Gisborne Hospital Report - Health and Disability Commissioner

Gisborne Hospital 1999 – 2000
PSA Testing Procedures
invoices from Abbott Diagnostics confirm that Total PSA controls were
supplied and presumably were used.
3.43 Mr Rutledge noted that in the past, the manufacturer, Abbott Diagnostics,
would have questioned an order for PSA reagents and for Total PSA
calibrators, and asked if the order was what the laboratory wanted. In other
words, the manufacturer would have picked up the error. Mr Rutledge
surmised that this no longer occurs. THL said there is nothing to support this
assertion and that Abbott Diagnostics have indicated that they have no systems
that allow for that sort of checking.
3.44 The laboratory did not inform the clinicians as to the lower than expected
results because of the change to a new PSA kit. Part of the reason for this
related to the lack of ready access to a pathologist who could interpret and
relay the message to clinicians.
3.45 Mr Rutledge also indicated that it is likely that he would have “mentioned the
difference he was observing with the new PSA controls if he had been able to
talk to someone at a biochemistry special interest group meeting”. He was not
given the opportunity to attend these meetings. The situation did not cause
him to make further inquiries because he had rationalised the results to
himself. THL point out that Mr Rutledge had access to the internet, which he
used extensively, and that all he needed to do was read the manufacturer’s
instructions on the packet.
4. RESPONSE OF TAIRAWHITI HEALTHCARE
4.1 Once THL was aware of a problem with the PSA testing, prompt action was
taken. The action focused on two fronts: to determine how best to respond to
the affected patients, and to deal with the quality issues raised by the discovery
of the problem.
4.2 THL did not know the full nature of the problem until Friday 7 July 2000
when it received the correlation from Canterbury Health that revealed 500
tests were involved. On Sunday 9 July it was decided to alert the Minister of
Health the next day. In fact, the Minister was alerted on Tuesday, 11 July
2000.
4.3 A multi-disciplinary team was put together to manage the PSA incident. It
comprised Ms Lynsey Bartlett (Quality Co-ordinator), Dr Bruce Duncan
(Clinical Director (Public Health)), Mr Brian Cowper (Project Manager), Mrs
Pat Seymour (the Chairperson of the Board), Ms Sheryl Smail (the CEO) and
Mr Mike Grant (Group Manager (Community and Support Services)). The
following timetable sets out the steps that were taken by THL to manage the
PSA incident, from 26 June 2000 to 17 July 2000.
Incident Process
26/06/2000 Ms Beverley Peterson, BSc, BA, ANZIMLS employed as a
locum technologist specifically to review QC procedures in
biochemistry.
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