ISO 15189 Human Pathology

The primary objective of ISO 15189 is to provide a framework that medical laboratories must adopt to underpin their activities to ensure the validity and reliability of their testing services on patient samples. This in turn promotes better health outcomes for the patients whose medical care is dependent on these results. This includes the diagnosis, management, prevention, and treatment of disease.

The accreditation process itself involves an independent assessment of the medical laboratory’s pre-analytical, analytical and post analytical processes. This includes review of personnel qualifications and competence, equipment, test methods, reagents and supplies, quality control and assurance procedures, and reporting of results.

ISO 15189 accreditation covers all areas of pathology testing conducted in a “traditional” laboratory or in a “Point of Care” setting.

The accreditation of medical laboratories improves patient outcomes through the provision of valid and reliable test results. This is enhanced by laboratories required to have systems in place for monitoring and addressing errors in the pre-analytical, analytical and post analytical processes as part of the continual improvement process.

There are also advantages to accreditation for laboratories operating a number of sites at the national level, as it allows for standardisation of policies and processes resulting in efficiency gains.

NATA’s accreditation program for medical laboratories is delivered in collaboration with the Royal College of Pathologists of Australasia (RCPA). In addition to ISO 15189, the program adopts the relevant National Pathology Accreditation Advisory Council (NPAAC) standards as applicable to any given laboratory’s services.

NPAAC advises the Commonwealth, state and territory health ministers on matters relating to the accreditation of pathology laboratories. NPAAC also plays a key role in ensuring the quality of Australian pathology services and is responsible for the development and maintenance of standards and guidelines for pathology practices.

The NATA/RCPA program is recognised as the mandatory accreditation pathway for laboratories to allow Medicare payments to be claimed for pathology services.

A new laboratory seeking accreditation must approach NATA for an advisory visit prior to applying for approval with DHS – Medicare Australia as an Approved Pathology Laboratory (APL).

An advisory visit MUST be conducted, as directed by DHS – Medicare Australia.  NATA will require at least 2 month’s notice to organise an advisory visit.

At the time of the initial enquiry, NATA staff will outline the process of both the advisory visit and assessment, including the timing of both visits.

As part of the process, the laboratory must provide details of the proposed operations including:

• Proposed range of testing
• Staff arrangements
• NPAAC category 
• Commencement date

At the time of the advisory visit the laboratory must have in place:

• Facilities appropriate for the testing performed
• Appropriate staffing (in line with NPAAC requirements)
• All equipment required for testing with appropriate validation/verification data
• Evidence of QAP enrolment where available or alternate arrangements where a QAP is not available

At the advisory visit the NATA Lead Assessor will provide an Assessment Information Document (AID) for completion and submission prior to the assessment. The lead assessor will also provide an application form. The Lead Assessor will discuss the timing of the return of the completed AID and the submission of the laboratory’s quality manual for review.

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