Accredited Pathology Laboratories

For your laboratory to be approved as an Accredited Pathology Laboratory (APL), it must:

• be owned and operated by a current Approved Pathology Authority (APA)
• have an advisory or assessment report from the National Association of Testing Authorities, Australia (NATA) recommending Medicare accreditation
• submit an Application for approval, amendment or renewal of premises as an accredited pathology laboratory form (HW010) requesting approval for the laboratory category and groups of testing recommended by NATA
• pay the accreditation fee.

Although it’s not mandatory to provide the details of an Approved Pathology Practitioner (APP) to gain approval, your APL must have at least one APP to claim Medicare benefits.

Read more about NATA accreditation procedures on the NATA website.

How to apply

You need to get an advisory or assessment report from NATA recommending your laboratory for Medicare accreditation before applying for an APL. We’ll reject any application without a NATA report.

The National Pathology Accreditation Advisory Council (NPAAC) sets the laboratory quality standards, including laboratory category definitions. NATA is responsible for ensuring each laboratory meets these standards before recommending approval by us.

Find out more about Resources for the pathology standards on the Australian Commission on Safety and Quality in Health Care website.

To apply:

• fill in the Application for approval, amendment or renewal of premises as an accredited pathology laboratory form (HW010)
• for new approvals make sure the time between when you sign the application and send it to us is less than 3 months
• for renewal applications make sure the dates you sign the application and send it are no more than 3 months before your current approval expires
• upload your application through Health Professional Online Services (HPOS) along with the Advisory or Assessment Report from NATA or mail or fax your application to us.

New APL approvals begin from the day they’re approved by a delegate and can’t be backdated. NATA accreditation doesn’t grant access to Medicare benefits.

The NATA report must recommend the same laboratory category and pathology services in your application or your application will be rejected.

Read more about using HPOS.

Backdated approvals

If you apply late we can consider backdating your approval on a case-by-case basis, except when:

• the approval is for a new APL or new pathology services
• approval is granted by the delegate more than one month after the previous approval expired
• we don’t have enough information to make a decision.

To request a backdated approval, you need to provide all of the following:

• a correctly completed application
• a NATA report which supports your application
• a letter of request telling us why your application is late and the reason the approval should be backdated. This letter must be signed if it is not submitted by an authorised person using form upload.

We’ll consider backdating requests after:

• we approve the premises in principle
• you’ve paid the accreditation fee as requested.

We’ll consider the circumstances and let you know the outcome.

What happens next

If approved in principle, we’ll send you a letter and email (if provided) with a unique APL number asking for you to pay the fee.

Once we receive your payment, we’ll:

• grant full approval
• send you confirmation along with your approval dates.

We’ll remind you to renew your APL 3 months before it expires and you’ll need to allow enough time for processing. To do this:

• complete the Application for approval, amendment or renewal of premises as an accredited pathology laboratory form (HW010)
• submit the most recent NATA Assessment Report with the form.

If approved, your APL will be valid for up to 3 years.

When your circumstances change

You must obtain a new NATA Report and submit it with a new APL application if there’s a change to any of the following:

• your laboratory’s location
• your laboratory’s APL category
• NATA’s recommendation about your APL’s eligibility to perform pathology services.

You need to notify us in writing if you’re closing your laboratory.

You can do this by either submitting an:

• Application for approval, amendment or renewal of premises as an accredited pathology laboratory form (HW010)
• appropriately authorised and signed letter using HPOS Form upload.

Any new approval will be eligible from the date we approve it and can’t be backdated. This includes new APLs created due to relocation and new groups of testing approved for existing APLs.

If ownership of the laboratory changes, you must tell us at least 30 days before the change or Medicare eligibility may be affected. You can do this by completing the Approved Pathology Authority acquisition or merger advice form (HW036).