Application

Applications for accreditation may be made by any legally identifiable organisation and must be made on the appropriate application form. Further information on this process is available in the article "How to apply for RANZCR/NATA Accreditation" referred to above and available on the NATA website.

When applying for accreditation, an Authorised Representative will need to be nominated. This person is the site's representative in all matters relating to its application and subsequent accreditation (once gained). At a practical level, the Authorised Representative is normally a senior staff member who is in a position to make decisions concerning the site's accreditation and to effectively communicate with practice colleagues. However, recognising that the Authorised Representative is not necessarily the most appropriate person to answer day to day and technical queries regarding the site's activities, a 'Contact' person for the site is also requested to be nominated. Often, the Authorised Representative and the 'Contact' are the same person.

Advisory Visit

An advisory visit is conducted by a NATA staff officer where the accreditation requirements and the process involved in gaining accreditation can be discussed. The aim is to ensure that the site is ready to proceed with its application for accreditation and thus minimise follow-up activities after the initial assessment which adds time to the process and costs.

It is stressed that an advisory visit does not constitute a technical review of the site as this can only be achieved by the technical assessors during the actual assessment.

Advisory visits may be conducted either prior to, or after, an application has been made. The most appropriate timing for such a visit will be a matter for negotiation between the site and RANZCR/NATA, however, it is strongly advised that such a visit be conducted prior to the application. Fees are payable for the advisory visit.

Document Review

Prior to an assessment, the site will be requested to provide to NATA a copy of the completed Assessment Information Document (AID) and a copy of its Quality Manual and associated documentation for review. The latter activity is known as a 'document review' and is the first part of the formal examination of the site. The document review provides a comparison of the site's Quality Manual and associated documentation and procedures with the accreditation requirements. The NATA staff officer, also known as the lead assessor, assigned to manage the application, will make note of particular references within the site's documentation that require review or further explanation. Written feedback will be provided. Depending on the extent of the action required, the site may be asked to provide further information prior to the assessment or this information will be sought at the assessment. A fee will be levied for the document review.

Organising the Initial Assessment

The purpose of the initial assessment is to assess compliance of the site with the RANZCR/NATA Accreditation Requirements which includes ISO/IEC 17025 "General Requirements for the competence of testing and calibration laboratories", ISO/IEC 17025 Application Document: Supplementary requirements for accreditation of medical Imaging services (which incorporates the RANZCR Accreditation Standards for Diagnostic and Interventional Radiology) and any other relevant statutory and regulatory requirements.

The NATA lead assessor coordinating the assessment will contact the Authorised Representative approximately 6 - 8 weeks before the initial assessment to discuss logistics such as preferred times and dates and to propose an assessment team.

The assessment team is headed by the NATA lead assessor. It is ensured that the technical assessors invited on the assessment team can cover both the reporting and procedural aspects for each modality. Thus it can be expected that at least one radiologist / medical specialist and one technologist / sonographer will be on each assessment team in addition to the NATA officer. First and foremost, the assessment is a peer review process.

The NATA lead assessor coordinates the team and reviews the site's management system. Additionally, the lead assessor provides advice on precedents, ensures consistency is maintained between assessments and is responsible for gathering the assessors comments, delivering the findings to the site and preparing the written report.

Assessors are selected according to their breadth of expertise and are matched as closely to the activities of the site as possible. Consideration is given by the NATA officer to a number of issues when the assessment team is being composed which may include:

• the size of the site including the modalities offered;
• the complexity of the examinations performed;
• the history of the assessors ie. where they have worked and which sites they have assessed before;
• personal associations the assessors may have;
• the availability of the assessors;
• the geographical location of the site and the assessors.

Ultimately, the size of the assessment team and the number of days on-site is dependent upon the modalities and complexity of the examinations that must be covered in the course of the assessment. Larger teams on any given day are not favoured, even though such teams may reduce the time spent on-site. Larger teams are more disruptive to the site by altering workflow due to 'congestion', the need to review 'œmore' in less time and requiring staff to make themselves more available. Further, to gather comments from smaller teams ie two or three assessors, is a simpler task and allows time to discuss findings with the NATA officer.

Conflict of interest with regard to commercial issues is appreciated and the NATA Rules specify that a site may refuse up to three of the proposed assessors. It must be noted that all assessors must sign a confidentiality agreement and that any information reviewed on-site will only relate to the accreditation requirements. An additional role of the NATA officer is to ensure that other information is not viewed by the assessors.

Once a date and assessment team is finalised, the technical assessors are provided with 'Briefing Notes' that give background information on the site. These notes include a copy of the completed AID and, where necessary, a copy of the relevant sections of the site's Quality Manual, for example an organisation chart.

The Assessment Day

A typical time table for an assessment day may be as follows.

8:15am: Assessment Team Meeting

Preliminary meeting with the assessment team to discuss / clarify roles and areas to be examined by each member.

8:30am: Entry Meeting

An entry meeting with the Authorised Representative, senior staff and the assessment team. The purpose of this meeting is to:

• introduce the site's staff and the assessment team;
• clarify the day's agenda;
• clarify the services provided by the site ie. 'Scope of Accreditation';
• determine any changes since the Assessment Information Document (AID) was submitted;
• clarify the organisational and staffing structure of the site.

9:00am Review of Patient Reception

Includes patient booking procedures, patient identification, patient preparation, patient facilities, and associated documented procedures.

10:00am Review of examination procedures

The assessment team splits and commences reviewing procedures. Review includes:

• discussions with relevant staff (including medical, technical and trainee staff);
• appropriateness of facilities;
• appropriateness of procedures and availability of documentation eg. manuals;
• equipment maintenance and calibrations;
• quality control procedures;
• dealing with problems (corrective actions);
• etc.

The assessors will also wish to view examinations being performed. The NATA lead assessor will discuss management system issues with the quality manager (or quality representative on-site) and review quality related records including internal audits, management review, corrective action and purchasing to name a few.

13:00pm Lunch break.

13:30pm

The assessment team continues its review of manuals, RANZCR Image Review records, and any other documentation not viewed previously. In general, assessors will wish to retire to a quiet area to review the documented procedures and records.

15:00pm Assessment team meeting

The lead assessor and assessors discuss their findings, including the emphasis to place on issues raised.

The assessors prepare their written findings and the NATA lead assessor collates these findings into a written interim report (a copy of which will be left with the site at the end of the assessment).

16:15pm Exit Meeting

The interim report is presented to the site. It is the prerogative of the site to decide which of their staff should attend this meeting. Generally, the Authorised Representative and senior staff would be expected to attend. During the meeting, sites are strongly encouraged to clarify issues they consider may have been misunderstood by the assessment team and to seek clarification about assessment findings where this may be necessary.

17:00pm Close

Assessment team departs!

The Assessment Report

For assessments conducted over a number of days, an exit meeting is generally held on each day, however, a copy of the interim report will not be available until the last day.

The report details the findings of the assessment team. Each comment will be referenced against the relevant clause number from ISO/IEC 17025 and graded as a condition or an observation. Codes used in assessment reports are C, M or O.

A Condition (coded as "C") represents:

• a direct contribution to the reliability of the image / patient report or the potential to compromise the image / patient report; or
• a systematic problem ie. it is not random.

Examples of "C" are calibration deficiencies, inadequate quality control practices or staff inexperience. All "C" must be addressed and evidence of this provided by the site prior to accreditation being granted.

A Minor Condition (coded as "M"):

• does not contribute directly to the reliability of the image / patient report; or
• is a random breakdown or lapse in practice.

An example of an "M" is where training records of staff have not been kept up to date but training has been provided for critical tasks. A response on action taken or intended will be required for an "M" but evidence of this will not be sought for accredited practices. Confirmation that the issue has been addressed will be followed up at the next reassessment.

For applicant organisations, both "C"s and "M"s must be addressed and evidence of action taken provided, prior to accreditation being granted.

An observation (coded as "O") may include recommendations for improvement.

After the Assessment

After the assessment, the findings of the assessment team are confirmed in a formal report which has been reviewed by NATA and, where necessary, the Medical Imaging Accreditation Advisory Committee (AAC). The confirmed report will detail the action required by the site before a recommendation to grant accreditation will be considered by the AAC.

Generally, sites are expected to submit documentary evidence of the corrective actions that have been implemented to address issues within 4 weeks of receiving the confirmed report.

Where numerous or significant issues have been raised at the assessment, the AAC may determine that a follow-up visit is required prior to the granting of accreditation. Generally, such visits will concentrate on the areas of concern highlighted at the original assessment, however, this may not always be the case and a complete follow-up assessment may be required.

Granting Accreditation

A recommendation is made by the Medical Imaging AAC to the RANZCR Council and NATA's Board once a site has met all the requirements for accreditation. In general, this final review process can take up to 6 weeks. The Authorised Representative is formally advised of the granting of accreditation and issued with a certificate of accreditation and the scope of accreditation.

The scopes of accreditation of all RANZCR/NATA accredited practices are available on the NATA website.

After Accreditation

RANZCR/NATA accredited practices must continue to comply with all accreditation requirements. In order to ensure continued compliance with these requirements, reassessments are carried out every three years after accreditation. Shorter reassessment intervals may also be specified by the AAC. The reassessment follows the same processes and has the same broad objectives as the initial assessment.

Assessments may also be conducted after substantial changes to staff, other resources, procedures or when a change to the scope of accreditation is requested by the site eg. addition of new modalities or procedures.

Confidentiality

All information provided by a practice in connection with an enquiry or an application for accreditation, and all information obtained in connection with an assessment, is treated as confidential by NATA staff, technical assessors, the Medical Imaging AAC, RANZCR Council members and NATA's Board. All such personnel are made aware of this requirement and have signed confidentiality agreements.

Disclosure of Personal Information by Applicant and Accredited Practices at Assessments

In order for RANZCR/NATA to determine compliance with some accreditation criteria, it will be necessary to sight personal information at assessments. Examples might include personal information held in training records, complaints records, lists of approved suppliers etc. It is the responsibility of the site to ensure that, in accordance with the National Privacy Principle 1.3(d), it has appropriate arrangements in place to advise individuals that personal information collected may be disclosed to RANZCR/NATA.