Preliminary hazard analysis applied to outsourcing sterile chemotherapy preparations.

Background Our hospital organization raised the possibilities of outsourcing their sterile pediatric chemotherapy preparations to another hospital conditional on analyzing the potential hazardous events that need to be anticipated. Methods The study was conducted by a multidisciplinary working group from September 2015 to January 2016 with the support of a risk manager. A list of hazardous situations that could occur during outsourcing process was assessed. First, a map of hazardous situations was developed by crossing outsourcing processes divided into phases classified as critical or not. Second, a map of risk was established by crossing potential consequences of these hazardous situations and elaborating corrective actions to reduce the initial risks. Results The map of hazardous situations identified 183 relevant hazardous situations, 78 of which were considered high priority and 154 scenarios were developed. Slightly more than half of these hazardous situations concerned information system (30%), human resources (14%), and management (11%). The generic hazards of information system and human generated 37 (24%) and 41 (27%) scenarios, respectively. To reduce critical risks, 33 corrective actions were proposed. Working time required was estimated at 35 days. The subcontractor personnel for this new organization included an estimated extra time of 0.7-pharmacist working day and 1.4-pharmacy dispenser working day. Conclusions The preliminary hazard analysis method appeared to apply to our system of outsourcing sterile cytotoxic preparations in another hospital. Regardless, this analysis is complex and requires time and expertise.

Liposomes for PET and MR Imaging and for Dual Targeting (Magnetic Field/Glucose Moiety): Synthesis, Properties, and in Vivo Studies.

We describe the potentiality of a new liposomal formulation enabling positron emission tomography (PET) and magnetic resonance MR() imaging. The bimodality is achieved by coupling a 68Ga-based radiotracer on the bilayer of magnetic liposomes. In order to enhance the targeting properties obtained under a permanent magnetic field, a sugar moiety was added in the lipid formulation. Two new phospholipids were synthesized, one with a specific chelator of 68Ga (DSPE-PEG-NODAGA) and one with a glucose moiety (DSPE-PEG-glucose). The liposomes were produced according to a fast and safe process, with a high radiolabeling yield. MR and PET imaging were performed on mice bearing human glioblastoma tumors (U87MG) after iv injection. The accumulation of the liposomes in solid tumor is evidenced by MR imaging and the amount is evaluated in vivo and ex vivo according to PET imaging. An efficient magnetic targeting is achieved with these new magnetic liposomes.

Quantitation of human herpesvirus-6A, -6B and -7 DNAs in whole blood, mononuclear and polymorphonuclear cell fractions from healthy blood donors.

BACKGROUND: Diagnosis of human herpesvirus-6A (HHV-6A), -6B (HHV-6B) or -7 (HHV-7) infections is often based on the measure of viral load in blood. OBJECTIVES: The aim of this study was to define usual values of HHV-6A, HHV-6B and HHV-7 loads in blood fractions (whole blood [WB], mononuclear cells [PBMCs], polymorphonuclear leukocytes [PMNLs]) of blood donors. STUDY DESIGN: HHV-6A, HHV-6B and -7 DNAs were quantitated using real-time PCR assays in WB, PBMCs and PMNLs separated on Ficoll or dextran gradients, respectively, for 200 blood donors. Viral loads were expressed as the number of viral genomic copies per million cells (Cop/M) for all fractions, and also per milliliter for WB. RESULTS: HHV-6B DNA was rarely detected in WB (8%), PBMCs (16.5%), and PMNLs (10.5%), HHV-6A was never detected, whereas HHV-7 DNA was often present in WB (51.5%), PBMCs (62%) and PMNLs (51.5%). Median loads were low with 81 Cop/M in WB, 62 Cop/M in PBMCs and 34.5 Cop/M in PMNLs for HHV-6B, and 129 Cop/M in WB, 225 Cop/M in PBMCs and 62 Cop/M in PMNLs for HHV-7. Viral load expression per million cells and per mL were equivalent. One subject had chromosomally integrated HHV-6 with high viral loads ranging from 2.23×10(6) to 3.21×10(6) Cop/M in all compartments and plasma. CONCLUSIONS: These results allow to propose viral load in WB as a sensitive and suitable marker, with values for healthy subjects at approximately 100 Cop/M for both viruses. The prevalence of chromosomally integrated HHV-6 was 0.5%.