Gisborne Hospital Report - Health and Disability Commissioner

Gisborne Hospital 1999 – 2000
PSA Testing Procedures
mortuary, in the absence of a cytotechnologist and anatomical
pathologist.
The technician in charge of the Clinical Biochemistry left the laboratory
in March 2000.
The laboratory manager had attempted to address some of the issues in
relation to staffing with limited success.
[Hospital] management had proposed and explored alternative
structures, associations, alliances, tendering of services and management
contracts. The preferred option was still under consideration, and as
such, outstanding issues have not been addressed. [At the time of
writing this report the laboratory is still managed by Tairawhiti
Healthcare.]
The laboratory and [Hospital] management need to identify and
comprehensively address all matters of concern in relation to
management and operation of testing services, including those corrective
action issues identified in this report.
The primary issues raised in this report relate to performance with
internal and external quality control activity. There was no evidence that
biased and out-of-limit values in either internal or external quality
control activities were recognised, or that corrective action was taken.
These matters are similar to the issues that resulted in the previous
suspension of Clinical Biochemistry [in 1998].
The large bias in some analytes may affect clinical interpretation.
The assessment team informed the laboratory that it had made a
recommendation to the Chief Executive Officer of International
Accreditation New Zealand that the accreditation of Clinical
Biochemistry should be suspended. Following a review on Wednesday
19 July 2000, the suspension of Clinical Biochemistry will be confirmed.
The laboratory will need to confirm that at least all identified items and
areas of concern have been satisfactorily addressed before reinstatement
may be considered. International Accreditation New Zealand in
conjunction with an assessment team, will need to complete a follow-up
assessment to confirm implementation of effective corrective action
measures.”
The nine other corrective action requests focused on management of
laboratory staff, training of laboratory staff, laboratory quality control
procedures, procurement of consumables, review of new work, corrective
action procedures, control of non-conforming work, technical records, quality
records, equipment, test methods and procedures, and internal audits.
The Project Plan “Quality 2000”
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