title: Clinical audits and regulatory inspections--double efforts and expenses for radiation protection?
abstract: BACKGROUND
  Clinical audit as a systematic examination of medical procedures improves the quality and outcome of patient care. The purpose of a regulatory inspection is to check and verify that the operation and facilities are in full conformance with all legal requirements.
  
  
  OBJECTIVE
  To examine the content of the clinical audits and regulatory inspections of radiological procedures and whether these overlap, and to evaluate the costs to radiological units.
  
  
  METHODS
  Clinical audits were carried out at each imaging unit of Helsinki University Hospital (HUS) Medical Imaging Center in Finland in 2004 and 2005. The regulatory inspections were carried out after the clinical audits from 2005 to late 2007. The contents of the clinical audit and inspection reports were analyzed statistically and by content analysis. The results of the audits and the inspections were compared to analyze the overlaps, differences, and costs.
  
  
  RESULTS
  The validity and conditions of the safety license, lines of authority, and responsibilities for the use of radiation and patient doses caused by different examinations were evaluated in both audits and inspections. The coverage and frequency of quality control procedures were monitored in every audit and inspection, but inspectors, in addition, checked radiation output. The costs of clinical audit and inspection were under 20 cents per radiological procedure. The auditors gave 98 recommendations, while inspectors gave 62 recommendations and 25 requirements. In clinical audits most of the recommendations concerned guidelines for examining a patient. In the inspections most recommendations were in the category of quality assurance activities.
  
  
  CONCLUSIONS
  The clinical audits and regulatory inspections were cheap and had few overlapping topics, but several differences were apparent: in clinical audits, a broader and deeper view of the clinical procedures was taken by comparison with good practices, while regulatory inspections have mainly verified conformance to basic regulatory requirements.
authors.affiliation: Medical Imaging Center, Helsinki University Hospital, Helsinki, Finland. mirja.hirvonen-kari@hus.fi
authors.forename: Mirja
authors.initials: M
authors.lastname: Hirvonen-Kari
authors.forename: Hannu
authors.initials: H
authors.lastname: Järvinen
authors.forename: Leena
authors.initials: L
authors.lastname: Kivisaari
mesh_terms: D054869:Clinical Audit / Q000191:economics / Q000706:statistics & numerical data*; D019983:Guideline Adherence / Q000191:economics; D006287:Health Planning Guidelines; D017064:Process Assessment, Health Care; D011835:Radiation Protection / Q000191:economics* / Q000331:legislation & jurisprudence; D011872:Radiology Department, Hospital / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards