Understanding the demand for phenotyped red blood cell units and requests to perform molecular red blood cell typing for Australian patients.

BACKGROUND: Australian Red Cross Lifeblood has seen a 50 % increase in demand for phenotyped red blood cell (RBC) units between 2016-2018 and a 30 % increase in demand in 2018 to perform molecular RBC typing on patient samples. Lifeblood conducted a survey to understand transfusion laboratory practices for requesting patient phenotyping and/or molecular RBC typing and for selecting phenotyped RBC units in various patient groups. STUDY DESIGN AND METHODS: An electronic Qualtrics survey form was sent to 296 transfusion laboratories with questions designed to understand the practice of selecting phenotyped RBC units and reasons for requesting extended serology or molecular RBC typing. RESULTS: 49 (16.6 %) transfusion laboratories provided data. Reasons to request extended phenotyping and/or molecular RBC typing for patients included; chronic transfusion (n = 31 laboratories), sickle cell disease (n = 25), Thalassemia (n = 23), requirement for anti-CD38 or other MAB therapy (n = 23) or Myelodysplasia (n = 22). Forty-seven transfusion laboratories provided responses with reasons for requesting molecular RBC typing which included: predicting phenotype in patients with multiple antibodies (n = 31), prior to administering anti-CD38 or other MAB therapies (n = 29), for pregnancy related transfusions (n = 28) or for confirming the phenotype of recently transfused patients (n = 18). CONCLUSION: Transfusion laboratory practices indicated that phenotyped RBC units were selected for patients requiring chronic transfusion support and/or undergoing MAB therapy. Requests for molecular RBC typing occurred for more complex patient requirements where serological investigations were not suitable or possible due to reagent restrictions.

Evaluation of a tool to score donor vein suitability for blood donation.

BACKGROUND AND OBJECTIVES: Phlebotomy is a central task for whole blood donation, yet there are no published standards regarding systematic donor vein assessment or the impact of vein quality on successful blood donation. Blood donation failures and related adverse events are highly predictive of donors not returning for future blood donation. A specific blood donation vein scoring tool was assessed to measure donor vein suitability for whole blood collection and investigate the correlation of the donor's veins with donation outcomes. MATERIALS AND METHODS: The vein assessment tool consisted of three questions using a 5-point Likert-type scale to measure responses. Two phlebotomists performed blinded assessments of each donor's veins on each arm using the tool. The individual measures were then aggregated to provide a total vein score out of 12. Inter-rater reliability of the vein score tool was assessed by calculating the intraclass correlation coefficient for absolute agreement. RESULTS: Fifty-seven phlebotomists across four fixed blood donation centres performed paired vein assessments on 553 blood donors. The intraclass correlation coefficient indicated moderate inter-rater reliability was achieved. The median scores for viable donations were 10, for non-viable donations were 6·5 and for failed phlebotomies were 4. Donation histories of donors with lower vein scores indicated lower success during blood donation. CONCLUSION: The vein score tool appears to be predictive of a successful donation outcome, however, since there was not a suitably high correlation between the scores of the two assessors, further refinement of the tool will be required prior to wider use.

An analysis on the fate of a selection of blood products derived from cytomegalovirus-seronegative donors at three tertiary referral hospitals in Australia.

BACKGROUND: Supply of cytomegalovirus (CMV)-seronegative blood products in Australia is an ongoing challenge. Requests for CMV-negative products are increasing with prediction that the demand will exceed supply by 2019. Clinical information evaluating how these products are being utilized by health providers within Australia is limited. This study aimed to identify indications for use of CMV-negative blood products and gather data to support possible practice change. STUDY DESIGN AND METHODS: All CMV-negative products issued to three tertiary Australian hospitals from May 1, 2016, to May 31, 2016, were identified (n = 1219). This equated to 1044 red blood cell units and 175 platelet units. Data were collected on the fate of each unit. Information collected included the indication and urgency of transfusion, reason for discard, product age, and recipient CMV immunoglobulin G status. RESULTS: Of the units issued during the audit period, 32 (2.6%) were discarded by the hospitals. Transfusion data were collected on 411 units. Of these, 136 (33.1%) were transfused to CMV-positive recipients, in most cases for hematology indications, and 67 units (16.3%) were transfused to CMV-negative requiring recipients. A total of 144 (35%) CMV-negative units were selected based on their irradiation status. Other reasons for the selection of CMV-negative units included product close to expiry (n = 134, 32.6%) or specific patient phenotype requirements (n = 31, 7.5%). CONCLUSION: In this study, the majority of CMV-negative blood products were not used for CMV-negative requiring recipients. Alterations to inventory management would be advantageous to ensure continued supply for CMV-negative requiring recipients.

The use of historical platelet counts from blood donors to program apheresis platelet donation: An Australian perspective.

BACKGROUND: For Australian apheresis platelet donations, in-centre haematology analysers provided the platelet count used to program the platelet collection machines. When the haematology analysers were not functional, historical platelet counts from previous donations were used. This study aimed to confirm that the routine use of historical platelet counts for programming apheresis collection machines would maintain platelet yields within the donated units and that haematology analysers could be removed. STUDY DESIGN: A staggered implementation for the routine use of mean historical platelet counts to program apheresis platelet collection machines was conducted. The donors' full blood counts following donation were tested centrally for comparison to the historical mean. The component yields when using on-the-day platelet counts to program platelet collection were compared with those collected using historical platelet counts. For historical platelet counts to be deemed successful, the target was for 90% of the mean historical donor platelet counts to have less than 20% variance from the on-the-day platelet count. RESULTS: Over 96% of the mean historical platelet counts were within 20% variance of the platelet count on the day of donation. The component yield (platelet count x109 cell/unit) before analyser removal was 273.3 ±â€¯32.0 (n = 2639) and post-removal was 282.8 ±â€¯38.8 (n = 2689). CONCLUSION: The removal of haematology analysers from donor centres and replacement with mean historical platelet counts was successful in maintaining platelet yields. Replacement of the haematology analysers with historical platelet counts simplified regulatory compliance, reduced staff workload and costs associated with analyser registration.

A national review of the clinical use of group O D- red blood cell units.

BACKGROUND: There has been an international decline in the demand for red blood cell (RBC) units. In Australia, there has been a 21% reduction in demand between 2012 and 2015. In contrast, the demand for the "universal" group O D- RBC units is in fact proportionally increasing. STUDY DESIGN AND METHODS: The clinical use of the entire O D- RBC distribution for a 5-week period throughout Australia was reviewed. Fate data on each unit issued (n = 9733) were collected that included the indication and urgency of transfusion, reason for discard, component age, and patient demographics. RESULTS: A total of 74% of audit forms were returned (n = 7143). The national discard rate of issued units was 7.9%. A total of 6387 units were transfused into an estimated total of 3008 patients (55% males) with median patient age of 67 years and median RBC age of 21 days. Forty-seven percent were transfused to group O D- patients. A total of 17.4% were chosen for specific phenotype requirements, 24.5% of units were transfused close to expiry, and 24.5% were transfused into patients of other ABO groups. CONCLUSION: The data appear broadly representative of the current transfusion and inventory management practices surrounding the use of group O D- RBC units. Strategies to reduce O D RBC demand include reevaluation of inventory holdings particularly at smaller centers, increasing the panel of phenotyped RBC units across all ABO groups, more regular rotation of units between hospitals to minimize time expiry, and continuing education for promoting transfusion of ABO-identical RBC units.

Serum eye drop preparation in Australia: Current manufacturing practice.

Serum eye drops are used to treat diseases such as dry eye syndrome (keratoconjunctivitis sicca), a disease of the surface of the eye that results in an unstable tear film. Patients are referred to the Australian Red Cross Blood Service by ophthalmologists for autologous serum eye drops when other therapies such as artificial tears or topical immunosuppressive agents have failed. In order to manufacture autologous serum eye drops, whole blood is collected from the patients using standard blood collection procedures. The blood is then allowed to clot to produce serum and processed into 20% serum eye drops, which are then returned to the patient for their own use. The eye drops are packaged into a long length of tubing, which is then heat-sealed to produce single-use segments. The demand for serum eye drops in Australia is increasing every year, with a 30% increase in the past 12 months.

Sustained benefits of autologous serum eye drops on self-reported ocular symptoms and vision-related quality of life in Australian patients with dry eye and corneal epithelial defects.

BACKGROUND: This research examined the effect of autologous serum eye drops (ASED) on ocular symptoms, visual-related functioning and quality of life for patients failing other therapies. METHODS: Patients (N = 77) were asked to complete a survey prior to ASED use, and 2 and 12 months post-treatment. RESULTS: Significant improvements in symptom frequency and severity were documented for dryness, ocular pain and grittiness at 2 and 12 months. Patients felt more in control and required less help from others at 12 months. CONCLUSIONS: ASED produce sustained benefits to dry eye symptoms, improve feelings of control and reduce requirements for assistance from others.

An 8-week course of 45 mg of carbonyl iron daily reduces iron deficiency in female whole blood donors aged 18 to 45 years: results of a prospective randomized controlled trial.

BACKGROUND: Blood donation is known to contribute to iron deficiency in regular blood donors. This study investigated the safety and efficacy of postdonation iron replacement to mitigate iron deficiency in blood donors. STUDY DESIGN AND METHODS: A total of 282 female whole blood donors aged 18 to 45 were prospectively randomized in a double-blinded placebo controlled trial to receive an 8-week postdonation course of carbonyl iron (45 mg daily) or placebo. The primary endpoint was prevalence of iron deficiency (ferritin < 15 ng/mL) at 12 weeks postdonation. Secondary endpoints were eligibility to donate based on capillary hemoglobin (Hb) and incidence of gastrointestinal (GI) complaints. RESULTS: Ferritin levels at Week 12 were significantly higher in donors receiving carbonyl iron (17.0 ± 10.9 ng/mL) compared with those receiving placebo (10.6 ± 8.4 ng/mL; p < 0.001). The proportion of iron-deficient donors was significantly lower in the carbonyl iron group (51.9%) compared to the placebo (80.5%; p < 0.001). The mean Hb level in the carbonyl iron group (134.6 ± 8.7 g/L) was significantly higher than in the placebo arm (130.0 ± 9.9 g/L; p < 0.001), significantly improving eligibility to donate at Week 12. Significantly more donors receiving carbonyl iron had at least one GI side effect (p < 0.001). Importantly, 86.7% of donors receiving carbonyl iron indicated that they would take iron on an ongoing basis. CONCLUSION: An 8-week postdonation course of 45 mg of carbonyl iron significantly reduced iron deficiency and was well tolerated in female whole blood donors. Postdonation iron replacement may have a role in a broader strategy to optimize donor iron status.

The prevalence of selected clinically significant red blood cell antigens among Australian blood donors.

Red blood cell (RBC) transfusion can cause some patients to form antibodies to RBC antigens when RBC phenotypes do not match that of the blood donor. Transfusion practitioners can order phenotyped RBC units for patients with known RBC antibodies or those who are at risk of forming them. However, with increasing demand for phenotyped RBC units, contemporary data on antigen prevalence is required to manage the changing supply. A total of 490,491 blood donors, including 103,798 (21.2%) first-time blood donors, from 2019 were analysed for the prevalence of selected clinically relevant blood group antigens. Prevalence of the phenotype R1R1 (D+ C+ E- c- e+) increased from the previous estimate of 17.3% to 24.0% in first-time blood donors. The prevalence of R1r (D+ C+ E- c+ e+) decreased from 35.3% to 30.8%. R1R1 was more common in blood donors born in Asia or the Middle East. The prevalence of Fy(a-b-) in donors where Fy antigens were tested was 0.2%. Of these, 71.8% stated their region of birth as Africa. The prevalence of Jk(a-b-) is 0.01% in donors where the Jk antigens were tested with region of birth stated as either Oceania or Asia. The increasing prevalence of the c-negative phenotype in R1R1 individuals is associated with the changing demographics of the Australian community. For R1R1 individuals with childbearing potential, the transfusion of RhD negative blood, which is usually c-positive, may increase the possibility of haemolytic disease of the fetus and newborn during pregnancy. Continued diversification of the Australian blood donor panel will support having the appropriate phenotyped RBC units available.

Patient-reported outcomes of serum eye drops manufactured from Australian blood donations and packaged using Meise vials.

Introduction: Serum eye drops (SED) are an effective treatment for dry eye syndrome. However, autologous serum collection can have challenges. Patient-tailored (allogeneic) SED (PT-SED) can be made from healthy blood donors. Australian Red Cross Lifeblood has manufactured both autologous SED (Auto-SED) and PT-SED and, in May 2021, introduced Meise vial packaging. This study aimed to explore SED patient-reported outcomes and vial packaging satisfaction. Methods: A prospective cohort study was conducted with recruitment between 1 November 2021 and 30 June 2022. Participants completed the dry eye questionnaire (DEQ5), health-related quality-of-life (SF-8™), functional assessment of chronic illness therapy-treatment satisfaction-general (FACIT-TS-G), and general wellbeing surveys. Existing patients completed these once, and new patients were surveyed at baseline, 3 months post-treatment, and 6 months post-treatment. Results: Participants who completed all study requirements were 24 existing and 40 new Auto-SED and 10 existing and 8 new PT-SED patients. Auto-SED patients were younger [56.2 (±14.7) years] than PT-SED patients [71.4 (±10.0) years]. Participants used a mean of 1.8 (±1.1) SED, 5.3 (±2.9) times per day. In new patients, DEQ5 scores improved within 6 months from 14.0 (±2.9) to 10.6 (±3.4) for Auto-SED and from 12.9 (±3.7) to 11.4 (±2.8) for PT-SED. General wellbeing measures improved in the new Auto-SED from 7.0 (±1.9) to 7.8 (±1.7) but were reduced for new PT-SED from 6.7 (±2.9) to 6.1 (±2.9). Discussion: SED improved dry eye symptoms in most patients, regardless of the serum source. Patients using PT-SED showed decreases in some quality-of-life measures; however, recruitment was reduced due to operational constraints, and concurrent comorbidities were not assessed. General feedback for SED and vial packaging was positive, with some improvements identified.

Review of full blood count reference interval using a large cohort of first-time plasmapheresis blood donors.

Full blood counts (FBC) are routinely performed on blood donors donating by apheresis. Australian Red Cross Lifeblood (Lifeblood) historically set FBC reference intervals (RIs) in alignment with standards of the Royal College of Pathologists of Australasia (RCPA). Recommendations now advise that RIs be developed locally to represent the population. This study analysed new blood donors' FBC results to inform a review of the current Lifeblood RIs. Retrospective analysis of routine laboratory data for first-time direct to plasmapheresis donations from 1 July 2018 to 30 June 2019 was conducted (n=15,710). FBC were performed using DxH 800 Haematology analysers. The 2.5% and 97.5% percentiles were compared with the current RIs and clinically significant variation informed adjustment. White blood cell and platelet parameters remained in alignment with RCPA reference intervals. The haemoglobin (Hb) RI for female donors reduced from 115-165 g/L to 113-147 g/L. For male donors, the upper limit for Hb required reduction from 185 g/L to 165 g/L. Red blood cell (RBC) counts and haematocrit (HCT) levels were lowered in this derivation from blood donors. Appropriate RIs allow for both the early detection of disease and avoid unnecessary investigation of otherwise healthy people. FBC analysis from current blood donors indicated changes were required to the RIs. The adjusted lower RBC and HCT values reduces the proportion of donors considered to have abnormal findings. The lower Hb limits will remain at 115 g/L in females and 125 g/L in males to align with regulatory requirements for blood donation.

Immunomodulation of inflammatory leukocyte markers during intravenous immunoglobulin treatment associated with clinical efficacy in chronic inflammatory demyelinating polyradiculoneuropathy.

OBJECTIVE: The objective of the study was to profile leukocyte markers modulated during intravenous immunoglobulin (IVIg) treatment, and to identify markers and immune pathways associated with clinical efficacy of IVIg for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) with potential for monitoring treatment efficacy. METHODS: Response to IVIg treatment in newly diagnosed IVIg-naïve and established IVIg-experienced patients was assessed by changes in expression of inflammatory leukocyte markers by flow cytometry. The adjusted INCAT disability and Medical Research Council sum scores defined clinical response. RESULTS: Intravenous immunoglobulin modulated immunopathogenic pathways associated with inflammatory disease in CIDP. Leukocyte markers of clinical efficacy included reduced CD185+ follicular helper T cells, increased regulatory markers (CD23 and CD72) on B cells, and reduction in the circulating inflammatory CD16+ myeloid dendritic cell (mDC) population and concomitant increase in CD62L and CD195 defining a less inflammatory lymphoid homing mDC phenotype. A decline in inflammatory CD16+ dendritic cells was associated with clinical improvement or stability, and correlated with magnitude of improvement in neurological assessment scores, but did not predict relapse. IVIg also induced a nonspecific improvement in regulatory and reduced inflammatory markers not associated with clinical response. CONCLUSIONS: Clinically effective IVIg modulated inflammatory and regulatory pathways associated with ongoing control or resolution of CIDP disease. Some of these markers have potential for monitoring outcome.