1. The application process for NEW laboratories seeking Medicare Australia accreditation
2. The process for an accredited laboratory seeking an extension to accreditation
3. 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 9329 1633.

1. The application process for NEW laboratories seeking approval as a recognised Approved Pathology Laboratory (Medicare Australia)

See also: Flowchart for laboratories seeking accreditation (PDF, 29kb)

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. This step will provide a much higher level of accountability and assurance that the laboratory in question should be granted approval under section 23DN of the Act. NATA would prefer to be given at least 2 months advance notice to organise an advisory visit.

At the time of the initial inquiry, NATA staff will outline the process of both the advisory visit and assessment, including the timing of the advisory visit and subsequent assessment. An advisory visit MUST be conducted, as directed by Medicare Australia.

The laboratory must provide details of the following in writing:

• 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 being performed
• Appropriate staffing (in line with NPAAC requirements)
• Equipment; and
• Evidence of QAP enrolment
  

At the advisory visit the NATA staff officer will provide a questionnaire for completion and submission prior to the assessment. The staff officer will discuss the timing of the return of the completed questionnaire and the submission of the laboratory’s quality manual for review. The laboratory is not entitled to claim benefits at this time.

Following the 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). Upon receipt of this application, 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 considered 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. NATA will supply a Report based on the assessment findings to be forwarded 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 for which accreditation will be recommended.

Following receipt of the Report, Medicare Australia will extend its approval in line with NATA’s recommendations.

It should be noted that an applicant laboratory will only have limited QC and QAP data (if any) to review at an assessment 4-5 months after commencing pathology testing services. 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 for a newly established laboratory, the service provision may not be at a high level by the time of the assessment, i.e. the test request numbers are low. Nevertheless, laboratories must be cognisant of the fact that for a decision to be made regarding the capability of the laboratory to meet the requirements for accreditation there must be testing occurring which is able to be reviewed. There must therefore be provision for samples to be available for testing to demonstrate the operation of the laboratory.

For more information or to apply for Medical Testing Accreditation, contact NATA in Sydney on 02 9736 8222 or NATA in Melbourne on 03 9329 1633.

2. The application process for 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 in this regard.

Any requests for extensions must be evaluated/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 published 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 visit 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.

The on-site assessment will need to be carried out prior to Medicare Australia extending its approval for the new tests. If the assessment is to be conducted outside the routine surveillance interval then the laboratory will be charged for this, again in line with the published fees. (Often requests for additional tests can be incorporated as part of the routine surveillance program at no additional cost to the laboratory.)

Following assessment by NATA, a Report is issued to the laboratory which is then submitted to Medicare Australia for consideration of an extension to the range of tests currently approved.

For more information or to apply for Medical Testing Accreditation, contact NATA in Sydney on 02 9736 8222 or NATA in Melbourne on 03 9329 1633.

3. Renewal of Approved Pathology Laboratory (APL) licence for Medicare Australia for existing laboratories

Once a laboratory is recognised as an Approved Pathology Laboratory, the period approved by Medicare Australia for the continuation of benefits is determined by the reassessment interval set by NATA following the routine reassessment.

Generally, the approval period will be three years from the date of the reassessment (or two years in the case of a new accreditation). This will be indicated in the Report which is issued following the assessment and the receipt of a satisfactory response to the report. Laboratories also receive a formal report on the assessment detailing the findings of the review.

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.

NATA may not have some of the information required by Medicare Australia such as the APP, APA and APL numbers and the name of the Proprietor. This information must therefore be completed on the Report by the laboratory.

The Report will also outline the divisions for which the laboratory holds accreditation. It may also list exclusions within the divisions.

The Report will detail 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.

The Report will also detail the expiry date for payment of Medicare Australia benefits.

Reports will only be issued for those 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.

Laboratories should contact the NATA office 6 months prior to the next scheduled assessment to ensure that assessment arrangements are in progress. The due date of the next assessment is advised in the Notification Letter to the Authorised Representative confirming the granting or continuation of accreditation. This date is also displayed on the website at the end of the laboratory's scope of accreditation.

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 9329 1633.