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Problem Statement

International Accreditation New Zealand (IANZ) accreditation to ISO 15189:2012 provides formal recognition that the laboratory has been independently assessed in five key areas:

  • competence and experience of staff
  • integrity and traceability of equipment and materials
  • technical validity of methods
  • validity and suitability of results
  • compliance with appropriate management systems standards and competency to carry out services in a professional, reliable and efficient manner.

What are we trying to achieve?

CM Health Laboratory Services is a registered medical testing laboratory.

To maintain accreditation, the laboratory service is required to undergo an annual assessment. Assessments are in 4 year cycles of three surveillance assessments and one reassessment.

Reassessments include quality systems, clinical and technical/scientific scrutiny. Surveillance assessments are carried out by IANZ staff and focus on quality systems.

The April 2019 assessment was a routine surveillance assessment.

What have we done?

The routine surveillance assessment for CM Health Laboratory Services was carried out by IANZ from 9 to 12 April 2019.

This assessment has confirmed that the laboratory continued to generally comply with the requirements for accreditation. However, a number of significant concerns were identified pertaining to record keeping of some personnel records, equipment maintenance and internal audits. Responses to these three major non-conformances are required by 9 August 2019.

A recommendation to continued accreditation upon clearance of these non-conformances may be made without reservation.

Note that the histology and cytology (non-gynaecological) disciplines were not assessed as part of this assessment as a new histology laboratory facility is being refurbished in the ground floor Galbraith Building. Relocation is scheduled to occur on 12 August. A separate reassessment will be arranged once the relocation is complete.

What did we find?

Major non-conformance 1: Transfusion Medicine (Middlemore Hospital) and Manukau SuperClinic

It is an expectation of accreditation that records are maintained for each item of equipment that contributes to the performance of examination. A significant number of incomplete records were identified.

Major non-conformance 2: Competence assessment and review of staff performance         

It is an expectation of accreditation that competency assessment and staff performance reviews are conducted in a timely manner with appropriate records readily available for review. Additionally, these records must include all components of assigned managerial or technical tasks relevant to each staff member.

Major non-conformance 3: Evaluation and audits – general

It is an expectation of accreditation that a minimum of 10 percent of data registrations are audited on a regular basis. Whilst vertical audits were conducted, anomalies were noted.

How did we make a difference?

The Laboratory Service is currently working through each of the issues raised. Improvements to existing quality systems have already been implemented to ensure full compliance is maintained. These responses, with evidence, will be provided to IANZ before the specified clearance dates.

Where to from here?

Turn-around times are used as key performance indicators. CM Health Laboratory Services consistently performs well and in the top half compared with other participating district health board laboratories for a number of key assays.

CM Health Laboratory Service actively seeks feedback from users and is constantly looking for quality improvements.

An upgrade to IT software (the core laboratory information system) is being implemented later in 2019. This will enable electronic orders to be implemented at a later stage.

The histology laboratory service is looking forward to working from a refurbished facility, which will remove the space constraints they currently work under.

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