NATA


Information for Facilities Regarding Accreditation to AS/NZS 4308:2008 and AS 4760:2006 for On-site Collection and Drug Screening

NATA is pleased to offer accreditation for facilities involved in the collection and on-site testing of specimens for drugs of abuse in urine and oral fluid to AS/NZS 4308:2008 and AS 4760:2006 respectively. Accreditation can be tailored to meet those particular sections of the toxicology Standard relevant to the service being provided.

This document gives facilities involved in on-site (workplace) toxicology services information about NATA's proposed accreditation process for this area of testing. This document includes only the major points about which facilities may have concerns.

Costings
Cost will be dependent upon the size and complexity of the service provided. It is likely that this will involve a tailored fee structure and assessment plan for each facility. It is envisaged the assessment cycle will cover a 3 year period.

Standards Requirements
The facility must comply with all aspects of the relevant toxicology standards for which accreditation is sought;

In addition, the facility must comply with relevant sections of AS 4633:2004 (ISO 15189:2003) Medical Laboratories - Particular requirements for quality and competence - see Appendix 1;

It may be applicable for some facilities to be accredited to ISO 17025-2005 General requirements for the competence of testing and calibration laboratories rather than AS 4633:2004 (ISO 15189:2003).

Assessment process
Where requested, an advisory visit will be conducted to explain the accreditation process, requirements for accreditation and any concerns the facility may have. This activity will be chargeable at the current rate as described in the NATA Fee Schedule available from the NATA website;

For a multi-site accreditation the initial assessment will generally be conducted at the main corporate site to review documentation and records. Where applicable, this will be followed by a review of the overall service covering a percentage of the facility's collection sites. These site visits will review collection and testing procedures;

An assessment report will be generated after the initial assessment visit. Any issues identified in the report will need to be addressed before accreditation can be recommended and granted.

Technical and training requirements
In accordance with the AS/NZS 4308, all on-site testing devices must be verified as fit-for-purpose by a laboratory accredited to ISO/IEC 17025 or AS 4633 and the relevant standard i.e. AS/NZS 4208;

It is acknowledged that the quality and drug cut-off levels of testing devices vary considerably. The facility will only be accredited for the device(s) it was using at the time of assessment and for which a verification procedure was performed by an accredited laboratory. This will be reflected on the facility's Scope of Accreditation (SoA). If further devices are required to be included in the SoA, product verification must be submitted for review;

In accordance with the standard, all collectors require a certificate of attainment from the Australian Quality Training Framework or New Zealand Qualification Authority, which will need to be sighted at the assessment visit;

Where an appropriate Quality Assurance Program (QAP) exists in Australia, the facility needs to enroll for each matrix for which accreditation is sought, i.e. Urine and/or Oral fluid. There will not be a requirement for each collector or collection site to be enrolled separately in a QAP. Where such a program is not available, the collecting agency must arrange a program with another facility to demonstrate on-going reliability of the screening process;

Each type of testing device used must be enrolled in a QAP;

QAP must be undertaken by each collector on a rotational basis;

The facility must have a means of monitoring the performance of all collectors on an ongoing basis;

Oral fluid devices and quality controls (QC) MUST be targeted to Delta9 THC NOT Carboxy THC.

Once accreditation has been granted, the facility will receive a certificate of accreditation and a SoA. The SoA will include reference to AS 4633:2004 (ISO 15189:2003) Medical Laboratories - Particular requirements for quality and competence and the relevant sections of AS/NZS 4308:2008 and AS 4760:2006 as set out below:

This facility complies with the requirements of AS 4633:2004 (ISO 15189:2003)

10.60 Chemical pathology

10.61 General chemistry

.17 Drugs for toxicological purposes to AS/NZ 4308:2008
Section 2 Specimen collection, storage, handling
and dispatch
or
Section 2 (including Appendix A) Specimen
collection, storage, handling,
dispatch and on-site screening procedure

.18 Drugs for toxicological purposes to AS 4760:2006
Section 2 Collection, storage, handling and
dispatch Section 3 On-site initial testing 

Appendix 1
This is designed to give facilities an indication of the relevant sections of AS 4633:2004 (ISO 15189:2003) Medical Laboratories - Particular requirements for quality and competence with which they will be required to comply in addition to the relevant section of the toxicology standard.

4 Management requirements
The complexity of the Quality Management System (QMS) should reflect the complexity of the facility and its operations. NATA would not generally expect such facilities to have a QMS as complex as a "traditional" pathology organisation.

4.1 Organisation and Management
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.2 Quality Management System
All aspects of 4.2.1, 4.2.2, 4.2.3 and 4.2.4 are required in the context of the size, scope and complexity of the facility.

4.2.5 to be considered and included, where relevant.

4.3 Document control
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.4 Review of contracts
Review of contracts is required on at least a periodic basis.

Generally request forms are not presented at time of collection.

There are known pre-analytical issues with relation to collection devices, e.g. false negative results caused by drugs adhering to plastic components or adulterants in the mouth prior to testing.

The facility must demonstrate an understanding of the limitations of the screening devices and that clients have been advised in some way. This could be in the form of an information sheet or on the report itself.

NATA is aware that much of the information is 'commercial-in-confidence', i.e. financial arrangements, blind random sampling etc. NATA will not request such information as part of the assessment process. However, whatever these arrangements are, they must not compromise compliance with the relevant standard.

Should any procedures or administrative arrangements contravene the relevant standard, the laboratory cannot claim compliance for these activities. Examples of this may be the use of an on-site testing device which has a different cut-off from that stipulated in the standard or the reporting of non-negative screens which have not been confirmed.

4.5 Examination by referral laboratories
All aspects of this clause are required in the context of the size, scope and complexity of the facility. The only testing likely to be referred is confirmatory testing from a non-negative on-site screen which must be performed by a laboratory that is accredited to the relevant standard.

4.6 External services and supplies
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.7 Advisory services
In accordance with the standard, the facility is required to have access to an expert who has appropriate training and experience in applications of analytical toxicology.

4.8 Resolution of Complaints
All aspects of this clause are required in the context of the size, scope and complexity of the facility. The facility must have procedures for recording, actioning and closing-out complaints.

4.9 Identification and control of nonconformities
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.10 Corrective action
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.11 Preventive action
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.12 Continual improvement
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.13 Quality and technical records
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.14 Internal audits
All aspects of this clause are required in the context of the size, scope and complexity of the facility.

4.15 Management review
All aspects of 4.15.1, 4.15.2, 4.15.4 of this clause are required in the context of the size, scope and complexity of the facility. 4.15.3 is not applicable.

5 Technical Requirements

5.1 Personnel
5.1.1 All aspects of this clause are required in the context of the size, scope and complexity of the facility.
5.1.2 Training records and certificate of attainment from AQTF or NZQA.
5.1.3 - 5.1.13 all aspects of these clauses are required in the context of the size, scope and complexity of the facility.

5.2.1 Accommodation & environmental conditions
5.2.1 - 5.2.7 Accommodation set aside for collection facilities are site specific for the workplace to be visited. The accommodation must not compromise the security, integrity or performance of the collection or testing process.
5.2.8 All aspects of this clause are required in the context of the size, scope and complexity of the facility.
5.2.9 Storage of specimens for confirmation, QC and QAP must be considered.
5.2.10 All aspects of this clause are required in the context of the size, scope and complexity of the facility.

5.3 Laboratory Equipment
Very limited equipment is required. NATA will review this section in the context of the testing to be undertaken.

5.4 Pre-examination Procedures
In accordance with the toxicology standard, specimens are screened immediately in the presence of the donor, therefore no labelling is generally required. Collection and labelling of specimens for referral will be as per the relevant toxicology standard. "Traditional" labelling requirements, as defined in the Medical Testing Field Application Document, for referred specimens still apply. All referred specimens must be clearly traceable back to the donor.

Traditional request forms are generally not supplied. This is non-Medicare related testing.

It is important to note the pre-analytical limitations of collection and testing devices. These must be understood by the collection facility and this information must be made clear to the requesting authority. The manner in which this is provided will be reviewed at assessment (See Contract Review).

5.5 Examination procedures
All aspects apply in the context of the testing.

All testing devices for urine must be initially verified as per Appendix B of AS/NZS 4308:2008.

Although it is acknowledged that AS 4760:2006 does not contain such an appendix, similar verification procedures as described in AS/NZS 4308:2008 Appendix B will be expected for testing devices for oral fluid.

Any significant modification (e.g. change of manufacturing site, change of cut-off), to the testing devices must be re-validated by the manufacturer and re-verified by an accredited laboratory as defined above. Any information regarding changes to these devices must be kept by the collection facility. NATA will review performance at assessment.

5.6 Assuring quality of examination procedures
The relevant toxicology standard refers to the procedures required for QC and QAP assessment. All clauses generally apply in the context of the testing. Investigation and corrective action in the event of failed QC and QAP is essential and will be assessed by NATA.

5.7 Post-examination procedures
The relevant toxicology standard refers to procedures for referring samples post-testing.

5.8 Reporting of results
See the relevant toxicology standard for instructions on reporting procedures. The facility must reconcile screening results obtained on-site with the confirmatory results generated by the referral laboratory.

Generally reports can be released on forms produced by the collection facility and can be hand-written, especially if a negative result is returned. The NATA accreditation number must be included on the test report. A copy of all results must be maintained by the collection facility.

Should you have any questions please do not hesitate to contact

Mr Andrew Griffin
Deputy Sector Manager, Life Sciences
NATA
Level 1, 675 Victoria Street
Abbotsford VIC 3067
Ph (03) 9274 8200
E-mail This email address is being protected from spambots. You need JavaScript enabled to view it.

or Mr Neil Shepherd
Sector Manager, Life Sciences
NATA
Level 1, 675 Victoria Street
Abbotsford VIC 3067
Ph (03) 9274 8200
E-mail This email address is being protected from spambots. You need JavaScript enabled to view it.

19 February 2013