National Association of Testing Authorities, Australia

NATA

Home Accreditation Types of Accreditation

Welcome to 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.

Top 


 

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.

Top 


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”.

Top


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.

Top 


 

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

Top 

NATA is pleased to announce that it has been approved by the Australian Commission on Safety and Quality in Healthcare (ACSQHC) to provide assessments to the National Safety and Quality Health Service (NSQHS) Standards.

Download NSQHS Standards flyer

NSQHS Standards Background

The ACSQHC developed the NSQHS Standards to improve the quality of health service provision in Australia.

The National Standards were endorsed by Australian Health Ministers in 2011 and provide a clear statement about the level of care consumers can expect from Health Service Organisations. Public hospitals, day procedures services and public dental clinics are now required to be accredited to the NSQHS Standards. Some States and Territories have also determined that additional health services (e.g. private hospitals) will be required to be accredited to these standards.

The NSQHS Standards

There are 10 NSQHS Standards focusing on areas that are essential to drive the implementation and use of safety and quality systems:

  1. Governance for Safety and Quality in Health Service Organisations 
  2. Partnering with Consumers 
  3. Preventing and Controlling Healthcare Associated Infections 
  4. Medication Safety
  5. Patient Identification and Procedure Matching 
  6. Clinical Handover
  7. Blood and Blood Products 
  8. Preventing and Managing Pressure Injuries 
  9. Recognising and Responding to Clinical Deterioration in Acute Health Care 
  10. Preventing Falls and Harm from Falls 

The NSQHS Standards, together with additional information and resources on the Standards, are available directly from the ACSQHC website www.safetyandquality.gov.au

Assessment to the NSQHS Standards

NATA will offer accreditation to the NSQHS Standards to complement our current health accreditation activities, including pathology laboratories and their associated collection services, medical and diagnostic imaging services and sleep disorders services. Assessments will be coordinated with current NATA assessment visits and will operate on a four yearly assessment cycle.

Fee Schedule

Facilities assessed against the NSQHS Standards will be charged at an hourly rate.  Please refer to our current fee schedule.

Contact us

For further information on assessment to the NSQHS Standards please contact our highly qualified and experienced staff on 1800 621 666 or via  This email address is being protected from spambots. You need JavaScript enabled to view it.

Frequently Asked Questions

A list of frequently asked question is available here. This will continue to be updated as the program progresses.

 


NHQHS

NSQHS

NSQHS

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 ILAC Guide 13 for proficiency testing scheme providers.

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.

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.
 

Inspection AAC Meeting 20 November 2014 Inspection AAC Meeting 20 November 2014
The 14th Inspection Accreditation Advisory Committee meeting will take place on 20 November 2014. The…
 
Latest Edition of NATA News Latest Edition of NATA News
The August Issue of NATA News is now available on the website. This issue contains:…
 
The winners of our 2014 World Accreditation Day competition have been announced The winners of our 2014 World Accreditation Day competition have been announced
The winners of our 2014 World Accreditation Day competition have been announced. They are:
 
NATA's Membership is being consulted on significant changes to NATA's governance NATA's Membership is being consulted on significant changes to NATA's governance
At last year’s Annual General Meeting (AGM) the NATA Membership voted in favour of several…
 
Technical Assessors News May 2014 Technical Assessors News May 2014
May issue of Technical Assessors News is now published online on the NATA website.
 
Home Accreditation Types of Accreditation