Nuclear medicine incident reporting in Australia : control charts and notification rates inform quality improvement

Background: Australia has a statutory incident reporting system for radiopharmaceutical maladministrations, but additional research into registry data is required for the purpose of quality improvement in nuclear medicine. Aims: We (i) used control charts to identify factors contributing to special cause variation (indicating higher than expected rates) in maladministrations and (ii) evaluated the impact of heterogeneous notification criteria and extent of underreporting among jurisdictions and individual facilities, respectively. Methods: Anonymised summaries of Australian Radiation Incident Register reports permitted calculation of national monthly maladministration notification rates for 2007–2012 and preparation of control charts. Multivariate logistic regression assessed the association of population, insurance and regulatory characteristics with maladministration notifications in each Australian State and Territory. Maladministration notification rates from two facilities with familiarity of notification processes and commitment to radiation protection were compared with those elsewhere. Results: Special cause variation occurred in only 3 months, but contributed to 21% of all incidents (42 of 197 patients), mainly because of 'clusters' of maladministrations (n = 24) arising from errors in bulk radiopharmaceutical dispensing. Maladministration notification rates varied significantly between jurisdictions (0 to 12.2 maladministrations per 100 000 procedures (P < 0.05)) and individual facilities (31.7 vs 5.8 per 100 000; χ² = 40; 1 degree of freedom, P < 0.001). Conclusions: Unexpected increases in maladministration notifications predominantly relate to incident 'clusters' affecting multiple patients. The bulk preparation of radiopharmaceuticals is a vulnerable process and merits additional safeguards. Maladministration notification rates in Australia are heterogeneous. Adopting uniform maladministration notification criteria among States and Territories and methods to overcome underreporting are warranted.9 page(s

Improved tolerance to missing data in myocardial perfusion SPET using OSEM reconstruction

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Imaging of deep venous thrombosis in patients using a radiolabelled anti-D-dimer Fab′ fragment (99mTc-DI-DD3B6/22-80B3): results of a phase I trial

Purpose 99mTc-DI-DD3B6/22-80B3 (ThromboView®, hereafter abbreviated to 99mTc-DI-80B3 Fab′) is a radiolabelled humanised monoclonal Fab′ fragment with affinity and specificity for D-dimer domains of cross-linked fibrin. Detection of thromboembolic events has been demonstrated in canine models. The study objectives were evaluation of safety and characterisation of biodistribution, immunogenicity and pharmacokinetic profile of increasing doses of 99mTc-DI-80B3 Fab′ in subjects with acute lower-limb DVT. Methods Twenty-six patients with acute lower limb DVT were enrolled. Of these, 21 received a single intravenous dose of 0.5 mg (n = 6), 1.0 mg (n = 9) or 2 mg (n = 6) 99mTc-DI-80B3 Fab′. Blood and urine samples and gamma camera images were collected to 24 h after administration for pharmacokinetic and dosimetry analysis. Vital signs, electrocardiography, hematological and biochemical data and human anti-human antibody (HAHA) levels were monitored for up to 30 days following administration. Patients were assigned to either planar or single photon emission computed tomographic (SPECT) imaging of the thorax at 4 h following injection. Results Thirty-five adverse events were reported in 15 of the 21 subjects. Those deemed possibly related to administration of 99mTc-DI-80B3 Fab′ included mild hypertension, mild elevation of LD (lactate dehydrogenase) and moderate elevation of ALT (alanine transaminase). HAHA assays remained negative. Pharmacokinetics and organ dosimetry were comparable to prior normal volunteer data. Localisation of Thromboview® to sites of known thrombus was evident as early as 30 min post-injection. Conclusions In subjects with acute DVT, 99mTc-DI-80B3 Fab′ was well tolerated with favourable characteristics for the detection of acute venous thrombosis