How do we achieve blinding in modern electronic and paper medical records during the conduct of transfusion trials?

BACKGROUND: Regulatory aspects of transfusion medicine add complexity in blinded transfusion trials when considering various electronic record keeping software and blood administration processes. The aim of this study is to explore strategies when blinding transfusion components and products in paper and electronic medical records. METHODS: Surveys were collected and interviews were conducted for 18 sites across various jurisdictions in North America to determine solutions applied in previous transfusion randomized control trials. RESULTS: Sixteen responses were collected of which 11 had previously participated in a transfusion randomized control trial. Various solutions were reported which were specific to the laboratory information system (LIS) and electronic medical record (EMR) combinations although solutions could be grouped into four categories which included the creation of a study product code in the LIS, preventing the transmission of data from the LIS to the EMR, utilizing specialized stickers and labels to conceal product containers and documents in the paper records, and modified bedside procedures and documentation. DISCUSSION: LIS and EMR combinations varied across sites, so it was not possible to determine combination-specific solutions. The study was able to highlight solutions that may be emphasized in future iterations of LIS and EMR software as well as procedural changes that may minimize the risk of unblinding.

The estimated negative impacts on the red blood cell inventory of reducing shelf-life at two large health authorities in British Columbia, Canada, using a discrete-event simulation model.

BACKGROUND AND OBJECTIVES: Reducing the maximum red blood cell (RBC) shelf-life is under consideration due to potential negative effects of older blood. An assessment of the impacts of this change on blood supply chain management is evaluated. MATERIALS AND METHODS: We performed a simulation study using data from 2017 to 2018 to estimate the outdate rate (ODR), STAT order and non-group-specific RBC transfusion at two Canadian health authorities (HAs). RESULTS: Shortening shelf-life from 42 to 35 and 28 days led to the following: ODRs (in percentage) in both HAs increased from 0.52% (95% confidence interval [CI] 0.50-0.54) to 1.32% (95% CI 1.26-1.38) and 5.47% (95% CI 5.34-5.60), respectively (p < 0.05). The estimated yearly median of outdated RBCs increased from 220 (interquartile range [IQR] 199-242) to 549 (IQR 530-576) and 2422 (IQR 2308-2470), respectively (p < 0.05). The median number of outdated redistributed units increased from 152 (IQR 136-168) to 356 (IQR 331-369) and 1644 (IQR 1591-1741), respectively (p < 0.05). The majority of outdated RBC units were from redistributed units rather than units ordered from the blood supplier. The estimated weekly mean STAT orders increased from 11.4 (95% CI 11.2-11.5) to 14.1 (95% CI 13.1-14.3) and 20.9 (95% CI 20.6-21.1), respectively (p < 0.001). The non-group-specific RBC transfusion rate increased from 4.7% (95% CI 4.6-4.8) to 8.1% (95% CI 7.9-8.3) and 15.6% (95% CI 15.3-16.4), respectively (p < 0.001). Changes in ordering schedules, decreased inventory levels and fresher blood received simulated minimally mitigated these impacts. CONCLUSION: Decreasing RBC shelf-life negatively impacted RBC inventory management, including increasing RBC outdating and STAT orders, which supply modifications minimally mitigate.

Evaluation of immunoglobulin replacement therapy in secondary immunodeficiency at three British Columbia hospitals.

BACKGROUND AND OBJECTIVES: Immunoglobulin (Ig) usage has ongoing shortage concerns. Secondary immunodeficiencies (SIDs) account for a major proportion of usage of Igs in Canada. We audited Ig usage in patients with SID at three British Columbia hospitals to determine whether more stringent local guidelines are necessary. MATERIALS AND METHODS: A retrospective chart review was performed for patients who had Ig ordered between 1 January 2018 and 31 December 2019 for any SID indication. Cohorts were stratified into chronic and new users, and the Australian BloodSTAR guidelines were used as the benchmark at the time of conception. Having an eligible primary diagnosis, meeting SID criteria, an appropriate dosage and follow-up immunoglobulin G (IgG) levels encompassed appropriate usage. RESULTS: There were no demographic differences between chronic (N = 81) and new (N = 33) cohorts. The new cohort had a higher rate of appropriate usage (45.7% vs. 66.7%, p = 0.06). The most common reason for inappropriate usage in both groups was the lack of follow-up IgG level at 6 or 12 months. Factors, displayed by relative risk (RR), associated with appropriateness included the dispensing hospital (RR: 6.60), use of subcutaneous Ig (RR: 3.84), having an IgG level before starting therapy (RR: 3.51) and documentation of clinical benefit (RR: 4.70). CONCLUSION: There are high rates of inappropriate Ig usage in SID patients in both new and chronically treated groups. More stringent local guidelines and processes for assessing initial and ongoing Ig replacement are warranted.

Adaptations of transfusion systems to the COVID-19 pandemic in British Columbia, Canada: Early experiences of a large tertiary care center and survey of provincial activities.

BACKGROUND: In March 2020, a state of emergency was declared to facilitate organized responses to the coronavirus disease 2019 (COVID-19) pandemic in British Columbia, Canada. Emergency blood management committees (EBMCs) were formed regionally and provincially to coordinate transfusion service activities and responses to possible national blood shortages. STUDY DESIGN AND METHODS: We describe the responses of transfusion services to COVID-19 in regional health authorities in British Columbia through a collaborative survey, contingency planning meeting minutes, and policy documents, including early trends observed in blood product usage. RESULTS: Early strategic response policies were developed locally in collaboration with members of the provincial EBMC and focused on three key areas: utilization management strategies, stakeholder engagement (collaboration with frequent users of the transfusion service, advance notification of potential inventory shortage plans, and development of blood triage guidance documents), and laboratory staffing and infection control procedures. Reductions in transfusion volumes were observed beginning in mid-March 2020 for red blood cells and platelets relative to the prepandemic baseline (27% and 26% from the preceding year, respectively). There was a slow gradual return toward baseline beginning one month later; no product shortage issues were experienced. CONCLUSION: Provincial collaborative efforts facilitated the development of initiatives focused on minimizing potential COVID-19-related disruptions in transfusion services in British Columbia. While there have been no supply issues to date, the framework developed early in the pandemic should facilitate timely responses to possible disruptions in future waves of infection.

Two cases of the variant RHD*DAU5 allele associated with maternal alloanti-D.

CONCLUSIONS: Rh is a complex blood group system with diverse genotypes that may encode weak and partial D variants. Standard serologic analysis may identify clinically significant D variants as D+; nevertheless, individuals with these D variants should be managed as D- patients to prevent antibody formation to absent D epitopes. Variant identification is necessary during pregnancy to allow for timely and appropriate Rh immune globulin (RhIG) prophylaxis for hemolytic disease of the fetus and newborn (HDFN) as D alloimmunization can occur with some D variants. Here, we describe two cases of the RHD*DAU5 allele associated with maternal alloanti-D in patients of African ancestry. Two obstetric patients were initially serologically classified as D+ with negative antibody detection tests on routine prenatal testing. Repeat testing at delivery identified anti-D in both patients with no history of RhIG administration or transfusion. DNA sequencing revealed that both patients possessed the RHD*DAU5 allele. Cord blood testing on both infants revealed positive direct antiglobulin test (DAT) results with anti-D eluted from the red blood cells (RBCs) of one of the infants. Despite the positive DAT, neither infant experienced anemia or hyperbilirubinemia. We document two cases of pregnant women whose RBCs expressed a partial D variant and were classified as D+ on the basis of standard serologic testing, resulting in subsequent failure to provide RhIG prophylaxis. Both cases were associated with alloanti-D formation but without significant HDFN. To our knowledge, these are the first reported cases of maternal alloanti-D associated with the RHD*DAU5 partial D variant.