Clinical Chemistry - Thistle QA
Clinical Chemistry - Thistle QA
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