Application for Medical Accreditation

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

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

Laboratories not seeking Medicare Australia Recognition.

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

NEW laboratories seeking approval as a recognised Approved Pathology Laboratory (Medicare Australia)

A new laboratory seeking accreditation must approach NATA for an advisory visit prior to applying for approval with Medicare Australia, pursuant to section 23DN of the Act. An advisory visit MUST be conducted, as directed by 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:

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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; and
  • Evidence of QAP enrolment

At the advisory visit the NATA lead assessor will providean 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 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 Medicare Australia "Report on Laboratory Premises" (hereafter called "the Report"). This Report recommends that an approval period of six months be approved by Medicare Australia for the payment of benefits.

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

An assessment will be conducted by NATA within the time frame discussed at the advisory visit, usually 4-5 months after the formal application to NATA. If the findings of the initial assessment are satisfactory, NATA will supply a Report based on the assessment findings.  The laboratory must forward this Report to Medicare Australia within 6 months of the applicant's formal application to NATA.  The Report will highlight whether NATA/RCPA accreditation is to be recommended, the length of time recommended before the next assessment visit and the Divisions (according to the Medicare Benefits Schedule) for which accreditation will be recommended.

It should be noted that an applicant laboratory will 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, for example, the end of year QAP summaries. The accreditation status may be reviewed in light of the new information supplied. If further information is requested (eg QC or QAP information) for review there may be additional processing costs.

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 a decision can be made regarding the capability of the laboratory to meet the requirements for accreditation.

For more information or to apply for Medical Testing 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 Medicare Benefits Schedule

If a laboratory wishes to commence testing in a new Division (as determined in the 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 Medicare Australia approval being granted.

NATA will evaluate the request and, if necessary, request additional information for review (eg 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. Medicare Australia will 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. Similarly if a laboratory is accredited for non-gynaecological cytology and requests accreditation for gynaecological cytology it would be necessary to conduct an on-site assessment of the gynaecological cytology service. 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 Report will be issued detailing the new areas of testing. The laboratory should then submit the Report to Medicare Australia.

For more information or to apply for Medical Testing 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 Medicare Australia for existing laboratories

A Report is issued to each laboratory after each reassessment.  Reports are only issued to laboratories who have complied with the surveillance intervals and requirements for accreditation. Delays in assessment due to postponement by the laboratory may result in NATA not being able to issue a Report until an assessment has been conducted.

The Report:

  • details the period ie. an expiry date, approved by Medicare Australia for the continuation of benefits, as determined by the reassessment interval set by NATA. Generally, the approval period will be three years from the date of the reassessment (or two years 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 assessment visit but it may be another type of visit if an assessment has not been conducted in the last 3 years.
  • may not include the APP, APA and APL numbers and the name of the Proprietor. This information must be completed by the laboratory.

Where a follow-up assessment is deemed necessary, the recommended approval period will be six months. The laboratory will be issued with a further Report once all corrective action has been verified. 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, should note that the expiry date will be determined by the department or section with the shortest accreditation interval.

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