The implementation of a system for managing analytical quality in networked laboratories.


BACKGROUND:In a network of laboratories analytical variability between instruments, even of the same type, may exist for reasons beyond the control of laboratory staff. Controlling variability is a prerequisite for the application of shared reference ranges and for ensuring the transferability of patient test results. Controlling variability requires a robust, non-conventional quality system to detect poor performance of analysers that are geographically distant. Essential to this quality system is a set of well-defined quality specifications. METHODS:The approach used in our study started with (1) selection of a model for quality specifications based on biological variation; the 'three-level model' (TLM) was selected on the basis of its flexibility to accommodate various levels of analytical performance; (2) determination of the performance characteristics of the 71 analytes measured in core biochemistry in terms of imprecision and bias; (3) defining quality requirements in the form of imprecision, bias and total error for 71 analytes measured routinely in core biochemistry; and (4) developing software to assist a consistent wide application of the quality specifications and to monitor analytical indices to the common quality specifications. RESULTS:In this paper we describe how we have implemented this model across our network. Forty-six of the 71 analytes in our core laboratory repertoire were allocated to the TLM. We were able to demonstrate equivalence of results on all analysers, for 42 out of 46 analytes allocated to this model. CONCLUSIONS:We propose that other networked laboratories should investigate the suitability of this quality system for use in their network.


Ann Clin Biochem


Jassam N,Lindsay C,Harrison K,Thompson D,Bosomworth MP,Barth JH




Has Abstract


2011-03-01 00:00:00




Pt 2










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    abstract::Digoxin requesting patterns were studied prospectively over a 6-month period. Clinicians were not forewarned that the study was being undertaken. Many samples received in the laboratory were taken at incorrect times after the drug had been given. This led to inappropriate action being taken in some cases. Appropriate ...

    journal_title:Annals of clinical biochemistry

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    authors: O'Donnell JG,Paterson NC,Pledger DR,Stewart MJ

    更新日期:1987-07-01 00:00:00

  • Identification of glucagon-like peptide-1(7-36) amide in rat brain.

    abstract::Acid-urea extract of rat brain was examined by glucagon-like peptide-1 (GLP-1) specific radioimmunoassay. A single peak was observed which co-eluted with GLP-1(7-36)amide on gel filtration and anion exchange chromatography. In contrast, GLP-1(1-37) was not detected under our experimental conditions. The fact that GLP-...

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    authors: Yoshimoto S,Hirota M,Ohboshi C,Shima K

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  • Bloodspot testosterone assay suitable for study of neonates and monitoring of children with congenital adrenal hyperplasia.

    abstract::A bloodspot assay for testosterone has been developed using an antiserum raised against testosterone-3-carboxymethyloxime-bovine serum albumin (T-3 CMO-BSA) conjugate and 125I-T-3CMO-histamine tracer. The method has a detection limit of 0.4 nmol/L with between-batch precision of less than 15% for testosterone values b...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章


    authors: Walker J,Hughes IA,Wood PJ

    更新日期:1999-07-01 00:00:00

  • Troponin T for the differential diagnosis of ischaemic myocardial damage.

    abstract::The diagnostic performance of a new enzyme linked immunosorbent assay for the cardiac structural protein troponin T in the differential diagnosis of ischaemic cardiac damage was assessed. A well documented set of patients admitted to the coronary care unit of a district general hospital were studied. At a cutoff value...

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    pub_type: 杂志文章


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  • Glucose tolerance test and glycosylated haemoglobin measurement for diagnosis of diabetes mellitus--an assessment of the criteria of the WHO Expert Committee on Diabetes Mellitus 1980.

    abstract::Fasting glycosylated haemoglobin was analysed in 535 consecutive patients having an oral 75 g glucose tolerance test for diagnostic purposes. A reference range for fasting glycosylated haemoglobin was established from patients with a non-diabetic glucose tolerance test as defined by the World Health Organisation Exper...

    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章


    authors: Albutt EC,Nattrass M,Northam BE

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  • Cerebrospinal fluid biochemistry in the diagnosis of multiple sclerosis.

    abstract::The Poser criteria for diagnosing multiple sclerosis (MS) includes clinical, paraclinical and laboratory information. We studied the influence of cerebrospinal fluid (CSF) biochemistry results on the categorisation of patients with suspected MS. A retrospective study was made of 138 patients who had CSF samples sent o...

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    pub_type: 杂志文章


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    pub_type: 杂志文章


    authors: Morita K,Kawamoto H,Takada H,Nakamura S,Ishii K,Okamoto Y

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    authors: Morava E,Kosztolányi G,Engelke UF,Wevers RA

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    pub_type: 杂志文章


    authors: Nakamura K,Takeuchi T,Ohkawa R,Okubo S,Yokota H,Tozuka M,Aoki J,Arai H,Ikeda H,Ohshima N,Kitamura T,Yatomi Y

    更新日期:2007-11-01 00:00:00

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    pub_type: 杂志文章


    authors: Digby J,Strachan JA,McCann R,Steele RJ,Fraser CG,Mowat C

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    pub_type: 杂志文章


    authors: Rocks BF,Sherwood RA,Cook JG

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    pub_type: 杂志文章


    authors: Oosterhuis WP,Modderman TA,Dinkelaar RB,Zwinderman AH,van der Helm HJ

    更新日期:1991-07-01 00:00:00

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    authors: Lankes U,Elder PA,Lewis JG,George P

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    authors: Stevenson JD,Chapman RS,Perry B,Logue FC

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    pub_type: 杂志文章,评审


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  • Interference of ascorbic acid with chemical analytes.

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    authors: Wilke TJ,Turnbull PA

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    authors: Olpin SE

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    pub_type: 杂志文章


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    pub_type: 杂志文章


    authors: Ishikawa H,Matsuzawa T,Ohashi K,Nagamura Y

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  • The ratio of erythrocyte zinc-protoporphyrin to protoporphyrin IX in disease and its significance in the mechanism of lead toxicity on haem synthesis.

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    authors: Nelson JC,Westwood M,Allen KR,Newton KE,Barth JH

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    authors: Ford RP

    更新日期:1989-05-01 00:00:00

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    pub_type: 杂志文章


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    更新日期:2005-05-01 00:00:00

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    pub_type: 杂志文章


    authors: Masuda S,Ichihara K,Yamanishi H,Hirano Y,Tanaka Y,Kamisako T,Scientific Committee for Asia-Pasific Federation of Clinical Biochemistry.

    更新日期:2016-05-01 00:00:00

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    pub_type: 杂志文章


    authors: Misao R,Nakanishi Y,Fujimoto J,Tamaya T

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    journal_title:Annals of clinical biochemistry

    pub_type: 杂志文章


    authors: Barlow NL,Holme J,Stockley RA,Clark PM

    更新日期:2010-05-01 00:00:00