It was intended to be the biggest and best of medical laboratories. Health reporter MONIQUE DEVEREUX catalogues the faults that inspectors say LabPlus must fix first.
LabPlus combines 13 laboratories that used to be scattered around central Auckland's public hospitals.
Its specialist staff perform the widest spectrum of tests of any New
Zealand laboratory, covering everything from HIV-Aids and cancer to genetics.
The three-level facility cost $20 million to build and also houses the new Auckland Mortuary. Prime Minister Helen Clark opened it on December 1.
LabPlus is the first major project completed under Auckland Healthcare's $423 million Health Services Delivery Plan and will eventually be linked to the new acute services hospital to be finished in 2003.
The major advantage of LabPlus is that all testing for central Auckland's public hospitals can be done under the same roof.
The aim is to deliver results faster, allowing earlier diagnosis and treatment.
It is also a national reference centre and will carry out a large amount of specialist testing that cannot be done at laboratories in other parts of New Zealand.
rdWhat is LabPlus required to do? All testing must comply with the New Zealand Code of Laboratory Management Practice and health and safety standards. The lab must also be accredited with International Accreditation New Zealand.
rdWhy did two LabPlus units fail to gain accreditation? LabPlus is made up of nine units, but two of those - virology/immunology (viruses and the immune system) and chemical pathology (measuring chemicals in body fluids) - did not meet the required operating standards.
The problems included taking too long to return urgent tests, and absence of staff records of competency and other documentation.
IANZ was also unhappy with the shortage of staff, especially the vacancies in several key positions.
rdWhy is there such a shortage of staff? LabPlus employs 21 fulltime-equivalent pathologists. Three of the nine pathologists working in one section of LabPlus resigned, and the hospital has been able to hire only one replacement.
At the time of the IANZ review, LabPlus was working without clinical or technical heads of histology (study of tissues), or a clinical head of chemical pathology.
The team leader of the molecular genetics section had also recently resigned, and there was at least one vacancy in the haematology (blood) unit.
The pathologists said the resignations had been sparked by a poor attitude from management and low pay compared with what other countries offered, yet Auckland Healthcare said the pathologists left for lifestyle reasons.
rdWhat must LabPlus do before its two suspended areas can start testing again? Before IANZ will lift the suspension, several problems must be addressed.
One of the most significant was in both the virology/immunology and chemical pathology departments where the turnaround time for tests, including those marked urgent, was up to 10 times longer than it should have been. LabPlus must ensure there are enough staff to meet the workload.
In chemical pathology, LabPlus must develop a schedule for the review and revision of its procedures documentation - some of which IANZ found had not been reviewed since 1996 to 1998.
Management systems were also criticised, and LabPlus has been told to initiate a formal management review process in its histology section immediately.
In other areas, IANZ also requires LabPlus to make sure its documentation is up to date, make someone responsible for monitoring staff competence and locate or redevelop training and competency documents.
It must also initiate a formal management review process, provide details of a recruiting drive to counter a chronic staff shortage, and upgrade air-extraction mechanisms in parts of the building.
rdWhat specific areas did IANZ consider lacked detailed documentation? In the haematology department, IANZ found that some of the amendment logs used to record reviews and changes in instruction manuals had not been used since 1997.
It found that some manuals had inserts that were undated or not confirmed as current, and some included indexes listing their contents as numbered sections - except that the actual sections in the manual were not numbered.
In the virology/immunolgy section, some policy and procedure manuals showed no evidence of review since 1996, and in chemical pathology some did not appear to have been reviewed since between 1996 and 1998.
rdWere the policy and procedure manuals the only documentation not up to scratch? No. IANZ requires LabPlus to make sure all of its documentation is up to date and to locate or redevelop training and competency documents.
In the histology and cytology sections, staff could not find the training and competence records and suggested the review process was inoperative.
rdIf there is no documented record of staff competence, is the public at an above-average risk of having tests misdiagnosed?
No. Although IANZ has asked LabPlus to provide verification of the competence of each staff member, and counter-endorsements of trainees' competence records, it noted that the individual technical competence of staff was not in question.
IANZ said that in many cases the abilities and dedication of the technical and scientific personnel were of international repute and it was important for the future well-being of LabPlus that they continued to contribute to the service.
"However, the quality system failures apparent during this assessment will need to be rectified in order to ensure a sustainable recovery and the re-establishment of confidence in the quality of service provided by the laboratory," IANZ said.
rdDid IANZ find any problems other than those which led it to suspend LabPlus' accreditation? Yes. IANZ made several strong recommendations concerning parts of the laboratory's practice.
These recommendations are not essential for LabPlus to regain accreditation but are intended to help the organisation maintain an effective, quality service.
They include developing a policy that clearly defines where and when gloves should be worn, identifying the patients' toilet and providing amenities such as a disposal unit for women's sanitary towels.
Other recommendations included computerising the family history record system in the molecular genetics section, reviewing ventilation in the DNA extraction room, repairing a safety cabinet used by haematology staff, maintaining an up-to-date list of who has authorised access to the mortuary, and considering subscribing to the Journal of the Ultrastructural Pathology Society.
rdHave any of the improvements IANZ requires been made yet? Yes. More staff have been hired to tackle the problem of urgent tests taking too long.
However, it has been difficult to tell if the measures are effective because of the reduced number of patients in hospital over the holiday season.
The Auckland District Health Board expects to know by the middle of February if the extra staff are making a difference to turnaround times.
To address the problems surrounding documentation, the board has put a process in place that it says will revise all documentation according to company policy and IANZ requirements.
It also says it has ensured there can be no recurrence of the problem in future.
The board says it is committed to making whatever changes are necessary to restore confidence in the clinician-management relationship.
It was intended to be the biggest and best of medical laboratories. Health reporter MONIQUE DEVEREUX catalogues the faults that inspectors say LabPlus must fix first.
LabPlus combines 13 laboratories that used to be scattered around central Auckland's public hospitals.
Its specialist staff perform the widest spectrum of tests of any New
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