Sapey T^*1, Blin M¹, Dubois AM ², Leo S³

1. ARS Centre Val de loire, Cellule Régionalehémovigilance, France

2. ARS Centre- Val de Loire, Mission Inspection contrôle, France

3. ARS Bourgogne Franche-Comté, Cellule Régionalehémovigilance, France

^*Corresponding author:Dr.SapeyThierry,Regional Haemovigilance and Blood Safety Coordinator, Department of public and environmental health, ARS Center Val de Loire, 131 rue du faubourgBannier-BP 74409 , 45044 Orléanscedex 1, France, E-mail:thierry.sapey@ars.sante.fr

Abstract

The Center-Val de Loire region (CVL) has 30 blood banks (2 Deliveries Banks (DB), 2 Relay Banks (RB), 1 Emergency Bank (EB), 25 Emergency / Relay Banks (ERB)) distributed over all these 6 departments. The Bourgogne-Franche-Comté (BFC) region has 22 blood banks (16 DB, 4 EB, 2 ERB) distributed over all these 8 departments. The French reglementation requires the production of at least one control during the period of validity of the authorization (5 years). The aim of our work is to compare the results between these two regions.The study concerns 50 establishments of health with a blood bank (18 DB, 2 RB, 3 EB, 27 ERB). The remarks and discrepancies appearing on the inspection reports led to administrative decisions (recommendations, prescriptions, injunctions) according to the gravity and the presence of a legislative text. They were arbitrarily classified into 6 groups (blood bank staff, data computer system, transport, equipment, documents and non-updated agreement). 97 remarks were collected in CVL, 71 in BFC, 169 discrepancies in CVL, 160 in CFB. The problems with blood bank staff dominate in both regions, followed by problems related to equipment and document. Injunctions are more frequent in CVL but for the same type than in BFC (blood bank staff and equipment). The results of the blood bank control of the 2 regions are quite comparable. The majority of anomalies have related with the blood bank staff. Injunctions are more frequent in CVL than in BFC.

Keywords: blood bank, inspection, risk management qualityassessment

Introduction

The Center-Val de Loire region (CVL) has 30 blood banks (2 Deliveries Banks (DB), 2 Relay Banks (RB), 1 Emergency Bank (EB), 25 Emergency / Relay Banks (ERB)) distributed over all these 6 departments. The Bourgogne-Franche-Comté (BFC) region has 22 blood banks (16 DB, 4 EB, 2 ERB) distributed over all these 8 departments. The French reglementation requires the production of at least one control during the period of validity of the authorization (5 years). The aim of our work is to compare the results between these two regions. That is also a good point of view over the blood banks in France.

Materials and Methods

The analysis concerns 50 Health Center (HC) with a blood bank (18DB, 2 RB, 3 EB, 27 ERB). The inspection of Blood Banks is part of a double legal framework: The French reglementation requires the production of at least one control during the period of validity of the authorization (5 years). The remarks and discrepancies appearing on the inspection reports led to administrative decisions (recommendations, prescriptions, injunctions) according to the gravity and the presence of a legislative text.

The definitions are as follows [1]: A remark is an expression of a more or less serious defect perceived by the inspection mission and which cannot be characterized in relation to a legislative text. A discrepancy is an expression of non-compliance with respect to an opposable legislative text. One recommendation relates to a low risk default that was found in the absence of a legal reference text. A prescription follows the finding of a discrepancy in relation to an opposable legislative text. It’s a latent risk that needs attention.

An injunction follows the finding of a discrepancy in relation to an opposable legislative text. It relates to a critical and patent risk. It’s a prerequisite for a « heavy » measure fixed by the law (closure, action on authorization).They were arbitrarily classified into 6 groups (blood bank staff, data computer system, transport, equipment, documents and non-updated agreement) +

Results

97 remarks were collected in CVL, 71 in BFC, 169 discrepancies in CVL, 160 in BFC. The results of the administrative decisions of each region are shown in Table 1. 63 % of administrative decisions in CVL, 69% in BFC are related to prescriptions or injunctions. The administrative decisions relating to blood bank staff are in the majority in the 2 regions. It’s most often the absence of a training process for personnel authorized to use the blood bank (formalization of initial training, accreditation). The absence of regulatory training [2] is responsible for most of the injunctions. In second position, the anomalies related to documents (absence or update not carried out). Third, problems related to the equipment, in particular the absence of a maintenance contract and the qualification of conservation equipment [3].

Table 1. The results of the administrative decisions of each region CVL and BFC./