Gisborne Hospital Report - Health and Disability Commissioner

Gisborne Hospital 1999 – 2000
PSA Testing Procedures
7.25 In addition, there is evidence that internal QC data was either changed to make
it fit the expected values, and/or that there was an inadequate response to the
information being shown by the internal QC programme. Mr Rutledge denied
altering any data to fit expected values.
7.26 External quality assurance is a means of retrospectively comparing
performance against that of other laboratories. It is the final check that the
data being produced is valid. Failure to submit PSA results to an external QC
programme meant that the final safety net was missing and the problem was
not detected. Even if the cost of submitting results to the programme was
considered an issue, failure to participate when a programme was available
breached IANZ registration requirements.
7.27 It is essential that all of the staff fully understand the purpose of the QC
programme, the implications of tests appearing to be out of control, and what
they should do to rectify the problem. With such a small pool of staff, all of
whom are expected to perform all test procedures, they all need to be included
in regular section meetings to review test performance so that they know what
actions are being taken to rectify any quality problems.
Mr John Rutledge
7.28 Mr Rutledge made a series of errors of judgement when faced with control
samples for PSA that produced unexpected results. Internal quality control
data alerted him to the problem, but he did not understand the significance of
the data and so his response was not correct. He should have sought further
advice from the reagent/calibrator suppliers and colleagues in other
laboratories performing the same test procedure if the reasons for the abnormal
data were not clear to him.
7.29 Altering QC data to fit previous results is not acceptable and makes the
internal QC process pointless.
7.30 The rest of the technical staff, including the Quality Manager appointed after
the 1998 suspension of accreditation, were also inadequately trained to
understand the significance of this data. In their defence, Mr Rutledge had a
special interest in his PC-based QC programme (QC Reporter 2.0), and so they
probably assumed that he knew what he was doing and that there was no cause
for concern. Mr Rutledge’s managers knew he was using the PC-based QC
system. He presented a paper about his system at a laboratory technology
conference.
7.31 Mr Rutledge had instituted a PC-based internal quality assurance system that
he believed was more user-friendly than that available on the analysers,
although not all of his staff agreed with this view. Unfortunately, delays in
transcribing results meant that the information it provided was not
immediately available, and so it had limited practical use. On a modern
automated analyser, it is the minimum normal practice to run control samples
at the beginning of each day, and whenever a new batch of reagents is placed
on the analyser. It would have been better to have used the analyser-based QC
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