title: Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?--A pilot study and a proposal.
abstract: BACKGROUND
  The implementation of national and international guidelines is beginning to standardise clinical practice. However, since many guidelines have decision limits based on laboratory tests, there is an urgent need to ensure that different laboratories obtain the same analytical result on any sample. A scientifically-based quality control process will be a pre-requisite to provide this level of analytical performance which will support evidence-based guidelines and movement of patients across boundaries while maintaining standardised outcomes. We discuss the finding of a pilot study performed to assess UK clinical laboratories readiness to work to a higher grade quality specifications such as biological variation-based quality specifications.
  
  
  METHODS
  Internal quality control (IQC) data for HbA1c, glucose, creatinine, cholesterol and high density lipoprotein (HDL)-cholesterol were collected from UK laboratories participating in the Bio-Rad Unity QC programme. The median of the coefficient of variation (CV%) of the participating laboratories was evaluated against the CV% based on biological variation.
  
  
  RESULTS
  Except creatinine, the other four analytes had a variable degree of compliance with the biological variation-based quality specifications. More than 75% of the laboratories met the biological variation-based quality specifications for glucose, cholesterol and HDL-cholesterol. Slightly over 50% of the laboratories met the analytical goal for HBA1c. Only one analyte (cholesterol) had a performance achieving the higher quality specifications consistent with 5σ.
  
  
  CONCLUSIONS
  Our data from IQC do not consistently demonstrate that the results from clinical laboratories meet evidence-based quality specifications. Therefore, we propose that a graded scale of quality specifications may be needed at this stage.
authors.affiliation: Department of Clinical Biochemistry, Harrogate District Foundation Trust, Lancaster Park Road, Harrogate, HG2 7SX, UK. nuthar@hdft.nhs.uk
authors.forename: Nuthar
authors.initials: N
authors.lastname: Jassam
authors.forename: John
authors.initials: J
authors.lastname: Yundt-Pacheco
authors.forename: Rob
authors.initials: R
authors.lastname: Jansen
authors.forename: Annette
authors.initials: A
authors.lastname: Thomas
authors.forename: Julian H
authors.initials: JH
authors.lastname: Barth
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D003920:Diabetes Mellitus / Q000175:diagnosis*; D006287:Health Planning Guidelines; D006801:Humans; D017202:Myocardial Ischemia / Q000175:diagnosis*; D010865:Pilot Projects; D011786:Quality Control; D006113:United Kingdom