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Gisborne Hospital Report - Health and Disability Commissioner

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<strong>Gisborne</strong> <strong>Hospital</strong> 1999 – 2000<br />

PSA Testing Procedures<br />

benefit in producing the data. Mr Rutledge noted that the process for quality<br />

control in microbiology is different from that required in biochemistry. THL<br />

also thought that the transfer of data into the QC <strong>Report</strong>er programme was of<br />

no benefit.<br />

3.26 THL denied that the biochemistry section was short staffed over this period,<br />

contrary to what Mr Rutledge said. THL said:<br />

“Currently [the section is] being run with the same staffing as was<br />

employed immediately prior to John Rutledge’s departure <strong>and</strong> all quality<br />

controls are in place <strong>and</strong> functioning with excellent results.”<br />

3.27 Commenting on this section in the provisional opinion, THL said:<br />

“The AXSYM <strong>and</strong> Beckman analysers do have on board quality control<br />

data management systems. We believe that all hospital laboratories use<br />

the ‘on board’ systems. This is less labour intensive <strong>and</strong> more accurate<br />

through eliminating transposition errors. The AXSYM analyser did not<br />

have the quality control options set up <strong>and</strong> therefore could not reject<br />

erroneous results. This is a parameter that should be set by the operator<br />

…. [<strong>Gisborne</strong> <strong>Hospital</strong> Laboratory] was the only laboratory we are<br />

aware of that failed to set up the analyser to review patient results. The<br />

associated printer was found to be disconnected <strong>and</strong> configured<br />

inappropriately for use on the analyser. Subsequent quality control<br />

results pinpoint exactly when there was a problem. Everything was not<br />

within limits.”<br />

External system<br />

3.28 The external AQAP programme was run by the Royal College of Pathologists<br />

of Australasia for general chemistry using the Beckman analyser. On the<br />

AxSYM, the programme was run for therapeutic drugs – phenytoin <strong>and</strong><br />

digoxin - as well as for Human Chorionic Gonadotropin (pregnancy test or<br />

HCG). No AQAP external control samples were run by THL on PSA test<br />

results because THL allegedly considered this part of the external control<br />

programme to be too expensive.<br />

3.29 THL denied this was the case. It stated: “PSA testing was part of the send<br />

away testing programme, <strong>and</strong> samples were forwarded to Canterbury <strong>Health</strong><br />

<strong>and</strong> Medlab South for analysis until John Rutledge on his own behalf<br />

recommended the testing in house.”<br />

QC <strong>Report</strong>er 2.0 software programme<br />

3.30 Mr Rutledge noted that to keep up with current st<strong>and</strong>ards of care he had<br />

introduced to the laboratory a software programme - QC <strong>Report</strong>er 2.0 - to<br />

manage the data obtained from using controls. It was a quality control system<br />

independent of the ‘on board’ analyser QC programmes, <strong>and</strong> was used for<br />

statistical purposes <strong>and</strong> to pick up trends or variations over a longer term than<br />

that produced each day by the ‘on board’ analysers.<br />

146

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