A Danish national, multicentre evaluation of the new donor vigilance system among different staff groups.

BACKGROUND AND OBJECTIVES: Two years after implementing a new national donor vigilance system, the Danish Haemovigilance Committee conducted a nationwide survey to evaluate the implementation among different staff groups. We present the results here. MATERIALS AND METHODS: The study was designed as an anonymous online survey to evaluate the satisfaction with the new registration, understanding of the parameters used and the user-friendliness. The REDCap platform was used. The questionnaire consisted of 22 questions. Ordinal variables were answered using five-point Likert scale (1 = strongly disagree to 5 = strongly agree). The data were analysed using descriptive statistics. Successful implementation was defined as mean overall satisfaction ≥4 and mean understanding of the individual components (adverse reaction category, severity and imputability) in the registration ≥4. RESULTS: In all, 104 staff members (77.9% donation staff) participated. The mean (SD) overall satisfaction among all participants was 3.96 (0.94), highest among medical doctors (4.43 (0.78)) and lowest for administrative or other personnel (2.78 (1.09)). The mean scores for understanding the adverse reaction categories, severity and imputability were 3.92 (0.94), 3.92 (0.94) and 3.88 (1.00), respectively. Experience with a previous donor vigilance system was associated with lower scores. The most successful implementation programme included a medical doctor for introduction and a contact person. CONCLUSION: The goal for successful implementation was not met. However, the overall attitude towards the new registration was positive and indicates that the system is suitable for different staff groups. Our results suggest that implementation could benefit from special attention to administrative staff and those accustomed to another donor vigilance system.

The new donor vigilance system in Denmark reveals regional differences in adverse reactions supposedly caused by variation in the registration.

BACKGROUND AND OBJECTIVES: In recent years, there has been an increased focus among blood bank professionals on the health and safety of blood donors. In 2019, the Danish Haemovigilance Committee designed a national donor vigilance system to improve the registration of adverse reactions (AR) in blood donors. The new donor vigilance system was implemented on 1 January 2020 and we here present the results from the first year of registration. MATERIALS AND METHODS: AR categories, severity level and imputability score were defined based on the definitions from the International Society of Blood Transfusion, AABB and the European Commission directive 2005/61/EC, respectively. RESULTS: Across all severity levels, AR in Danish blood donors were found to be rare (1498 per 100,000 donations). Only 0.2% of the registered reactions were classified as serious (2.7 per 100,000 donations). Large regional differences were seen in the registration of citrate reactions and haematomas. CONCLUSION: Significant differences across regions in what to categorize as an AR were persistent even when including a severity score in the reporting. The Danish Haemovigilance Committee will commence a national work to align the definitions but suggests that this matter is raised to an international level as part of the current work to agree upon definitions for assessment of donor AR.

Evaluation of the Sysmex XN automated hematopoietic progenitor cell enumeration for timing of peripheral blood stem cell harvest.

BACKGROUND: Enumeration of stem cells is essential in the management of peripheral blood stem cell (PBSC) harvest. An alternative to the gold standard flow cytometric CD34+ stem cell count is the fully automated hematopoietic stem cell (HPC) count on the Sysmex XN hematology analyzer. MATERIALS AND METHODS: Eighty-nine patients and healthy stem cell donors who underwent PBSC harvest were included in the study. Stem cells were enumerated in pre-harvest peripheral blood and the apheresis yield by both flow cytometric CD34+ stem cell enumeration and by the Sysmex XN HPC count. RESULTS: The Sysmex HPC concentration overestimated the CD34+ stem cell concentration by a ratio of 1.3 in average. The agreement between the two methods was poor at concentration <40 stem cells/µL (Bias: 45 %, 95 % limits of agreement: -71 - 160 %). CD34+ stem cell concentration and HPC concentration correlated well in pre-harvest peripheral blood (R=0.73, slope=0.96). We established a positive cut off >43.5 HPC/µL, where PBSC harvest can be initiated. And a negative cut off <16.5 HPC/µL, where harvest should be postponed or other mobilizing regimens or bone marrow harvest should be considered. 33 % of measurements were in between the negative and positive cut-off and would require a supplementary CD34+ cell count. CONCLUSION: Although Sysmex HPC count correlates well with CD34+ cell count in peripheral blood, the agreement between the two methods is poor, especially at low concentrations, namely in the clinical decision range. Sysmex HPC count as a surrogate for CD34+ cell count should, therefore, be used with caution.

Collection of peripheral blood progenitor cells for autologous use: performance enhancements of COBE spectra, auto-PBSC.

Collection of peripheral blood stem cells (PBSC) must be performed in a safe and effective manner. Issues like automation, collection efficiency (CE), and adverse events must be considered. Auto-PBSC (COBE Spectra) is a fully automated program for PBSC collection. Changes in the protocol were made to achieve high CE, low product volume, and resulted in three groups of patients. Standard operating procedures (SOPs) were developed to reduce citrate toxicity and patients with central venous catheter. Twenty patients and 27 collections (Group 1), 88 patients and 112 collections (Group 2), and 158 patients and 194 collections (Group 3) were recorded. The protocol changes increased CE significantly from 31% (Group 1) to 57 and 59% (Group 2 and 3). Adjusting endpoint according to the preapheresis number of CD34+ cells reduced the collection time and the volume of the product significantly (median 227 min and 56 mL) without affecting CE. Mean level of ionized calcium before collection was 1.22 mmol/L, measured in 31 patients. This declined to a mean of 1.07 mmol/L after 1 h of collection and remained unchanged despite continuous calcium infusion. The number of patients with mild symptoms of citrate toxicity was reduced from 20 to 6%. A central venous catheter was used in 15%. Compared to peripheral access no differences in blood flow rate or time to perform the collection were found. Changes in the Auto-PBSC protocol resulted in an improved CE and a small product. SOPs reduced the number of patients with citrate toxicity and with central venous catheter.