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Clinical Chemistry - Thistle QA

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P.O. Box 131375, Bryanston, 2074<br />

Ground Floor, Block 5<br />

Bryanston Gate, 170 Curzon Road<br />

Bryanston, Johannesburg, South Africa<br />

804 Flatrock, Buiten Street, Cape Town, 8001<br />

PARTICIPANT INSTRUCTIONS<br />

CHEMISTRY – CYCLE 51<br />

Expiry date: 2016-­‐11<br />

www.thistle.co.za<br />

Tel: +27 (011) 463 3260<br />

Fax: +27 (011) 463 3036<br />

Fax to Email: + 27 (0) 86-­‐557-­‐2232<br />

e-­‐mail : service@thistle.co.za<br />

PI-­‐009<br />

Please check your kit upon arrival and call <strong>Thistle</strong> immediately if there are any problems with your kit<br />

or samples. We will advise you on the correct protocol to follow.<br />

Introduction:<br />

Method questionnaires are available for all the international <strong>Thistle</strong> programmes. It is important to read and understand this<br />

document. If you have any queries please contact <strong>Thistle</strong> <strong>QA</strong> immediately for assistance.<br />

Method Questionnaire Instructions:<br />

This is available on our website or on request from <strong>Thistle</strong> <strong>QA</strong>.<br />

Method changes or new laboratories – take note of the information below:<br />

The method questionnaire should be completed and a copy retained by you for your records. Ensure that you complete the<br />

method questionnaire in full. Your details will help us to classify your results correctly and thus provide you with useful<br />

statistical data.<br />

The Method questionnaire consists of two separate documents:<br />

i. A list of laboratory analysers and supplier names, each with a numeric code, in order for you to select a code for<br />

each analyte. This document is called the Instrument and Suppliers list.<br />

ii.<br />

The method questionnaire, which indicates the method codes available for each parameter along with the standard<br />

unit indicated<br />

On the method questionnaire, for each parameter you run, please tick the method appropriate to your lab. State your<br />

instrument code, reagent code, and the units that you use in your laboratory only if they are different to the standard units<br />

indicated. If codes are not available for your assay, please state the details of your method clearly in the section at the end of<br />

the questionnaire.<br />

Characteristics:<br />

Your pack contains lyophilised 5ml samples of human serum. The vials are labelled with a cycle and sample number.<br />

Factors that could influence the testing of the sample<br />

Important: Vials must be stored at 2-­‐8 °C<br />

Do not shake the vial.<br />

After reconstitution, it is stable for 2 days at 2 -­‐ 8 °C in the absence of bacterial contamination with the exception of the<br />

parameters below.<br />

Prostatic & Total Acid Phosphatase: The samples can be stabilised by adding 1 drop of acetic acid to 1ml of serum.<br />

Bilirubin in the serum is light sensitive and it is recommended that the serum be stored in the dark before measurement.<br />

NEFA is stable for 24 hours at 2 – 8°C following reconstitution.<br />

Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components.<br />

Please treat as a routine patient sample<br />

Preparation:<br />

1. The samples are sealed under vacuum. Open each vial carefully, avoiding any loss of material and using a calibrated<br />

pipette reconstitute with an accurately measured 5ml volume of freshly double distilled water at 20°C to 25°C.<br />

2. Replace the rubber stopper and ensure that samples are completely dissolved by swirling gently, allow to stand at<br />

room temperature for 60 minutes out of bright light before use. Do not shake the vial.<br />

<strong>Thistle</strong> <strong>QA</strong> is a SANAS accredited organisation, No: PTS0001<br />

Accredited to ISO 17043<br />

Certificate available on request or at www.sanas.co.za Page 1 of 2


P.O. Box 131375, Bryanston, 2074<br />

Ground Floor, Block 5<br />

Bryanston Gate, 170 Curzon Road<br />

Bryanston, Johannesburg, South Africa<br />

804 Flatrock, Buiten Street, Cape Town, 8001<br />

www.thistle.co.za<br />

Tel: +27 (011) 463 3260<br />

Fax: +27 (011) 463 3036<br />

Fax to Email: + 27 (0) 86-­‐557-­‐2232<br />

e-­‐mail : service@thistle.co.za<br />

PI-­‐009<br />

Safety:<br />

Warning: Potentially Biohazardous Material<br />

The serum is human based. It has been source tested and found to be negative for HBsAg and antibodies to HIV and HCV. For<br />

complete protection however, it is recommended that the serum be handled as carefully as patient samples. Dispose of used<br />

samples as you would routine patient samples.<br />

Return of Results:<br />

Each of the samples has a number printed on the label. We recommend analysis dates as shown below. Please send your<br />

results -­‐ at the latest -­‐ on the final cut-­‐off dates given below. If the recommended analysis date does not allow you to get<br />

results to us on time, please analyse earlier. Use the correct dates for the sample numbers in the kit sent to your laboratory.<br />

If in doubt, please contact <strong>Thistle</strong> immediately for assistance. Please note that no results will be accepted after the FINAL cut-­off<br />

date.<br />

Additional Notes:<br />

Web site submission is available – please enter via web site using the user name and password given to you by <strong>Thistle</strong> <strong>QA</strong>.<br />

EDI system users must work through their relevant <strong>QA</strong> Divisions to ensure that results are imported in due time.<br />

The reports will be posted / e-­‐mailed within 7-­‐ 10 working days after the FINAL cut-­‐off date.<br />

Collusion and/or falsification of E<strong>QA</strong> results are not good accreditation practice.<br />

Return Dates for Results<br />

CHEMISTRY<br />

Sample No: Analysis Dates: Final Cut-­‐off Dates:<br />

1 15 September 2014 22 September 2014<br />

2 29 September 2014 06 October 2014<br />

3 13 October 2014 20 October 2014<br />

4 27 October 2014 03 November 2014<br />

5 10 November 2014 17 November 2014<br />

6 24 November 2014 01 December 2014<br />

7 08 December 2014 15 December 2014<br />

8 22 December 2014 29 December 2014<br />

9 05 January 2015 12 January 2015<br />

10 19 January 2015 26 January 2015<br />

11 02 February 2015 09 February 2015<br />

12 16 February 2015 23 February 2015<br />

13 02 March 2015 09 March 2015<br />

<strong>Thistle</strong> <strong>QA</strong> is a SANAS accredited organisation, No: PTS0001<br />

Accredited to ISO 17043<br />

Certificate available on request or at www.sanas.co.za Page 2 of 2

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