OBJECTIVE: Hemovigilance is a set of monitoring methods that covers the blood transfusion chain, from collecting blood and blood products to monitoring the blood recipients. To this end, any error in this process can have serious and irreparable consequences for patients. The present study aimed to investigate the quality of hemovigilance process in Iran, using the first two steps of Six Sigma model.
METHODS: This was a quantitative cross-sectional study that was conducted over 6 months (from August 20, 2021, to February 20, 2022) at Afzalipour Hospital in Iran, using the first two steps of Six Sigma model. The study population comprised of all inpatients who needed blood or blood product transfusion in various departments of Afzalipour Hospital, among whom 477 patients were selected via stratified sampling in three shifts (morning, evening, and night). The datasheet was used to record errors in the three shifts. This research was conducted, using the DMAIC cycle\'s \"define\" and \"measure\" steps.
RESULTS: In the define step, the hemovigilance process at Afzalipour Hospital was divided into two categories of normal process and emergency process. Each of these processes consists of several sub-processes, including \"phlebotomy,\" \"requesting blood and blood products from the department,\" \"preparation of application by the blood bank,\" \" sending a request from the blood bank to the blood transfusion center,\" \"transfusing blood and blood products,\" and \"returning the blood and blood products to the blood bank and waste disposal.\" In the measure step, the quality of hemovigilance process was evaluated based on sub-processes and labels at morning, evening and night shifts. The sub-process of sending a request from the blood bank to the blood transfusion center had the highest error rate with a sigma level of 1.5. Also, the evening and night shifts had a sigma level of 1.875, and the clinical and registration labels had a sigma level of 1.875. The overall sigma level of hemovigilance process was calculated to be 2.
CONCLUSIONS: The results of this study showed that the quality of hemovigilance process at Afzalipour Hospital was poor. By employing the first two steps of Six Sigma method, we identified the existing errors in the hemovigilance process of Afzalipour hospital in order to assist hospital managers to take the necessary measures to improve this process.

OBJECTIVE: Voluntary non-remunerated blood donors (VNRBDs) are recognized as being crucial for the safety and sustainability of national blood supplies. Systems based on replacement donors (RDs) pose high risks of transfusion transmissible infections (TTIs). Currently, only 10%-13% of blood donations are voluntary in Pakistan. No large-scale studies have been conducted to objectively evaluate the impact of the mode of donation on the frequency of TTIs, a gap this study aimed to fill.
METHODS: The study was conducted at the Indus Hospital, Karachi. Data from a total of 591,820 blood donations were included from 1 October 2017 to 30 May 2021 and evaluated for type of donations and results of TTI testing, primarily performed on Architect i2000SR (Abbott). The TTIs tested include hepatitis B virus, hepatitis C virus, human immunodeficiency virus, syphilis and malaria.
RESULTS: A total of 477,938 (80.7%) RDs and 113,882 (19.3%) VNRBDs were screened. Among these, 53,590 (9.06%) were positive for TTIs. There were 10.2% positive RDs (10.08-10.25 95% confidence interval [CI]) while 4.4% in VNRBDs (4.29-4.53 95% CI). Co-infections were observed in 2367 (0.4%) RDs, while 159 (0.02%) in VNRBDs. Geographically, the highest frequency of TTIs was observed in semi-urban areas of Sindh (11.2%) and Punjab (9.6%). A site-wise comparison of TTIs in RD versus VNRBD showed significant differences (p-value 0.00).
CONCLUSIONS: RDs are associated with higher frequencies of TTIs, compared with VNRBD. However, the study was unable to assess whether the significant difference was related to individual risk or repeat/first time status of the donors. Other important variables affecting frequency are the catchment area of the blood donors in Pakistan. Urban areas have less prevalence than semi-urban areas.

Hemovigilance (HV) is usually based on voluntary reports (passive HV). Our aim is to ascertain credible incidence, severity, and mortality of transfusion-associated adverse events (TAAEs) using an active HV program.
Prospective cohort study to estimate transfusion risk after 46,488 transfusions in 5830 patients, using an active HV program with follow-up within the first 24 h after transfusion. We compared these results to those with the previously established passive HV program during the same 30 months of the study. We explored factors associated with the occurrence of TAAEs using generalized estimating equations models.
With the active HV program TAAEs incidence was 57.3 (95% CI, 50.5-64.2) and mortality 1.1 (95% CI, 0.13-2.01) per 10,000 transfusions. Incidence with the new surveillance model was 14.0 times higher than with the passive. Most events occurred when transfusions had already finished (60.2%); especially pulmonary events (80.4%). Three out of five deaths and 50.3% of severe TAAEs were pulmonary. In the multivariate analysis surgical patients had half TAAEs risk when compared to medical patients (OR, 0.53; 95% CI, 0.34-0.78) and women had nearly twice the risk of a pulmonary event compared to men (OR, 1.84; 95% CI, 1.03-3.32). Patient\'s age, blood component type, or blood component shelf-life were unrelated to TAAEs risk.
Active hemovigilance programs provide additional data which may lead to better recognition and understanding of TAAEs and their frequency and severity.

Blood transfusion saves millions of lives year around the world; it is the most important life-saving option for blood recipients. However, this act is not without risks as contaminated blood may be the source of transfusion-transmissible infections (TTI). This is a retrospective and comparative study on the prevalence of acquired human immunodeficiency syndrome, viral hepatitis B, C and syphilis in blood donors from Bejaia province (Algeria).
This study is designed to estimate the risk of TTIs among blood donors and the demographic associated factors. It was carried out in the serology laboratories of Bejaia blood transfusion center and Khalil Amrane university hospital. Data were collected from the archived results of screening tests for HBV, HCV, HIV and syphilis, mandatory for all blood donations, from January 2010 to December 2019. The association was considered statistically significant at p < 0.05.
Among 140,168 donors from Bejaia province, 78,123 represent the urban population and 62,045 the rural population. Over 10 years, results of serological tests revealed a prevalence of 0.077%, 0.083%, 0.102%, and 0.132%, respectively for HIV, HCV, HBV, and Treponema pallidum. Trends of hepatitis B and syphilis were decreasing; however, hepatitis C was increasing.
HIV and syphilis prevalence have been variable, with significant peaks in 2013 and 2014, respectively. Globally, the low rates reported in this study confirm the effectiveness of the preventive policy applied by the health authorities. However, among the rural population, special attention is required to stem any resurgence of hepatitis C and syphilis.

OBJECTIVE: Polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is a widely used material for medical transfusion devices. Not covalently bound to PVC, DEHP can migrate into blood products during storage. Recognized as an endocrine disruptor and raising concerns about its potential carcinogenicity and reprotoxicity, DEHP is gradually being withdrawn from the medical device market. Therefore, the use of alternative plasticizers, such as diisononylcyclohexane-1,2-dicarboxylate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT), as potential candidates for the replacement of DEHP in medical transfusion devices has been investigated. The purpose of this study was to evaluate the quantity of PVC-plasticizers in the blood components according to their preparation, storage conditions and in function of the plasticizer.
METHODS: Whole blood was collected, and labile blood products (LBPs) were prepared by the buffy-coat method with a PVC blood bag plasticized either with DEHP, DINCH or DEHT. DINCH and DEHT equivalent concentrations were quantified in LBPs by liquid chromatography-tandem mass spectrometry or coupled with UV and compared to DEHP equivalent concentrations.
RESULTS: The plasticizer equivalent concentration to which a patient is exposed during a transfusion depends on the preparation of LBPs as well as their storage conditions, that is, temperature and storage time. At day 1, for all LBPs, the migration of DEHP is 5.0 and 8.5 times greater than DINCH and DEHT, respectively. At the end of the 49 days storage period, the DEHP equivalent concentration in red blood cells concentrate is statistically higher when compared to DINCH and DEHT, with maximal values of 1.85, 1.13 and 0.86 μg/dm2 /mL, respectively.
CONCLUSIONS: In addition to lower toxicity, transfused patients using PVC-DEHT or PVC-DINCH blood bags are less exposed to plasticizers than using PVC-DEHP bags with a ranging exposure reduction from 38.9% to 87.3%, due to lower leachability into blood components.

Nucleic acid Amplification testing (NAT) has helped improve blood safety and detect window period and Occult Hepatitis B infections (OBI) This study was aimed at determining the following in blood donors: 1. seroprevalence of HIV, HBV & HCV, malarial parasite and Syphlis 2. NAT and seroyield for HIV, HBV and HCV 3. viral load in NAT yield donations 4. Pattern of HBV serological markers in HBV NAT yield donations 80,809 blood donations were screened over an 8 year period (2012-2019) for antiHIV I and II, HBsAg, antiHCV antibodies, malarial parasite and VDRL. Seronegative samples were tested by NAT using a multiplex PCR in a pool of six. NAT yield samples were tested for viral load and HBV serological markers. Seropositive samples were tested for NAT and checked for seroyield. SPSS windows version 24.0 was used for statistical analysis. 1.07% of blood donors were found to be seropositive with 0.08%, 0.86%, 0.09%, 0.03% and 0 for anti HIV I and II, HBsAg, antiHCV, VDRL and Malarial parasite respectively. Out of 79,938 seronegative samples, 20 samples (0.025%) were NAT positive for Hepatitis B with a NAT yield OF 1:3997. Out of the 20 NAT positive samples, 17 were OBI and three were window period infections. 14 NAT yield samples subjected to a HBV viral load assay showed a range of < 6-146 IU/ml. Minipool NAT in pools of six is able to indentify both OBI and window period infections. NAT could significantly improve the blood safety in a resource limited setting like India.

UNASSIGNED: This study aimed to determine the prevalence of blood transfusion-transmitted infections (TTIs), among blood donors in Pakistan, specifically HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, and malaria.
UNASSIGNED: Data records of all registered blood donors (n = 120 968) during 2008-2019, at a blood transfusion center in a tertiary care hospital were assessed. Frequency of the seropositive donors for HIV, HCV, HBV, syphilis, and malaria was analyzed.
UNASSIGNED: The overall age range of the donors was 25-65 years. Nearly all were male (99.0%). HCV, syphilis, and malaria were more prevalent among those aged 26-35 years. Most donors (81.1%) were residents of Islamabad city. The infection with the highest prevalence among the screened blood donors was HCV (1.5%; 95% CI: 0.423-0.661) followed by syphilis (0.8%; 95% CI: 1.149-1.432). HCV and syphilis were most frequently observed in blood group B positive (B+) donors while HIV was more common in those who were O+. The frequency of co-infection of syphilis with HCV and HIV was 0.02% and 0.01%, respectively.
UNASSIGNED: Among male blood donors, the most prevalent TTI infection was HCV followed by HIV; the latter is on the rise. HCV and syphilis are the most frequent co-infections.

The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is a new iteration of prior National Heart, Lung, and Blood Institute (NHLBI) REDS programs that focus on improving transfusion recipient outcomes across the lifespan as well as the safety and availability of the blood supply.
The US program includes blood centers and hospitals (22 including 6 free-standing Children\'s hospitals) in four geographic regions. The Brazilian program has 5 participating hemocenters. A Center for Transfusion Laboratory Studies (CTLS) and a Data Coordinating Center (DCC) support synergistic studies and activities over the 7-year REDS-IV-P program.
The US is building a centralized, vein-to-vein (V2V) database, linking information collected from blood donors, their donations, the resulting manufactured components, and data extracts from hospital electronic medical records of transfused and non-transfused patients. Simultaneously, the Brazilian program is building a donor, donation, and component database. The databases will serve as the backbone for retrospective and prospective observational studies in transfusion epidemiology, transfusion recipient outcomes, blood component quality, and emerging blood safety issues. Special focus will be on preterm infants, patients with sickle cell disease, thalassemia or cancer, and the effect of donor biologic variability and component manufacturing on recipient outcomes. A rapid response capability to emerging safety threats has resulted in timely studies related to Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2).
The REDS-IV-P program endeavors to improve donor-recipient-linked research with a focus on children and special populations while also maintaining the flexibility to address emerging blood safety issues.

BACKGROUND: Transfusion-transmitted infections (TTIs) are a global health challenge. One new approach to reduce TTIs is the use of pathogen reduction technology (PRT). In vitro, Mirasol PRT reduces the infectious load in whole blood (WB) by at least 99%. However, there are limited in vivo data on the safety and efficacy of Mirasol PRT. The objective of the Mirasol Evaluation of Reduction in Infections Trial (MERIT) is to investigate whether Mirasol PRT of WB can prevent seven targeted TTIs (malaria, bacteria, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, hepatitis E virus, and human herpesvirus 8).
METHODS: MERIT is a randomized, double-blinded, controlled clinical trial. Recruitment started in November 2019 and is expected to end in 2024. Consenting participants who require transfusion as medically indicated at three hospitals in Kampala, Uganda, will be randomized to receive either Mirasol-treated WB (n = 1000) or standard WB (n = 1000). TTI testing will be performed on donor units and recipients (pre-transfusion and day 2, day 7, week 4, and week 10 after transfusion). The primary endpoint is the cumulative incidence of one or more targeted TTIs from the Mirasol-treated WB vs. standard WB in a previously negative recipient for the specific TTI that is also detected in the donor unit. Log-binomial regression models will be used to estimate the relative risk reduction of a TTI by 10 weeks associated with Mirasol PRT. The clinical effectiveness of Mirasol WB compared to standard WB products in recipients will also be evaluated.
CONCLUSIONS: Screening infrastructure for TTIs in low-resource settings has gaps, even for major TTIs. PRT presents a fast, potentially cost-effective, and easy-to-use technology to improve blood safety. MERIT is the largest clinical trial designed to evaluate the use of Mirasol PRT for WB. In addition, this trial will provide data on TTIs in Uganda.
BACKGROUND: Mirasol Evaluation of Reduction in Infections Trial (MERIT) NCT03737669 . Registered on 9 November 2018.

OBJECTIVE: This study aims at evaluating whether subjective donor deferral (SDD) has the potential for increasing blood transfusion safety.
BACKGROUND: Appropriate donor selection via clinical and serologic screening is necessary to prevent transfusion-transmissible infections (TTIs). One additional strategy adopted by some Brazilian blood transfusion centers (BTCs) is the rejection of a donation by the pre-donation interviewer based on subjective factors.
METHODS: We conducted a STROBE-guided cross-sectional study including 105 005 prospective donors who presented to our BTC between 1 January 2013, and 31 December 2015. Donors were evaluated for age, gender, education level, donation type and history, confidential unit exclusion, SDD, and results of serologic screening for TTIs.
RESULTS: Even after controlling for potential confounding variables, subjectively deferred donors were more likely to have at least one reactive serology in the standard screening (OR: 2.80; 95% CI: 2.13-3.69; P < .001). They also had a higher risk for testing positive for syphilis (OR: 4.47; 95% CI: 3.05-6.55; P < .001), hepatitis B (OR: 5.69; 95% CI: 2.48-13.08; P < .001), and HIV (OR: 6.14; 95% CI: 3.22-11.69; P < .001).
CONCLUSIONS: Routine implementation of SDD in donor selection may be an effective additional measure to avoid TTIs, highlighting the importance of interviewer experience, perspicacity, and face-to-face contact with donors for blood safety assurance.