Quality management in blood establishments

T, Vuk

doi:10.1111/j.1751-2824.2009.01212.x

Cited by 6 publications

(5 citation statements)

References 2 publications

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“…Therefore, the procedure of releasing a number of products from the same batch (as in pharmaceutical industry) is not applicable here. A system of statistical monitoring of various parameters to maintain constant quality should be established instead (Vuk, ). At the Croatian Institute of Transfusion Medicine (CITM), quality control of blood components has been performed in line with the valid acts and by laws, which have been harmonized with the European legislative.…”

mentioning

confidence: 99%

Quality control of leucocyte‐depleted platelet concentrates obtained by buffy‐coat method

Vuk

Patko

Gulan-Harcet

et al. 2013

Transfusion Medicine

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confidence: 99%

Quality control of leucocyte‐depleted platelet concentrates obtained by buffy‐coat method

Vuk

Patko

Gulan-Harcet

et al. 2013

Transfusion Medicine

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“…The highest percentage of non‐compliances for each inspection year referred to record keeping and documentation, (Figure 1). Like Vuk, we perceive proper documentation‐keeping as crucial for effective quality management system (QMS) 17 . It ensures process standardisation as well as traceability and monitoring of procedures.…”

Section: Discussionmentioning

confidence: 99%

“…Vuk, we perceive proper documentation-keeping as crucial for effective quality management system (QMS). 17 Unification of the implemented standards may be supported by joint inspections performed by representatives of various organisations. 21 Lately, much attention has been focused on the differences between BEs regarding QA implementation, inspection and accreditation systems and despite the effort, the BE approach is still heterogenous.…”

Section: Discussionmentioning

confidence: 99%

Introduction of EUBIS standards to upgrade inspections of blood establishments to improve the safety of blood transfusion: The Polish experience

Lachert,

Antoniewicz‐Papis,

Mikołowska

et al. 2023

Transfusion Medicine

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Background and ObjectivesThe competent authority (CA) responsible for external inspections of Polish blood establishments (BEs) and supervision of the quality system is the Institute of Haematology and Transfusion Medicine (IHTM). Before the implementation of the European Blood Inspection System (EuBIS) classification of non‐compliance, the IHTM inspections were conducted according to national guidelines and the non‐compliance‐related recommendations were based on the inspectors' own experience and interpretation of the observed problems. Since 2009, IHTM inspections were already performed according to EuBIS guidelines. The study assessed the impact of the EuBIS classification on the IHTM recommendations. We assumed that the implementation of consistent assessment criteria contributed to the upgrading of the quality of BE inspections.Materials and MethodsBE‐inspection protocols; 30 from 2009 to 2010 and 61 from 2016 to 2019. Non‐compliance‐related recommendations were classified according to the seriousness of non‐compliances (critical, major, other significant, and observation) and also to the area of BE activity (documentation, organisation of work, qualification and validation, pathway from donor qualification to blood component‐issue, quality control of blood components, adverse events and reactions).ResultsThe recommendations mostly referred to document‐keeping and work organisation and were distributed as follows: 2009–2 critical (others unclassified), 2010–1‐13 major, 4–25 other significant and 1–7 suggestions, 2016–2019–3‐9 critical, 90–196 major, and 157–297 other significant as well as 14–22 suggestions.ConclusionPolish BEs still require: integrated document management, analysis of IHTM recommendations, implementation of corrective and preventive measures and personnel training in identifying similar non‐compliances in other procedures.

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“…Errors may occur at any point, resulting in dire consequences for the blood donors, patients and the public at large. 1 , 2 …”

Section: Introductionmentioning

confidence: 99%

Implementing SLMTA in the Kenya National Blood Transfusion Service: lessons learned

Wakaria¹,

Rombo

Oduor

et al. 2017

Afr J Lab Med

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BackgroundThe Kenya National Blood Transfusion Service (KNBTS) is mandated to provide safe and sufficient blood and blood components for the country. In 2013, the KNBTS National Testing Laboratory and the six regional blood transfusion centres were enrolled in the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme. The process was supported by Global Communities with funding from the United States Centers for Disease Control and Prevention.MethodsThe SLMTA implementation at KNBTS followed the standard three-workshop series, on-site mentorships and audits. Baseline, midterm and exit audits were conducted at the seven facilities, using a standard checklist to measure progress. Given that SLMTA was designed for clinical and public health laboratories, key stakeholders, guided by Global Communities, tailored SLMTA materials to address blood transfusion services, and oriented trainers, auditors and mentors on the same.ResultsThe seven facilities moved from an average of zero stars at baseline to an average of three stars at the exit audit. The average baseline audit score was 38% (97 points), midterm 71% (183 points) and exit audit 79% (205 points). The Occurrence Management and Process Improvement quality system essential had the largest improvement (at 67 percentage points), from baseline to exit, whereas Facilities and Safety had the smallest improvement (at 31 percentage points).ConclusionSLMTA can be an effective tool for preparing a blood transfusion service for accreditation. Key success factors included customising SLMTA to blood transfusion activities; sensitising trainers, mentors and auditors on operations of blood transfusion service; creating SLMTA champions in key departments; and integrating other blood transfusion-specific accreditation standards into SLMTA.

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Quality management in blood establishments

Cited by 6 publications

References 2 publications

Quality control of leucocyte‐depleted platelet concentrates obtained by buffy‐coat method

Quality control of leucocyte‐depleted platelet concentrates obtained by buffy‐coat method

Introduction of EUBIS standards to upgrade inspections of blood establishments to improve the safety of blood transfusion: The Polish experience

Implementing SLMTA in the Kenya National Blood Transfusion Service: lessons learned

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