Application for Human Pathology Accreditation

  1. Laboratories not seeking DHS - Medicare Australia Recognition
  2. NEW laboratories seeking DHS - Medicare Australia accreditation
  3. An accredited laboratory seeking an extension to accreditation
  4. Renewal of Approved Pathology Laboratory (APL) licence for DHS - Medicare Australia for existing laboratories

For more information or to apply for Human Pathology Accreditation, contact NATA in Sydney on 02 9736 8222 or NATA in Melbourne on 03 9274 8200.

Laboratories not seeking DHS - Medicare Australia Recognition
Laboratories not seeking DHS - Medicare Australia recognition should follow the process outlined at How to become accredited.

NEW laboratories seeking approval as a recognised Approved Pathology Laboratory (DHS - Medicare Australia)
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), pursuant to section 23DN of the Act. An advisory visit MUST be conducted, as directed by DHS - Medicare Australia.  NATA requires at least 2 months advance 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. In brief, the process is as follows:


The laboratory must provide details of the proposed operations in writing, including:

  • Laboratory address
  • Proposed range of testing
  • Staff arrangements
  • NPAAC category; and
  • 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; and
  • 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.

Following the successful completion of an advisory visit and before claiming from DHS - Medicare Australia, the laboratory is required to submit a formal application to NATA (Application for Accreditation of a Laboratory) and pay the relevant application fee. Upon receipt of the application form and accompanying fee, a NATA/RCPA application number will be issued to the applicant together with a DHS - Medicare Australia Advisory report. This report recommends that an approval period of six months be approved by DHS - Medicare Australia for the payment of benefits.

Once issued with the report, the laboratory should apply to DHS - Medicare Australia for recognition as an Approved Pathology Laboratory (APL). The report must be submitted with the DHS - Medicare Australia application. Following approval by DHS - Medicare Australia, the laboratory is able to claim DHS - Medicare benefits.

An assessment will be conducted by NATA within the time frame discussed at the advisory visit, usually 3-5 months after the formal application to NATA. It should be noted that under our Deed with DHS, NATA can only issue a new Assessment report to replace the Advisory report once accreditation has been granted. Once issued the laboratory must forward this new Assessment report to DHS - Medicare Australia with their APL application.
The Assessment report will highlight whether NATA/RCPA accreditation is to be recommended, the length of time the recommendation covers and the Divisions (according to the DHS - Medicare Benefits Schedule) for which accreditation will be recommended.

It is acknowledged that an applicant laboratory may only have limited QC and QAP data (if any) to review at an initial assessment. It may be necessary for NATA to request further information post accreditation being granted, for example, end of cycle QAP summaries. The accreditation status may be reviewed in light of the new information supplied. If further information is requested (e.g. QC or QAP information) for review there may be additional processing costs. In most cases however this is likely to be reviewed at the next scheduled visit.

Where accreditation is not granted prior to the Advisory report expiring e.g. follow up visit required, laboratory not providing adequate submissions a new Assessment report for DHS - Medicare Australia cannot be issued. As a result the laboratory’s access to MBS funding may cease.

It is also acknowledged that a newly established laboratory may only be processing a low number of test requests however; laboratories must be cognisant of the fact that testing must be available for observation before an accreditation decision can be made regarding the capability and competence of the laboratory to meet the requirements for accreditation.

For more information or to apply for Human Pathology Accreditation, contact NATA in Sydney on 02 9736 8222 or NATA in Melbourne on 03 9274 8200.

An accredited laboratory seeking an extension to accreditation for new Divisions or a significant range of testing within a Division of the DHS - Medicare Benefits Schedule

If a laboratory wishes to commence testing in a new Division (as determined in the DHS - Medicare Benefits Schedule) or significantly different testing within a Division then it must advise NATA in writing of its intention.

Any requests for extensions must be assessed prior to NATA/RCPA accreditation or DHS - Medicare Australia approval being granted.

NATA will evaluate the request and, if necessary, request additional information for review (e.g. QC and QAP data). If these changes are not extensive, a desk-top review will be conducted and will attract a fee as per the NATA fee schedule. Depending on the nature of the addition DHS - Medicare Australia may be advised of the outcome of the review.

It is, however, usual practice for on-site assessments to be conducted on new Divisions and for significant extensions to the range of testing within a Division prior to extending NATA/RCPA accreditation. For example, if a laboratory is accredited for haematology and requests accreditation for the full range of immunohaematology tests, NATA would carry out an on-site assessment of the immunohaematology testing. If the assessment is conducted outside a routine reassessment or if additional Assessors are required at the routine assessment, a fee will be levied for the visit.

After a satisfactory assessment, a revised Assessment report will be issued detailing the new areas of testing. The laboratory should then submit the Assessment report to DHS - Medicare Australia.

For more information or to apply for Human Pathology Accreditation, contact NATA in Sydney on 02 9736 8222 or NATA in Melbourne on 03 9274 8200.

Renewal of Approved Pathology Laboratory (APL) licence for DHS - Medicare Australia for existing laboratories

An Assessment report is issued to each laboratory prior to expiry but can only be issued to laboratories who have complied with the surveillance intervals and requirements for accreditation and have had their accreditation continued.
Issues such as delays in assessment due to postponement by the laboratory, poor assessment outcomes; the need for follow up visits, incomplete submissions by the laboratory may result in NATA not being able to issue a new Assessment report.

The Assessment report:
details the period i.e. an expiry date, approved by DHS - Medicare Australia for the continuation of benefits. Generally, the approval period will be three years from the date of the reassessment (or two years and six months in the case of a new accreditation).

  • outlines the Divisions for which the laboratory holds accreditation. It may also list exclusions within the Divisions.
  • details the date of the most recent assessment activity. This will most often be the On-site visit but it may also be another type of visit such as an On-line activity.
  • Usually does not include the APP, APA and the name of the Proprietor. This information must be completed by the laboratory.

Where a follow-up assessment is deemed necessary for the whole laboratory a new Assessment report will not be issued until accreditation has been continued.

Where a follow-up assessment is deemed necessary for part of the laboratory a new Assessment report will be issued recommending approval for those areas unaffected by the scope of the follow-up. Those areas affected by the scope of the follow-up may have their recommendation revoked.

The laboratory will be issued with a further Assessment report once all corrective action has been verified and accreditation continued. This report will reflect the period for which accreditation has been continued.

Organisations with one APL, but with numerous departments or sections which may be assessed at different times and have various reassessment intervals, it should be noted that the expiry date will be determined by the department or section with the shortest accreditation interval.

For more information or to apply for Human Pathology Accreditation, contact NATA in Sydney on 02 9736 8222 or NATA in Melbourne on 03 9274 8200.