Application to Participate

An invitation to participate in any given round of QA is distributed at the beginning of the year. This document details the diseases to be covered in that round of QA as well as the costs of participating.

Analytes and questions

For the full interpretative schemes, currently two distributions of samples are made in a given year, the first in June/July and the second in early August. The single deadline for report submission is late September giving the participants 12 and 6 weeks respectively to complete the work.

For all other schemes, contact the Scheme Organiser for key dates.

Participants are informed in advance of the date of dispatch of samples and should be ready to take receipt of the samples. If samples do not arrive then it is the participants responsibility to inform the Scheme Organiser. In which case all possible measures will be taken to distribute repeat aliquots and documentation as soon as possible.

For the practical exercises in any given round of QA sufficient DNA is usually supplied to perform all necessary analyses plus a modest number of repeat analyses. The DNA provided is stable at +4°C. However long-term storage at -40°C is recommended. A small amount of repeat DNA samples are usually available from the Scheme Organiser on request. DNA for the scheme is obtained from either normal volunteers or from patients through special arrangements with collaborating physicians or participating laboratories.

The material used for the practical schemes resembles as closely as possible the relevant clinical material routinely tested in the participating laboratories, such as DNA or blood spots.

The materials distributed are provided as specimens for the sole purpose of enabling external quality assessment at the recipient's laboratory during the current distribution and must not be tested for any other disease than that which is requested by the EQA scheme. They do not constitute in vitro medical diagnostic devices (IVDs), and no claim is made that they may be suitable for any other purpose or at any other point in time.

Reporting Results

Centres are asked to provide full interpretative reports in their normal laboratory style. All returns should be anonymous and identified solely by their individual laboratory reference number.

Participants of Genotyping only schemes are required to submit their results using a web-based form.

All returns should be submitted by the laboratories via their own account on the website.

Any centre that does not provide returns on or before the given deadline without having made a satisfactory arrangement with the Scheme Organiser will be deemed a poor performer due to non-participation.

Scoring

Reports are marked by the member of the Steering Committee responsible for setting the investigations. If no member of the Committee is qualified to set the cases for a given disease then an expert from outside the Committee will be co-opted to sit on the Committee for that year. All scoring is independently checked by a second expert who may or may not sit on the Committee. Any discrepancy in the two sets of marking are resolved by the full Committee.

Scoring is divided into three categories, genotyping, interpretation and clerical accuracy each marked out of 2.0 marks according to criteria agreed by the Steering Committee.

The Annual Report

Performance scores of individual participating centres along with markers' comments are distributed with a general overview of the scheme shortly after the deadline for returns. This enables participants to review their own performance in the light of their results as quickly as possible and make any necessary changes to their practices.

Poor Performance

The criteria for poor performance and persistent poor performance are given in the document 'Poor Performance Criteria'.

Performance scores and relevant raw data may be shared with the relevant Advisory Panel under defined circumstances (see the Poor Performance Criteria).

Appeals

Participants who feel they have a legitimate claim against the scores they have received are given a period of time to submit a written appeal to the Scheme Organiser. This appeal will be presented to the full Steering Committee who will make a final decision.

Final Scores

A complete set of performance scores for all participating centres is distributed upon completion of the appeals procedure. Only their unique reference number identifies participants.

Location, Administration and Communications

The UK NEQAS for Molecular Genetics is administered from within the Northern Genetics Service at the Institute of Human Genetics based at the International Centre for Life, Newcastle upon Tyne. Confidential communications should be made through the Scheme Organiser by email, in writing, fax or by phone. More general points may be made through the scheme chairperson (see contact information). All correspondence with the Scheme Organiser will be kept for a period of six years.

Eligibility

The Molecular Genetics full intrepretative QA scheme is available to all laboratories, public and private, within the U.K., The Republic of Ireland and The Netherlands. Other laboratories may be able to participate in separate EQA schemes run in collaboration with other bodies.  Please contact the Scheme Organiser for further information. Participating laboratories must be aware of the conditions of participation and must agree to abide by the rules of the scheme.

Enrolment Procedure

Laboratories who have not previously participated in the UK NEQAS for Molecular Genetics must inform the Scheme Organiser in writing of their desire to participate. Participating labs will be allotted a unique laboratory reference number in each round of the QA, which must be quoted in all correspondence with the Scheme Organiser.

Charges

The cost of participating in the UKNEQAS For Molecular Genetics scheme is subject to fluctuation. Current costs can be obtained from the scheme organiser on request.

Refunds

 Refunds are only payable under exceptional circumstances.

Confidentiality

The fact of participation, raw data and performance scores are confidential between the individual laboratory and the scheme organiser (and in exceptional circumstances the Chair of the Steering Committee). Performance scores and relevant raw data may be shared with the relevant Advisory Panel under defined circumstances (see the Poor Performance Criteria).

UK NEQAS reports are copyright and may not be copied, distributed, published or used for publicity and promotion in any form without the written consent of the relevant Scheme Organiser on each and every occasion. Participating centres may themselves choose to share details of their individual performance with clients (e.g. GPs, clinicians) without consultation with the scheme organiser. UK NEQAS participant codes should not be disclosed to third parties.

Steering Committee Membership and Second Markers

The UKNEQAS for Molecular Genetics is always looking for volunteers to sit on the Steering Committee or act as second markers. Anyone interested in taking a more active roll in the running of the scheme is strongly encouraged to contact the Scheme Organiser for more details.

Feedback

Comments about the scheme are welcome at any time and should be made in writing to the scheme organiser. Feedback questionnaires are frequently used to poll opinions and to assist in developing the scheme according to participants needs. In addition an annual user group meeting is held at the CMGS spring meeting and participants are encouraged to attend.

Complaints Procedure

Most complaints received by UK NEQAS schemes consist of minor misunderstandings or problems with specimens that can usually be resolved over the telephone with the scheme organiser. In addition the Scheme Organiser can be emialed via the scheme email (info@ukneqas-molgen.org) for the purposes of informal feedback.

Participants who feel that their cause for complaint requires a more considered response should communicate their concerns immediately to the Scheme Organiser in writing. A preliminary telephone call may assist in clarifying the issue and establishing the requisite action. Upon receipt of the complaint the communication is logged along with the action taken. If the scheme organiser feels it appropriate then he/she will attempt to address the complaint as soon as possible by letter. If not the participant will be made aware of the situation and given the date of the next Steering Committee meeting at which the matter will be discussed. Similarly if the participant is not satisfied with the response by the Scheme Organiser then the matter will be brought before the full Committee at their next meeting. In these instances a response will be made in the light of advice from the Committee.

In the event of continued dissatisfaction the Scheme Organiser will seek advice and assistance in resolving the matter from the appropriate Advisory Panel.


Updated: 02/06/2008 Sandi Deans

History: 13/08/2007 SD; 22/06/2006 SD