Journal of the American College of Radiology
Volume 7, Issue 8 , Pages 582-592 , August 2010

Establishing National Medical Imaging Incident Reporting Systems: Issues and Challenges

  • D. Neil Jones, BMBS

      Affiliations

    • Division of Medical Imaging, Flinders Medical Centre, Bedford Park, Australia
    • Human Factors Group, University of South Australia, Adelaide, Australia
    • Corresponding Author InformationCorresponding author and reprints: D. Neil Jones, BMBS, Flinders Medical Centre, Division of Medical Imaging, Level 2, Bedford Park, South Australia, 5042, Australia
  • ,
  • Klee A. Benveniste, PhD, MAPS

      Affiliations

    • Australian Patient Safety Foundation, Adelaide, Australia
  • ,
  • Timothy J. Schultz, BSc(Hons), GradDiplPubHlth, PhD

      Affiliations

    • Australian Patient Safety Foundation, Adelaide, Australia
    • Discipline of Nursing, University of Adelaide, Adelaide, Australia
  • ,
  • Catherine J. Mandel, MBBS

      Affiliations

    • Radiology Department, Peter MacCallum Cancer Centre, East Melbourne, Australia
  • ,
  • William B. Runciman, MBBCh, PhD

      Affiliations

    • Human Factors Group, University of South Australia, Adelaide, Australia
    • Australian Patient Safety Foundation, Adelaide, Australia

References 

  1. Donaldson L. When will health care pass the orange-wire test?. Lancet. 2004;364:1567–1568
  2. Runciman W, Hibbert P, Thomson R, Van Der Schaaf T, Sherman H, Lewalle P. Towards an international classification for patient safety: key concepts and terms. Int J Qual Health Care. 2009;21:18–26
  3. Jha A. Summary of the evidence on patient safety: implications for research. Geneva, Switzerland: World Health Organization; 2008;
  4. Runciman B, Merry A, Walton M. Safety and ethics in healthcare: a guide to getting it right. Aldershot, UK: Ashgate; 2007;
  5. World Alliance for Patient SafetyWorld Health Organization. Global priorities for research in patient safety. Geneva, Switzerland: World Health Organization; 2008;
  6. Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health system. Washington, DC: National Academy Press; 2000;
  7. Department of Health. An organisation with a memory—report of an expert group on learning from adverse events in the NHS chaired by the chief medical officer. London: Her Majesty's Stationery Office; 2000;
  8. Runciman WB, Moller J. Iatrogenic injury in Australia. Adelaide: Australian Patient Safety Foundation; 2001;
  9. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients (Results of the Harvard Medical Practice Study I). N Engl J Med. 1991;324:370–376
  10. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients (Results of the Harvard Medical Practice Study II). N Engl J Med. 1991;324:377–384
  11. Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care. 2000;38:261–271
  12. Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD. The Quality in Australian Health Care Study. Med J Aust. 1995;163:458–471
  13. Thomas EJ, Studdert DM, Runciman WB, et al. A comparison of iatrogenic injury studies in Australia and the USA (I: context, methods, casemix, population, patient and hospital characteristics). Int J Qual Health Care. 2000;12:371–378
  14. Runciman WB, Webb RK, Helps SC, et al. A comparison of iatrogenic injury studies in Australia and the USA (II: reviewer behaviour and quality of care). Int J Qual Health Care. 2000;12:379–388
  15. Vincent C, Neale G, Woloshynowych M. Adverse events in British hospitals: preliminary retrospective record review. BMJ. 2001;322:517–519
  16. Davis P, Lay-Yee R, Briant R. Adverse events in New Zealand public hospitals: principal findings from a national survey (Occasional paper no 3). Wellington, New Zealand: Ministry of Health; 2001;
  17. Schioler T, Lipczak H, Pedersen BL, et al. Incidence of adverse events in hospitals (A retrospective study of medical records [article in Danish]). Ugeskr Laeger. 2001;163:5370–5378
  18. Baker GR, Norton PG, Flintoft V, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ. 2004;170:1678–1686
  19. Michel P, Quenon J, Djihoud A, Tricaud-Vialle S, de Sarasqueta A, Domecq S. Les événements indésirables graves liés aux soins observés dans les établissements de santé: premiers résultats d'une étude nationale (Études et Résultats No 398). Paris: Direction de la Recherche des Études de L'Évaluation et des Statistiques, Ministère des Solidarités, de la Santé et de la Famille; 2005;
  20. Andrés JMA, Remón CA, Burillo JV, Lopez PR. National Study on Hospitalisation-Related Adverse Events ENEAS 2005. Madrid, Spain: Ministry of Health and Consumer Affairs; 2006;
  21. Soop M, Fryksmark U, Köster M, Haglund B. The incidence of adverse events in Swedish hospitals: a retrospective medical record review study. Int J Qual Health Care. 2009;21:1–7
  22. Zegers M, de Bruijne MC, Wagner C, et al. Adverse events and potentially preventable deaths in Dutch hospitals: results of a retrospective patient record review study. Qual Saf Health Care. 2009;18:297–302
  23. Hayward RA, Hofer TP. Estimating hospital deaths due to medical errors: preventability is in the eye of the reviewer. JAMA. 2001;286:415–420
  24. Andrews LB, Stocking C, Krizek T, et al. An alternative strategy for studying adverse events in medical care. Lancet. 1997;349:309–313
  25. Hogan H, Olsen S, Scobie S, et al. What can we learn about patient safety from information sources within an acute hospital: a step on the ladder of integrated risk management?. Qual Saf Health Care. 2008;17:209–215
  26. Cooper JB, Newbower RS, Long CD, McPeek B. Preventable anesthesia mishaps: a study of human factors. Anesthesiology. 1978;49:399–406
  27. Williamson J. Critical incident reporting in anaesthesia. Anaesth Intensive Care. 1988;16:101–103
  28. Williamson JA, Mackay P. Incident reporting. Med J Aust. 1991;155:340–344
  29. Runciman WB, Sellen A, Webb RK, et al. The Australian Incident Monitoring Study (Errors, incidents and accidents in anaesthetic practice). Anaesth Intensive Care. 1993;21:506–519
  30. Battles JB, Stevens DP. Adverse event reporting systems and safer healthcare. Qual Saf Health Care. 2009;18:2
  31. Meyer GS, Battles J, Hart JC, Tang N. The US Agency for Healthcare Research and Quality's activities in patient safety research. Int J Qual Health Care. 2003;15(suppl):i25–i30
  32. World Alliance for Patient Safety. WHO draft guidelines for adverse event reporting and learning systems. Geneva, Switzerland: World Health Organization; 2005;
  33. Cook RI, Woods DD, Miller C. A tale of two stories: contrasting views of patient safety (Report from a Workshop on Assembling the Scientific Basis of Patient Safety). Chicago, Ill: National Patient Safety Foundation at the AMA; 1998;
  34. Benn J, Koutantji M, Wallace L, et al. Feedback from incident reporting: information and action to improve patient safety. Qual Saf Health Care. 2009;18:11–21
  35. Bagian JP. Patient safety: lessons learned. Pediatr Radiol. 2006;36:287–290
  36. Runciman WB, Williamson JA, Deakin A, Benveniste KA, Bannon K, Hibbert PD. An integrated framework for safety, quality and risk management: an information and incident management system based on a universal patient safety classification. Qual Saf Health Care. 2006;15(suppl):i82–i90
  37. Jones D, Runciman WB. Principles of incident reporting. In:  Croskerry P,  Cosby KS,  Schenkel SM,  Wears RL editor. Patient safety in emergency medicine. Philadelphia: Lippincott Williams & Wilkins; 2008;p. 70–74
  38. Kingston MJ, Evans SM, Smith BJ, Berry JG. Attitudes of doctors and nurses towards incident reporting: a qualitative analysis. Med J Aust. 2004;181:36–39
  39. Braithwaite J, Westbrook M, Travaglia J. Attitudes toward the large-scale implementation of an incident reporting system. Int J Qual Health Care. 2008;20:184–191
  40. US Food and Drug Administration. Manufacturer and User Facility Device Experience Database (MAUDE). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htmAccessed December 18, 2009
  41. Australian Government Department of Health and AgeingTherapeutic Goods Administration. http://www.tga.gov.auAccessed December 18, 2009
  42. Department of HealthMedicines and Healthcare Products Advisory Agency. http://www.mhra.gov.uk/index.htmAccessed December 18, 2009
  43. White JL. Adverse event reporting and learning systems: a review of the literature. Edmonton: Canadian Patient Safety Institute; 2007;
  44. Aspden P, Corrigan JM, Wolcott J, Erickson SM. Institute of Medicine Committee on Data Standards. In: Patient safety: achieving a new standard for care. Washington, DC: National Academies Press; 2004;
  45. Levtzion-Korach O, Alcalai H, Orav EJ, et al. Evaluation of the contributions of an electronic web-based reporting system: enabling action. J Patient Saf. 2009;5:9–15
  46. Farley DO, Haviland A, Champagne S, et al. Adverse-event-reporting practices by US hospitals: results of a national survey. Qual Saf Health Care. 2008;17:416–423
  47. Shojania KG. The frustrating case of incident-reporting systems. Qual Saf Health Care. 2008;17:400–402
  48. Evans SM, Berry JG, Smith BJ, et al. Attitudes and barriers to incident reporting: a collaborative hospital study. Qual Saf Health Care. 2006;15:39–43
  49. Mankad K, Hoey ET, Jones JB, Tirukonda P, Smith JT. Radiology errors: are we learning from our mistakes?. Clin Radiol. 2009;64:988–993
  50. Waring JJ. Beyond blame: cultural barriers to medical incident reporting. Soc Sci Med. 2005;60:1927–1935
  51. Smith AF, Mahajan RP. National critical incident reporting: improving patient safety. Br J Anaesth. 2009;103:623–625
  52. Runciman WB, Merry AF, Tito F. Error, blame, and the law in health care—an antipodean perspective. Ann Intern Med. 2003;138:974–979
  53. Bismark M, Paterson R. No-fault compensation in New Zealand: harmonizing injury compensation, provider accountability, and patient safety. Health Aff (Millwood). 2006;25:278–283
  54. Hellbacher U, Espersson C, Johansson H. Patient injury compensation for healthcare-related injuries. http://www.patientforsakring.se/pdf/patientskadeersattning_english.pdfAccessed December 15, 2009
  55. Gilmour JM. Patient safety, medical safety and tort law: an international comparisonFinal report. http://osgoode.yorku.ca/osgmedia.nsf/0/094676DE3FAD06A5852572330059253C/$FILE/FinalReport_Full.pdfAccessed December 15, 2009
  56. Scottish GovernmentNo-fault compensation review group. http://www.scotland.gov.uk/Topics/Health/NHS-Scotland/No-faultCompensationAccessed December 15, 2009
  57. Department of Health and Children, Ireland. Advisory group on no fault compensation for brain-damaged infants. http://www.dohc.ie/working_groups/Current/cbdi/Accessed December 15, 2009
  58. Halpin SF. Medico-legal claims against English radiologists: 1995-2006. Br J Radiol. 2009;82:982–988
  59. Australian and New Zealand College of Radiologists. Welcome to the Radiology Events Register (RaER). http://www.raer.orgAccessed February 15, 2010
  60. Australian Council for Safety and Quality in Health Care. National report on qualified privilege. http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/F22384CCE74A9F01CA257483000D845E/$File/qual_priv1.pdfAccessed December 15, 2009
  61. Commonwealth of Australia. Health Insurance Act 1973. Part VC: quality assurance confidentiality. http://www.austlii.edu.au/au/legis/cth/consol_act/hia1973164/Accessed December 10, 2009
  62. Commonwealth of Australia. Health Insurance Act 1973. Declaration of quality assurance activity under section 124X. Schedule: QAA No 1/2008: RCPA Quality Assurance Programs Pty Limited. Key Incident Monitoring and Management System. Federal Register of Legislative Instruments F2009C00201; 2009. http://www.scaleplus.law.gov.au/ComLaw/legislation/legislativeinstrumentcompilation1.nsf/0/8B99C0A5F9AC53C5CA2575B70021E8A2/$file/0272009COMP3.pdfAccessed December 10, 2009
  63. Patient Safety and Quality Improvement Act of 2005. Pub L No 109-41, 2005. http://www.pso.ahrq.gov/statute/pl109-41.pdfAccessed December 10, 2009
  64. Agency for Healthcare Research and QualityPatient Safety Organization Privacy Protection Center. https://www.psoppc.org/web/patientsafetyAccessed December 10, 2009
  65. Smith S. How the dye was cast: shedding light on a dark industry. http://www.arachnoiditis.info/content/pantopaque/sarahs_pantopaque.docAccessed December 15, 2009
  66. George J. Adhesive arachnoiditis. http://parlinfo.aph.gov.au/parlInfo/genpdf/chamber/hansardr/2002-09-16/0101/hansard_frag.pdf;fileType%3Dapplication%2FpdfAccessed December 15, 2009
  67. Thomsen HS. Nephrogenic systemic fibrosis: history and epidemiology. Radiol Clin North Am. 2009;47:827–831
  68. US Food and Drug Administration. MedWatch: the FDA Safety Information and Adverse Event Reporting Program. http://www.fda.gov/safety/MedWatch/default.htmAccessed December 15, 2009
  69. GE Healthcare. Omniscan safety review advisory meeting briefing document Version 1.0. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM192009.pdfAccessed December 15, 2009
  70. Fazel R, Krumholz HM, Wang Y, et al. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009;361:849–857
  71. US Food and Drug Administration. Safety investigation of CT brain perfusion scans: update 12/8/2009. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htmAccessed December 15, 2009
  72. Radiation exposure lawsuit filed over CT scans at LA hospital. http://wwwaboutlawsuits.com/radiation-exposure-lawsuit-filed-over-ct-scans-at-la-hospital-6558/Accessed December 15, 2009
  73. US Food and Drug Administration. MAUDE adverse event report: picture archiving communication system. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=727286Accessed December 18, 2009
  74. Collins T. 290 patient safety incidents reported under NPfIT scheme. http://www.computerweekly.com/blogs/tony_collins/2008/04/290-patient-safety-incidents-r.htmlAccessed December 15, 2009
  75. Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc. 2006;13:547–556
  76. Abella HA. Canadian province probes new radiology reading messDiagn Imaging. http://www.diagnosticimaging.com/display/article/113619/1482963?verify=0Accessed December 15, 2009
  77. Health Service Executive North East Radiology Look-Back Review Steering Group. Review of chest x-rays and CT scans reported by a locum consultant radiologist at Louth Meath Hospitals from August 2006 to August 2007. http://www.hse.ie/eng/services/Publications/services/Hospitals/NERadiologyReview.pdf
  78. Garvey CJ, Connolly S. Radiology reporting—where does the radiologist's duty end?. Lancet. 2006;367:443–445
  79. Berlin L. Communicating findings of radiologic examinations: whither goest the radiologist's duty?. AJR Am J Roentgenol. 2002;178:809–815
  80. Patient safety, supported by the NPSA and the Healthcare Commission. http://wwwhsj.co.uk/patient-safety-supported-by-the-npsa-and-the-healthcare-commission/1901093.articleAccessed December 15, 2009
  81. Taylor JL. Medical negligence. Bull Hong Kong Med Assoc. 1975;27:109–113
  82. National Patient Safety Agency. Safer practice notice: early identification of failure to act on radiological imaging reports. NPSA/2007/16. http://www.nrls.npsa.nhs.uk/resources/?EntryId45=59817Accessed December 15, 2009

 This project was funded by the Quality Use of Diagnostic Imaging Program through the Royal Australian and New Zealand College of Radiologists (Sydney, Australia) and the Australian Government Department of Health and Ageing (Canberra, Australia).

PII: S1546-1440(10)00155-9

doi: 10.1016/j.jacr.2010.03.014

Journal of the American College of Radiology
Volume 7, Issue 8 , Pages 582-592 , August 2010