NATA


Frequently Asked Questions


 

General Questions

How do you determine whether a facility has met an action with 'Met with Merit'? This is defined by the Commission as ‘in addition to achieving the actions required, measures of good quality and a higher level of achievement are evident. This would mean a culture of safety, evaluation and improvement is evident throughout the organisation in relation to the action or standard under review’
How much time is allocated for assessments to the NSQHS Standards? It is expected that this activity would take ½ day to one day. Pilot assessments are going to be conducted to assist in this determination.
If a facility requests N/A status who determines this to be applicable? Every item, criteria or Standard which is determined as N/A by a facility must be submitted to NATA with supporting evidence or an argument as to why it is considered N/A. Each request will be reviewed and if we support the claim that it is N/A, we will forward it to the Commission for approval.
When the Standard is due for revision in 2017 is it expected that developmental items will become core? It is considered that this could occur at any stage.
The document highlighting which actions are core and which are developmental is a separate document that has varying applicability across different health service organisations (e.g. day procedures centres, dental practices etc.).
The actual Standards document does not differentiate between the core and developmental actions.
Will assessing to the NSQHS be site specific as per Medicare? Yes. The NSQHS Standards need to be assessed as applicable at the local level.
The services we assess will be in different hospitals and may be in different jurisdictions even if they are the same corporate organisation. As such the local procedures and processes will differ and we need to assess implementation at this local level.

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Standard 1 Governance

What needs to be documented? This is detailed in the Standard. Also the workbook includes the table of what procedures are required to be available.
Do we look at hospital Board meeting records? It depends on how the department being assessed is integrated into the hospital and the associated reporting requirements.
We will need to ask about the relationship with the hospital and reviewing evidence of how information is provided to Board meetings.
What is an 'open disclosure policy'? Open disclosure is defined by the Commission as the “open discussion of incidents that result in harm to a patient while receiving health care with the patient, their family, carers and other support persons. The essential elements of open disclosure are outlined in the national Australian Open Disclosure Framework”.
Further information is included in the references section of the NSQHS Standards.
Turn-around times and re-collections are examples of quality and safety indicators used in pathology. Is there a need for reporting to management? Yes, these indicators are required to be reported depending on the policies of the hospital on which indicators require reporting. This would likely also include mismatches in patient identification as a safety indicator.

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Standard 3 Healthcare infections

Is item 3.1 applicable to the clinical settings only or does it also apply to the laboratories? Item 3.1 would be applicable to all settings as it is about assessing risk to patients. However, the risks would be quite different between pathology and a clinical environment.
Antimicrobial stewardship program - what is this? This is defined by the Commission as “A program implemented in a health service organisation to reduce the risks associated with increasing microbial resistance and to extend the effectiveness of antimicrobial treatments. Antimicrobial stewardship may incorporate a broad range of strategies including the monitoring and reviews of antimicrobial use”.

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Standard 5 Patient Identification

What is the extent of applicability given that the ID bands are provided by the wards and not our services? Even though pathology are not responsible for the provision of ID bands, they have a responsibility to advise the hospital where they do not comply with the NSQHS Standards.

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Standard 6 Clinical Handover

Does Clinical Handover need to involve the patient? Clinical Handover is the process of providing handover of care between staff and is not required to be conducted in the presence of the patient. Clinical Handover can vary depending on patient circumstances, and items to consider include:
  • Shift change and transfer of urgent processing e.g. Pathology
  • Face to Face e.g. Imaging
  • Staff areas e.g. Sleep

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Accreditation for Branch or Project Sites

For information on how to become a NATA accredited facility, please visit how to become accredited.

The links provided below are relevant only for existing accreditations that are seeking to establish an additional branch or project site.

 

  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:

FlowCahrt


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.
 

Reports issued by NATA-accredited facilities

A test report, calibration certificate, or any similar document serves as a statement on the activities performed, the results of these activities and, where necessary, may include relevant information required to interpret these results. Hereafter, these documents shall simply be referred to as 'reports'.

Note: Certain fields or programs do not allow the inclusion of interpretations and opinions on reports. Refer to the relevant Application Documents available from the Publications section.

For further information, see Policy Circular 18.

The NATA Endorsement

NATA-accredited facilities are encouraged to apply the NATA endorsement on reports for results on activities covered under their scope of accreditation. However, not all NATA facilities may issue endorsed reports on all occasions. For example, if a facility's client requests testing only on activities outside its scope of accreditation (that is, outside the range of activities for which they have been specifically accredited by NATA) then the facility is NOT permitted to apply the NATA endorsement.

An endorsed report may, however, contain results on activities that fall outside the facility's scope of accreditation, or results from other facilities, so long as these results are clearly identified as such (and the report at least includes results on activities for which the facility holds accreditation).

Where results from another accredited facility are included, the following additional information must be added:

a) identification of the accredited facility by the name in which accreditation is held and the accreditation number; and
b) endorsed report/document identification.

What MUST be included in a NATA report?

Reports from accredited facilities must include the information prescribed in the relevant international standard against which the facility is accredited e.g. ISO/IEC 17025 for testing and calibration activities, ISO 15189 for medical testing facilities, ISO/IEC 17020 for inspection, ISO Guide 34 for reference material producers, and ISO/IEC 17043.

Different fields and programs may have different and/or additional reporting requirements. These are included in the relevant Field Application Documents.

What about calibration certificates?

Calibration certificates (calibration reports) from accredited facilities must include the information prescribed in the relevant international standard against which the facility is accredited. For example, ISO/IEC 17025 for calibration activities, and in the relevant Field Application Documents.

What if there is no endorsement on the report?

The same requirements apply for activities performed under a facility's scope of accreditation, regardless of whether an endorsed report is issued or not. As mentioned previously, use of the endorsement is optional.

Can a facility issue a preliminary report?

Preliminary reports (however named) may be issued when components of a test or suite of tests have not yet been completed. However, those results which are reported must be checked and authorised and the status of the report evident i.e. preliminary. This includes reports which are accessible to an enquirer electronically.

Where an accredited facility issues a preliminary report prior to the final report, the final report shall contain a reference to the preliminary report.

No report, whether preliminary or final, shall include results which have not been authorised for release.

What about reports from Verifying Authorities?

NATA accredited facilities that have been appointed as Verifying Authorities by the National Measurement Institute of Australia (NMI) must comply with reporting, calibration and test method requirements of NMI where relevant, and hold Regulation 13 certificates for their reference equipment. Such facilities should contact NMI to ensure that they are aware of current requirements for Verifying Authorities.

What if the facility has subcontracted the activity to another facility?

When the report contains results of tests performed by subcontractors, these results should be clearly identified.

When a calibration has been subcontracted, the facility performing the work must issue the calibration certificate to the contracting facility.

What if the facility wishes to amend my report or calibration certificate?

Material amendments to a report or calibration certificate after they have been issued must be made only in the form of a further document, which includes the statement:

"Supplement to Test Report [or Calibration Certificate], serial number ... [or as otherwise identified]",

or an equivalent form of wording.

When it is necessary for the facility to issue a complete new report or calibration certificate, they must uniquely identify the new report and include a reference to the original that it replaces.

Where can I get more information?

If you have any further questions about a report you have received from a NATA accredited facility, please do not hesitate to contact your nearest NATA office.

NATA provides accreditation for a wide range of testing facilities and similar bodies in such areas as pathology, diagnostic imaging, the environment, food, waters, pharmaceuticals, concrete, asbestos, toxicology, electrical equipment, IT, biotechnology, metallurgy, plastics, nuclear medicine, and many more.

NATA can also tailor its service to meet the needs of particular organisations. Indeed, NATA has a strong record of developing specialist accreditation programs for particular industry or professional needs.

More information on the process of accreditation can be found in How to become accredited.

NATA currently operates accreditation programs in more than 18 different fields and programs, including:

  • Biological Testing
  • Calibration
  • Chemical Testing
  • Construction Materials Testing
  • Forensic Science
  • Information and Communications Technology
  • Inspection
  • Mechanical Testing
  • Medical Imaging
  • Diagnostic Imaging
  • Medical Testing
  • Non-Destructive Testing
  • Performance and Approvals Testing
  • Proficiency Testing Scheme Providers
  • Recognition - Good Laboratory Practice
  • Reference Material Producers
  • Research and Development
  • Sleep Disorders Services
  • Veterinary Testing

Biological Testing

Testing in the food, water and pharmaceutical industries is essential to maintaining preventative health measures. Biological Testing accreditation gives facilities the assurance that their technical processes meet world-recognised standards. The program also includes areas such as plant health, which is ideal for quarantine and government facilities as well as private industries that deal with plants and plant products.

Calibration

NATA’s accreditation in calibration includes all calibration activities covering the parameters of Dimensional metrology, Mass and Mass related quantities, Electrical metrology, Temperature metrology, Optical metrology, Radiometry, Acoustic calibrations and Vibration calibration. Chemical calibrations and metrology are accredited under the field Chemical Testing.

Chemical Testing

Chemical testing accreditation is available to any facility that undertakes tests in areas that include metals and ores, cement and concrete, asbestos, fuels and lubricants, surface coatings, plastics, foods, agricultural products, and residues in the environment. Chemical Testing also covers calibration facilities in the areas of gas analysers for the mining and OH&S industries as well as breathalysers.

Construction Materials Testing

Construction materials accreditation is available for any facility that tests construction materials for building, road works, infrastructure and other uses. These tests include cement and clay-based products, bitumous materials, soils, surfaces, road-marking materials and rocks and aggregates.
Construction materials accreditation is ideal for road authorities, quarries, private companies and plants that produce bricks, cement or pavers.

Forensic Science Module

NATA's Forensic Science Module provides facilities with a means of establishing sample integrity through chain of custody procedures and court testimony capability. It is ideal for facilities that are exposed to legal and regulatory processes.

Information and Communications Technology

NATA's Information and Communications Technology field provides accreditation for a diverse range of software and hardware testing in such areas as gaming systems, information security evaluations and healthcare software.

Inspection

Through its inspection accreditation program, NATA provides inspection bodies with a means of demonstrating to their customers their superior inspection skills and commitment to professional excellence.
NATA inspection accreditation is available to all inspection services including in-house and independent services, from one-person operations to large-scale inspection bodies.
More information on the process of accreditation and ISO/IEC 17020 can be found in Inspection Accreditation.

Mechanical Testing

Mechanical testing accreditation covers facilities that perform the physical testing of materials and products such as metals, plastics, rubber, textiles, timber, lifting gear, pipes, valves and automotive products.

Medical Imaging

The RANZCR/NATA Medical Imaging accreditation program was launched in 2004 and is jointly administered by NATA and the Royal Australian and New Zealand College of Radiologists (RANZCR).

The RANZCR/NATA program offers accreditation to sites in accordance with the RANZCR Standards of Practice for Diagnostic and Interventional Radiology. Demonstration of compliance is through a peer review process which includes on-site review. The program is open to all types of diagnostic imaging services and covers the modalities of general radiography, ultrasound, mammography, computerised tomography, interventional radiology, magnetic resonance imaging, nuclear medicine and bone mineral densitometry.

All facilities accredited under NATA's Medical Imaging accreditation scheme are automatically recognised by the Commonwealth Department of Health and Aging (DoHA) as meeting its compulsory Diagnostic Imaging Accreditation Scheme requirements.

Diagnostic Imaging Accreditation Scheme

NATA is an approved accreditor under the Commonwealth Government’s Diagnostic Imaging Accreditation Scheme.  Facilities must be assessed against the Diagnostic Imaging Accreditation Scheme Standards in order to be eligible to provide Medicare-funded services for any item under the Diagnostic Imaging Services Table (DIST) of the Medicare Benefits Schedule.

Medical Testing

The medical testing accreditation program is administered by NATA in conjunction with the Royal College of Pathologists of Australasia (RCPA).
NATA/RCPA accreditation to ISO 15189 is available to facilities performing tests in various fields of human pathology including anatomical pathology (histology and cytology), chemical pathology, microbiology, haematology, immunohaematology, cytogenetics, molecular biology, immunology and assisted reproductive technologies. The program also offers accreditation for a limited range of samples of non-human origin.
Medicare rebates for eligible pathology tests are only available to facilities holding accreditation in this field.

Non-Destructive Testing

Non-destructive testing (NDT) covers a diverse range of techniques designed for assessing the integrity of materials, most typically metals.  Applications include evaluating compliance of fabricated items with material specifications and identifying degradation which can occur during the service life of equipment or structures.  In addition to recognised NDT techniques, accreditation for limited applications of thermography and vibration analysis (which are regarded as Condition Monitoring techniques), is offered within NATA's NDT accreditation program.

Performance and Approvals Testing

The field of Performance and Approvals Testing covers primarily consumer product type testing, plus testing in the areas of fire resistance, thermal properties, high voltage and high current, lighting, sound and vibration.

Providers of Proficiency Testing Schemes

NATA accreditation of proficiency testing scheme providers enables organisations that are interested in planning, providing and evaluating proficiency testing schemes to achieve and demonstrate a level of competence.

The program provides the international testing and calibration community with a fully functional and operational system of accredited providers of proficiency testing schemes conforming to international criteria.

Full details can be found under Proficiency Testing Scheme Provider Accreditation.

Recognition of Compliance with the OECD Principles of Good Laboratory Practice

NATA makes this available to any facility doing non-clinical environmental health and safety studies required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, veterinary drug products and similar products, and for the regulation of industrial chemicals.

For more information, see OECD Principles of GLP Recognition.

Reference Materials Producers

Reference materials with certified values are widely used for the calibration of measuring instruments and for the evaluation or validation of measurement and testing procedures. Their use makes possible the transfer of the values measured (or quantities assigned) between testing, analytical and measurement facilities.

Research and Development

The benefits of research and development accreditation include a potential reduction in client audits, evidence of appropriate procedures and systems in place to satisfy funding body requirements, and greater confidence in results from organisations carrying out sub-contracted research and development activities.

Sleep Disorders Services

The Sleep Disorders Services accreditation program was launched in 2012 and is jointly administered by NATA and the Australasian Sleep Association (ASA).
The NATA/ASA program offers accreditation to services in accordance with the ASA Standard for Sleep Disorders Services. Demonstration of compliance is through a peer review process which includes on-site review. The program is open to all types of sleep disorders services and covers comprehensive Tier 1 services through to Tier 3 Diagnostic Services.

Veterinary Testing

Veterinary testing covers facilities that test animals and animal products for the diagnosis, monitoring and treatment of disease. The field can accommodate government and private facilities, veterinary practices and university veterinary schools.

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