title: Nuclear medicine incident reporting in Australia: control charts and notification rates inform quality improvement.
abstract: 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.
  
  
  OBJECTIVE
  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; χ(2) = 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.
authors.affiliation: Department of Nuclear Medicine and Ultrasound, Westmead Hospital, Sydney, Australia.|Department of Sydney Medical School, University of Sydney, Sydney, Australia.
authors.forename: G
authors.initials: G
authors.lastname: Larcos
authors.affiliation: Department of Medical Physics, Westmead Hospital, Sydney, Australia.
authors.forename: L T
authors.initials: LT
authors.lastname: Collins
authors.affiliation: Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Georgiou
authors.affiliation: Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
authors.forename: J I
authors.initials: JI
authors.lastname: Westbrook
mesh_terms: D001315:Australia / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D019300:Medical Errors / Q000331:legislation & jurisprudence / Q000517:prevention & control; D009683:Nuclear Medicine / Q000331:legislation & jurisprudence / Q000592:standards*; D058996:Quality Improvement / Q000331:legislation & jurisprudence / Q000592:standards*; D019275:Radiopharmaceuticals / Q000009:adverse effects*; D012042:Registries; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000592:standards*
chemical_list: D019275:Radiopharmaceuticals
keywords: healthcare; hospital incident reporting; nuclear medicine; quality assurance; radiation protection; risk management