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PLASTIC RECONSTRUCTIVE AND REGENERATIVE SURGERY

Original article

Vol. 24 No. 5 (2026): Blood Transfusion 5-2026 (September-October)

Statistical quality control practices in a sample of Spanish Blood Establishments: a mixed-methods exploratory study

Authors

Hector Sarmiento Palao , María Isabel Ortiz de Salazar Martín , Luís Roberto Larrea Gonzalez , Ana María Arruga Manzano , María Luisa Ayape Puyales , Aida Isabel Azcarate Gonzalez , Teresa Díaz Rueda , Marta Lopez Melchor , Pascual Marco Vera , María del Carmen Martín Alonso , María Mercadillo González , Ana Isabel Perez Aliaga , Magdalena Prohens-Batle

Key words: quality control, blood establishments, statistical process control, blood components, mixed methods
DOI: 10.2450/BloodTransfus.1300
Organization and quality systems in transfusion medicine
Publication Date: 2026-09-18

Abstract

Background - The European Directorate for the Quality of Medicines & HealthCare (EDQM) provides guidance for statistical quality control in blood component manufacturing, including recommendations for sampling and statistical process control. However, the extent to which these recommendations are implemented in routine practice remains unclear.

Materials and methods - We conducted a sequential explanatory mixed-methods study among professionals working in blood establishments, recruited through the Spanish Society of Blood Transfusion blood processing working group. Phase 1 was a cross-sectional survey (10 responding centers across 10 autonomous communities; response rate 77%). Phase 2 comprised semi-structured interviews with a purposive sample of survey respondents (No.=7). Survey findings informed the interview topic guide. Thematic analysis followed the Braun and Clarke approach. Findings from both phases were integrated using a joint display.

Results - Respondents represented centers with varied production volumes, and most had more than 6 years of experience (80%). Use of statistical quality control methods was limited: 90% reported using descriptive statistics only and 10% used control charts. For sample size determination, 80% applied fixed production percentages without formal statistical justification. Spreadsheet-based workflows with custom formulas predominated (90%). Key challenges included determining sample size and laborious report generation (both 80%). Interviews highlighted uncertainty about sampling adequacy, potential for earlier trend detection, perceived complexity of guidance, and the need for interpretive decision support. All participants expressed interest in automated approaches.

Discussion - Among participating centers, variation in the implementation of statistical quality control practices relative to EDQM recommendations suggests opportunities for improved harmonization. Automated tools that embed recommended sampling and monitoring methods may support implementation, although larger studies are needed to estimate prevalence at national level.

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Authors

Hector Sarmiento Palao - Centro de Transfusiones de la Comunidad Valenciana, San Juan de Alicante, Spain https://orcid.org/0000-0003-4094-472X

María Isabel Ortiz de Salazar Martín - Centro de Transfusiones de la Comunidad Valenciana, San Juan de Alicante, Spain https://orcid.org/0000-0002-2034-6493

Luís Roberto Larrea Gonzalez - Centro de Transfusiones de la Comunidad Valenciana, Valencia, Spain; Departament of Medicine and Surgery, Health Sciences School, Universidad Cardenal Herrera-CEU, CEU Universities, Alfara del Patriarca, Valencia, Spain https://orcid.org/0000-0002-6364-8838

Ana María Arruga Manzano - Centro de Transfusion de la Comunidad de Madrid, Spain

María Luisa Ayape Puyales - Banco de Sangre y Tejidos de Navarra, Spain

Aida Isabel Azcarate Gonzalez - Centro Vasco de Transfusion y Tejidos Humanos, Pais Vasco, Spain https://orcid.org/0009-0007-6748-5902

Teresa Díaz Rueda - Centro de Transfusion de Cantabria - Hospital Marques de Valdecilla, Spain https://orcid.org/0000-0002-0460-3007

Marta Lopez Melchor - Centro de Transfusion, Tejidos y Celulas de Granada, Spain https://orcid.org/0009-0006-2536-9471

Pascual Marco Vera - Universidad Miguel Hernandez, Departamento de Medicina Clinica, Elche-Alicante, Spain https://orcid.org/0000-0002-3412-7566

María del Carmen Martín Alonso - Centro de Hemoterapia y Hemodonacion de Castilla y Leon, Spain https://orcid.org/0000-0001-8785-4225

María Mercadillo González - Direccion General de Hemodonacion y Hemoterapia, Canarias, Spain

Ana Isabel Perez Aliaga - Banco de Sangre y Tejidos de Aragon, Spain https://orcid.org/0009-0002-7796-9541

Magdalena Prohens-Batle - Fundació Banc de Sang i Teixits de les Illes Balears, Spain https://orcid.org/0009-0001-9192-5847

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