follow the FDA reporting requirements outlined in 21 CFR §606.171, which mandate that any event affecting the safety, purity, or potency of a distributed blood product be reported within 45 days of discovery. The facility in control of the product at the time of the deviation is responsible for submitting the report. In this case, documenting the event internally within the hospital’s quality system, initiating a thorough root-cause investigation, and developing corrective and preventive actions are crucial steps. These actions not only demonstrate compliance but also strengthen the laboratory’s quality management system and align with both FDA regulations and CAP accreditation standards aimed at promoting patient safety and continuous quality improvement.
To review more about navigating blood bank regulations, a CAP Clinical Pathology Improvement Program case is available for purchase at https://bit.ly/CAP_CPIP. For current and past CPIP online activities, see https://education.cap.org/casebased.
Melissa R. George, DO
Medical Director of Transfusion Medicine
Pennsylvania State Health
Milton S. Hershey Medical Center
Associate Dean for Continuing Education
Penn State College of Medicine
Hershey, Pa.
Chair, CAP Clinical Pathology Education Committee