French national external quality assessment campaign for parenteral nutrition controls
1 October 2025
E. Kaczmar1, I. Soulairol2, T. Storme3, A. Venet4, P. Chennell5, R. Mazet6, External Quality Assessment Group of Hospital Control Laboratories7, C. Merienne11 Hospices Civils de Lyon, Edouard Herriot Hospital, Pharmacotechnics Unit, Lyon, France
2 Nîmes University Hospital, Pharmacy Department, Nîmes, France
3 APHP, Robert Debré Hospital, Pharmacy Department, Paris, France
4 Bordeaux University Hospital, Pharmacy Department, Bordeaux, France
5 Clermont-Ferrand University Hospital, University Clermont Auvergne, Clermont-Ferrand, France
6 Grenoble University Hospital, Pharmacy Department, Grenoble, France
7 APHP Cochin, APHP Debré, APHP Trousseau, Valenciennes Hospital, Poissy Saint Germain en Laye Intercommunal Hospital, Amiens University Hospital, Bordeaux University Hospital, Clermont-Ferrand University Hospital, Grenoble University Hospital, Limoges University Hospital, Martinique University Hospital, Mayotte University Hospital, Nancy University Hospital, Nantes University Hospital, Rennes University Hospital, Saint Etienne University Hospital, Toulouse University Hospital, Nice University Hospital, Tours University Hospital, Hospices Civils de Lyon (GHC and GHE)
Introduction
The quality of controls for parenteral nutrition preparations can be improved through inter-laboratory control [1]. In this work, we present an external quality assessment campaign through an inter-laboratory control consisting of analyzing outsourced internal quality controls in 21 French centers.
Materials and methods
Four stock solutions, 2 binary (B1 and B2) and 2 ternary (T1 and T2), were manufactured, aliquoted (N = 5), shipped to the centers (2-8°C), and controlled blindly. The results of the analyses of K+, Na+, Ca2+, Mg2+, osmolality, and glucose were compared according to the control capabilities of the centers. For each analysis (elemental, glucose, osmolality) of each mixture, the Z-Scores of each center were calculated according to the GTA 06 methodology of the ISO 15189 standard [1]. The specification is: Z-Score ≤ 2. The analytical techniques of each center were also specified.
Results
N = 1540 results were compared during this campaign. The Z-scores of 6 analyses performed on 4 bags (24 control charts) for the 21 centers highlighted 2 centers with unsatisfactory performance. One center had a Z-Score of 3.56 for Na+ analysis on B1, and another center had Z-Scores of 3.72 and 3.95 for K+ dosage on B1 and B2, respectively. The various analytical techniques used by the centers were: AAS, ICP or MP AES, CE, potentiometry, and colorimetry.
Discussion/conclusion
This campaign collectively strengthens our ability to make our processes and methods more reliable. The number of participants in this campaign (21 centers, including 2 in overseas territories) ensures sufficient statistical power for the tests and demonstrates the robustness of the methods. The next campaign by the external quality assessment group of hospital control laboratories will focus on the control of atropine dosage methods.