The development and evaluation of options for improving future U.K. blood component labelling--outcome of the 2013 U.K. hospital survey.

BACKGROUND/OBJECTIVES: U.K. blood component labels have evolved to accommodate a plethora of information. Concern has, however, been expressed that current U.K. labelling is too 'cluttered', detracting from the clarity of critical information. This prompted a holistic review of labelling and available information technology (IT) with the aim of improving the situation. METHODS/MATERIALS: A survey was circulated requiring U.K. hospital participants to rank each item of information on the label according to its 'criticality' and assess three novel 'future' and one 'transition' prototype labels. Prototypes were based on applicable regulatory standards, best practice guidance, international benchmark data and U.K. expert input. The prototypes support steps towards 'full face' label printing and utilise 2D and quick response (QR) barcodes. RESULTS: Two-hundred eleven completed surveys were received identifying 110 contributing hospitals with 41% from clinical staff, 37% from transfusion laboratory staff and 22% from transfusion practitioners. There was excellent agreement between the three groups on the critical information, i.e., blood group, expiry date, blood component name, unique donation identification number (DIN) and blood component volume but far less on the other information, especially the various warning messages. Of the 'future' labels, option 3 (closest to the current 'quadrant model') was most popular. Option 1, with its additional inverted section replicating critical information was least popular and prompted significant safety concerns. CONCLUSION: The prototype labels correctly identified the critical items of information and extensive comments confirmed that this was more prominently and clearly displayed. Laboratory staff commented that the transition label was essential to enable IT systems to be adapted.

Ensuring that blood transfusion sets administer an effective dose of functional blood components.

BACKGROUND: Proposed changes to ISO 1135-4 will require that blood transfusion administration sets are demonstrated by the manufacturers to be suitable for the range of cellular and plasma blood components for which they are designated. AIMS: To design a test protocol to asses the depletion of the blood components by transfusion sets and damage and activation of blood components during their passage through the set. METHODS: Transfusion giving sets (CareFusion Ref no. 60895 180311 and Fresenius Ref no. 2900032) were assessed by comparing samples of the blood component taken prior to and after passage through the transfusion set in strict accordance with the manufacturer's instructions. As well as depletion of red cells, platelets and FVIIIc, the following markers of damage/activation were assessed: red cells-supernatant haemolysis and potassium; FFP-prothrombin fragments 1 and 2 and fibrinopeptide A and platelets-pH, CD62P, CD63 and sP-selectin. RESULTS: The CareFusion and the Fresenius transfusion sets gave less than 5% depletion of blood components and caused negligible and clinically insignificant effects on red cells, platelet concentrates and FFP. CONCLUSION: A practical test protocol has been established to assess the depletion, damage to and activation of the key constituents of commonly requested blood components. This protocol would provide a valuable addition to ISO 1135-4 in assuring the suitability of transfusion sets.

The donor line break cannula: effect on the donation process, blood component quality and transfusion microbiology testing of an important new blood bag safety feature.

BACKGROUND: The use of blood packs with an integral sampling system can result in anti-coagulant from the main bag reaching the sample pouch via the donor line, causing delayed coagulation of blood samples. In NHS Blood and Transplant, this has prevented the use of serum, the preferred matrix for transfusion microbiology (TM) testing, which has led to an increased false positive rate with ethylenediaminetetraacetic acid (EDTA) plasma. There is also a remote possibility of false negative results owing to sample dilution. Manufacturers have responded by offering packs with a donor line break cannula (DLBC) to prevent these adverse effects. OBJECTIVES: The aims of this study were to assess the impact of DLBC packs on donation, blood component quality and of the potential return to serum for TM testing. METHODS: DLBC packs from three manufacturers were assessed against control packs of the same dimensions and configuration. Donation duration, flow rate, platelet factor 4, prothrombin fragment 1+2, haemolysis and collection and processing incidents were compared. RESULTS: Results indicated no clinically significant adverse effect from the DLBC on the activation state of platelets, the coagulation cascade or increased haemolysis. Donation duration and blood collection and processing incident rates for DLBC packs were not significantly different to controls. CONCLUSIONS: The use of DLBC packs would reduce the complexity of manipulations during blood collection and therefore the likelihood of microbially contaminated donations (incorrect skin core diversion) and false negative TM tests. DLBC packs would enable the use of serum for TM testing with a significant reduction in false positive tests compared to EDTA plasma.

An evaluation of statistical process control techniques applied to blood component quality monitoring with particular reference to CUSUM.

BACKGROUND: Statistical process control (SPC) is used to monitor the performance of blood component collection and production processes in the UK and elsewhere. The sensitivity of the applied technique(s) needs to be matched to the clinical importance of the parameter being monitored such that significant deviations in the process mean and/or variability of critical parameters (e.g. the leucocyte content of leucodepleted components) are detected and investigated immediately. AIMS: This study assessed the sensitivity and specificity of a range of techniques for variable and attribute (proportion non-conforming) data. MATERIALS AND METHODS: Comparison was based on a range of simulated and 'live' blood component quality monitoring data including X/R, cumulative sum (CUSUM) procedures, the scan statistic and np charts. RESULTS: X/R and CUSUM could detect shifts of two standard deviations in the process mean within 5 days. Current leucocyte count data (substantially skewed even after log transformation) was found to be better suited to attribute analysis. CUSUM alone was able to detect shifts on the same day when based on 20 or more samples and achieved acceptable specificity. CONCLUSIONS: CUSUM procedures for proportion non-conforming can usefully augment existing X/R techniques for leucodepletion monitoring, provide valid control limits and the required sensitivity. The scan statistic and 'np' charts offered no obvious advantages.

Eurobloodpack: a common European design for blood bag systems with integral leucodepletion filters.

Three EBA specified blood bag configurations ('Eurobloodpack') are described which are capable of meeting >80% of its member's requirements. These include a 'top-and-top' and two 'bottom-and-top' packs enabling aseptic, pre-donation collection of up to 40 ml of samples, 427.5-522.5 ml of whole blood and the preparation of an extensive range of blood components. Features currently beyond the scope of ISO standardisation have been controlled including: anticoagulant and additive volumes; collection needle and sampling system; transfer tubing; cross-match line; base label; leucodepletion filter performance; compatibility of access ports and transfusion sets. Eurobloodpack has significant advantages for blood services and blood bag manufacturers.

Current uses of transfusion administration sets: a cause for concern?

There is potential for inappropriate use of transfusion administration sets when used in combination with modern infusion pumps with consequences for patient safety. The aims of our study were to (i) establish if the design and testing of transfusion sets specified in International Standard ISO 1135-4 are adequate for their current applications, (ii) identify if infusion pumps currently supplied in the UK for blood component administration are suitable for this purpose and (iii) determine the additional control measures needed to be applied by manufacturers and users to ensure patient safety. Keyword literature search was carried out to review and correlate important transfusion parameters with resultant adverse effects. Units for occlusion pressure, flow rate and haemolysis were standardised for ease of comparison. A sample of transfusion set instructions for use was reviewed. Principal suppliers of infusion pumps to the UK market were surveyed to identify those sold for blood transfusion, their recommended operating parameters and compatible transfusion sets. Previous work showed clinically unacceptable haemolysis at pressures above 40 kPa. Modern infusion pumps operate under negative pressures of up to 210 kPa. ISO 1135-4 design and test requirements do not match this performance and in particular omit testing under negative pressure. Transfusion sets surveyed did not indicate flow or pressure restrictions or specify the blood components with which they had been validated. ISO 1135-4 requires updating and has been initiated. Meanwhile, recommendations are made for transfusion set manufacturers concerning pressure limitations and restrictions on blood component type and for users concerning purchase, configuration and validation of infusion pumps and disposables.

Practical guidelines for applying statistical process control to blood component production.

Legislation, guidelines and recommendations for blood components related to statistical process control (SPC) and the selection of a quality monitoring (QM) sampling regimen are subject to misinterpretation and lack practical guidance on implementation. The aim of this article is: to review and interpret applicable European legislation and guidelines and to develop an SPC strategy that meets these requirements; and to provide practical guidance on the selection and application of appropriate techniques and the interpretation of resultant blood component QM data. A methodology is presented which utilizes: an algorithm to select an appropriate quality-monitoring strategy for the blood component parameter under consideration; a range of straightforward, validated SPC techniques for variable data and an assessment of process capability (Cpk) and blood component parameter 'criticality' to determine the sampling regimen. The methodology was applied to routine National Health Service Blood and Transplant (NHSBT) blood component data for 2005-2006. Cpk values ranged from 0.22 to >3 and their predicted non-conformance rates were close to those observed (23 to <0.001%). Required sample size ranged from 0.01 to 10%. Chosen techniques identified significant deviation from 'as validated' performance within an appropriate time-scale. Thus the methodology was straightforward to apply and prompted the choice of a clinically and operationally appropriate sampling regimen and analysis for each blood component parameter. This evidence-based, targeted use of SPC for blood component monitoring provides an essential focus on processes with a low capability in achieving their specifications.

An evaluation of proposed changes to International Standards for blood bags and transfusion sets to improve their compatibility.

Difficulties arising from the poor compatibility of some blood bag and transfusion set combinations remain a significant, ongoing patient safety issue. Proposed changes to international standards based on previously published findings provide a potential resolution when adopted by manufacturers. The aims and objectives of this study were to demonstrate that changes to ISO 3826-1 and 1135-4, especially surface treatment of the transfusion set spike (siliconisation) to reduce insertion force and accidental spiking will not result in: 'Pre-piercing' of the port membrane; difficulty in inserting the spike; leakage from the spike/port connection or unintentional removal of the spike during transfusion. The performance of connections (ports from five and siliconized spikes from two manufacturers) was assessed by a range of physical tests including: pressure tests for leakage at 50 kPa (1.5 bar); static stress (pull) tests at 15 and 20 N. Spike insertion force tests were repeated to challenge original findings. Of the 280 connections tested, there was one dubious pressure tests fail (<10 microL), no pull test failures at 15 N and one at 20 N. Spike insertion forces were acceptable and consistently low with ports from all manufacturers. Findings confirm the benefits of siliconized spikes in improving compatibility between transfusion sets and blood bags. This study does not indicate that the evaluated spikes would be subject to unintentional removal or leakage when used in accordance with manufacturer's instructions. Pressure and pull tests on spike/port connections are a valuable addition to ISO 3826-1 and 1135-4 for manufacturing design validation and quality control purposes.

Care management of work injuries: results of a 1-year pilot outcome assurance program.

A 1-year pilot study was conducted, linking the efforts of a workers' compensation managed care organization with those of an occupational health clinic and emergency department of manage work-related injuries and associated work disability. Sustained (> 90 day), injury-specific return-to-work outcomes, modified by job title, were compared with loosely managed and well-managed benchmarks. The mean return-to-work outcome, measured as lost workdays (LWDs), was 5.11 +/- 21.0 LWDs for 418 workers. These results exceeded benchmarks for both loosely managed care, 14.0 +/- 17.2 LWDs, P < 0.001 (8.9 fewer LWDs/case), and optimally case-managed care, 6.99 +/- 7.64 LWDs, P = 0.044 (1.9 fewer LWDs/case). An estimate of the value of these saved LWDs to the employers-at $200 per workday was $740,400 for the loosely managed benchmarks and $157,000 for the well-managed benchmarks. The Outcome Assurance Program virtually eliminated typical delays in the diagnosis and medical management of these injured workers.

The systematic monitoring of transfusion microbiology test kit performance.

The Transfusion Microbiology Test Systems Monitoring Group (TMTSMG) was established as a National Blood Service (NBS) working group to monitor the performance of the microbiology screening assays used within the NBS Testing Laboratories. The group's primary objective was to ensure that technical performance (especially sensitivity, specificity and wastage) remains consistent with that established during validation. This includes the identification and investigation of significant variation in performance and any untoward incidents. The group is also responsible for optimizing transfusion microbiology working practice across the NBS through nationally agreed standards and procedures. Over the past 9 years, a total of 44 assays from 15 suppliers have been monitored. Five assays have been withdrawn from use as a result of identified poor performance; two hepatitis B virus surface antigen assays owing to poor sensitivity, two syphilis agglutination assays with nonspecific (false) reactive rates sustained above contract limits and one human cytomegalovirus antibody assay that persistently failed the manufacturer's quality control criteria. This approach has enabled the differentiation of genuine kit performance issues from 'natural variation' in kit performance, and local instrumentation or training issues. The NBS has been able to address the issues with suppliers much earlier and resolve minor issues before they became major problems. In addition, a lot release system has been developed and implemented, comprising a formal, centralized initial scientific assessment of each new manufacturer's lot, followed by 'delivery acceptance' testing at each site. This system helps to ensure that the evaluated minimum sensitivity and specificity of the assays is maintained from 'lot to lot'.

Improving compatibility between blood packs and transfusion sets.

Significant variation between manufacturers exists in the force required to insert transfusion set spikes (closure-piercing device) into blood pack ports. This potential source of difficulty can impact directly on patient and staff safety (delayed transfusion, contamination of blood components, wastage, blood spillage and staff injury) and is not predicted or prevented by conformance of these medical devices to relevant International Organization for Standardization (ISO) standards. A quantitative, objective measurement of insertion force is described together with an assessment of factors affecting compatibility between the port and spike. Several advantageous and disadvantageous design features are identified and are being addressed through ISO Technical Committee 76 Work Group 1.

Use of a (proposed) standard protocol to validate Terumo TSCD-II connections between dissimilar blood bag tubing.

BACKGROUND AND OBJECTIVES: ISO standards for blood bags do not adequately define and control the dimensions of blood bag transfer tubing. This lack of standardization presents potential difficulties when making sterile connections between the wide range of tubing that has evolved in the absence of such standards. We aim to validate the suitability of the TSCD-II and provide a minimum standard for assessing the suitability of sterile connections (welds) between dissimilar tubing. MATERIALS AND METHODS: The Terumo TSCD-II was used in this study to connect by hermetic welding seven tubing types with a wide range of dimensions from five suppliers. Thirty sterile connections were made between each combination split between dry/dry, wet/wet and dry/wet connections. Welds were assessed for visual defects, by tensile stress test (TST) and pressure tests. RESULTS: All welds passed visual inspection and pressure tests. All welds had a minimum tensile strength of greater than 40 N and mean of greater than 45 N. CONCLUSION: Successful connections have been made between dissimilar tube types and this work does not support the requirement for 'tight' tubing dimensional specifications. We have recommended to the ISO Technical Committee 76 Work Group 1 that ISO 3826-1 be revised and should include a minimum standard validation protocol for joining dissimilar tubing.

Improved strategy for screening prospective blood donors for anaemia.

Women (568) and men (531) attending blood donation sessions in Wessex in September, 1992, were assessed for anaemia by the standard CuSO4 method on finger-prick (FP) blood samples. The haemoglobin (Hb) concentration on FP samples and on venous blood was also checked using the HemoCue. Different FP samples from the same donors revealed a wide variation on HemoCue. We recommend retaining the CuSO4 method on FP samples as the initial screen, and follow-up of apparent failures by determining the Hb concentration on venous sampling with the HemoCue. As 54% of females were found on venous samples to be below the current recommended threshold (125 g/L) for Hb concentration, we also recommend lowering the threshold to 115 g/L for women, and to 130 g/L for men. We further recommend a close re-examination of normal haematology values for adults.

Platelet counting using plasma platelet concentrate samples.

Platelet counting using samples of plasma from platelet concentrates prepared for transfusion was assessed. The methods employed included a manual phase-contrast method, and counting with Coulter S Plus and Sysmex E-2500 counters. All methods were reproducible (mean CV of 4.9, 2.2 and 1.4%, respectively). However, neat samples of platelet concentrates analysed by Coulter counter were inaccurate (mean count of 863.8 x 10(9)/l compared to 1018.9 x 10(9)/l counted manually). Moreover, the Coulter platelet counts were non-linear above 900 x 10(9)/l, whereas the E-2500 platelet counts were linear to 2700 x 10(9)/l. A one-in-three pre-dilution was required to obtain accurate, linear counts with the Coulter counter, whereas the E-2500 was accurate without pre-dilution (mean count of 1030.2 x 10(9)/l compared to 1018.9 x 10(9)/l counted manually). In conclusion, the method of platelet counting may affect true platelet yields.