Gisborne Hospital Report - Health and Disability Commissioner

Gisborne Hospital 1999 – 2000
PSA Testing Procedures
• scant documentation for the quality control system and review of the
department’s internal and external quality control was non-existent.
5.16 THL took the suspension of Biochemistry in late 1998 seriously and took the
following steps:
• employed a consultant technologist to set up a new system for quality
assurance and management of the laboratory;
• prepared an action plan which was approved by IANZ, with reporting
criteria;
• employed a Laboratory Manager, who was an IANZ accredited
assessor, to manage the process; and
• appointed a quality assurance officer with the aid of the IANZ assessor.
5.17 IANZ was satisfied with the remedial steps and reaccredited the biochemistry
section of the laboratory. However, it is clear from both the IANZ special
assessment on 17-18 July 2000 and from this investigation that many of the
deficiencies identified by IANZ in December 1998 had not been adequately
corrected by March 2000.
5.18 THL pointed out in their response to the provisional opinion that “senior
management relied on the level of surveillance by IANZ, and the skills of the
laboratory manager to ensure that laboratory services met quality standards”.
5.19 How was it, then, that IANZ lifted the suspension of registration? IANZ
provides a general, overall assessment of the procedures being used within a
laboratory. It does not attempt to provide a detailed audit of all of the
procedures. IANZ see its function as carrying out an assessment of a
laboratory that is assumed to have quality systems in place, sufficient to meet
all of the standards laid down by IANZ for accreditation. In the process of
carrying out the assessment, the assessors may detect practices that fall short
of these standards, and these will then be raised as Corrective Action Requests
(CAR). It is a very rare event for a CAR to be serious enough to result in deregistration.
5.20 It is a requirement of the Code of Laboratory Management Practice that
internal audits be carried out by each laboratory at least once every 12 months,
by a suitably qualified technologist from another section of the laboratory or
another laboratory. The IANZ Assessment Report of July 2000 found this
requirement had not been complied with.
The proposal to contract out
5.21 The THL Board received a proposal to contract out laboratory services at its
meeting in May 1999. The former Chairperson commented that this was the
third strategy the Board had been asked to endorse, following earlier strategies
of purchase of the private laboratory and competing for community referred
161