title: Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE).
abstract: BACKGROUND
  An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines.
  
  
  METHODS
  A structured checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors occurring during phlebotomy was graded using the risk occurrence chart.
  
  
  RESULTS
  Twelve European countries participated with a median of 33 (18-36) audits per country, and a total of 336 audits. The median error rate for the total phlebotomy procedure was 26.9 % (10.6-43.8), indicating a low overall compliance with the recommended CLSI guideline. Patient identification and test tube labelling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy, whereas physicians did not adhere to test tube labelling policy.
  
  
  CONCLUSIONS
  The level of compliance of phlebotomy procedures with the CLSI H3-A6 guidelines in 12 European countries was found to be unacceptably low. The most critical steps in need of immediate attention in the investigated countries are patient identification and tube labelling.
authors.forename: Ana-Maria
authors.initials: AM
authors.lastname: Simundic
authors.forename: Stephen
authors.initials: S
authors.lastname: Church
authors.forename: Michael P
authors.initials: MP
authors.lastname: Cornes
authors.forename: Kjell
authors.initials: K
authors.lastname: Grankvist
authors.forename: Giuseppe
authors.identifier: http://orcid.org/0000-0001-9523-9054
authors.initials: G
authors.lastname: Lippi
authors.forename: Mads
authors.initials: M
authors.lastname: Nybo
authors.forename: Nora
authors.initials: N
authors.lastname: Nikolac
authors.forename: Edmee
authors.initials: E
authors.lastname: van Dongen-Lases
authors.forename: Pinar
authors.initials: P
authors.lastname: Eker
authors.forename: Svjetlana
authors.initials: S
authors.lastname: Kovalevskaya
authors.forename: Gunn B B
authors.initials: GB
authors.lastname: Kristensen
authors.forename: Ludek
authors.initials: L
authors.lastname: Sprongl
authors.forename: Zorica
authors.initials: Z
authors.lastname: Sumarac
mesh_terms: D001800:Blood Specimen Collection / Q000592:standards*; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D018962:Phlebotomy; D017410:Practice Guidelines as Topic; D018570:Risk Assessment; D012958:Societies, Scientific / Q000592:standards*; D011795:Surveys and Questionnaires