Transfusion medicine

• Increases blood bank testing and unit processing capacity and throughput compared with manual technique (Transfus Med Hemother 2021;48:290, Vox Sang 2013;105:225, Transfus Apher Sci 2015;53:58)
• Limits human errors and reduces staffing requirements (Asian J Transfus Sci 2015;9:S6)
• Improves test reproducibility, traceability and patient identification with the use of specimen barcodes (Transfus Med 2022;32:299)
• Requires extensive validation (which falls under the blood bank quality management structure) and must meet Food and Drug Administration (FDA) compliance (FDA: Part 11, Electronic Records; Electronic Signatures - Scope and Application [Accessed 8 February 2023])
• All equipment must be certified for safety and verified in compliance with Clinical Laboratory Improvement Amendments (CLIA) quality standards (Electronic Code of Federal Regulations: Part 493 - Laboratory Requirements [Accessed 4 May 2023])
• Guidelines for validation are provided by the International Society of Blood Transfusion (ISBT) (Vox Sang 2010;98:1)
• Automated systems are more costly to acquire and maintain than manual methods and must be compatible with the institution's informatics
• Specific sample collection requirements and staff training are vital for adequate function
• A backup system is necessary in anticipation of down time

C. Equipment verification is required before implementation. Answer A is incorrect because performance on proficiency testing is a way of monitoring specific tests or measurements of individual laboratories and comparing it with other laboratories. Answer B is incorrect, as the calibration of an instrument is a process for verification of the accuracy of results after implementation. Answer D is incorrect because inspections by accreditation agencies (e.g., CAP) aim to assess the compliance of a laboratory with the agency requirements.

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Reference: Automation

D. 87 year old man with anemia (Hgb 6.9 g/dL) and newly diagnosed multiple myeloma, no history of transfusions and a negative antibody screen. This answer is correct because the patient has no prior history of transfusions as well as a negative type and screen. Answer A is incorrect, as the patient's laboratory findings are consistent with hemolytic anemia likely attributed to a hemolytic transfusion reaction due to the presence of ≥ 1 alloantibodies suggested by the history of multiple transfusions. The patient's alloantibody(ies) must be identified in order to provide antigen negative full crossmatch compatible RBCs. Answer B is incorrect because a warm autoantibody causes a positive antibody screen and panagglutinin in the cell panel. Other special testing techniques (e.g., adsorption studies) are needed to rule out any alloantibodies in order to use electronic crossmatch. Answer C is incorrect since electronic crossmatching should not be used on patients with positive antibody screens without a certain alloantibody specificity.

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Reference: Automation