Guidelines for Drugs of Abuse Testing vers 2012 - Brenneisen
Guidelines for Drugs of Abuse Testing vers 2012 - Brenneisen
Guidelines for Drugs of Abuse Testing vers 2012 - Brenneisen
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12.2.2 Result<br />
Detection by immunochemical methods:<br />
• Name <strong>of</strong> the single substance or substance group 1<br />
• Interpretation 1<br />
• Name <strong>of</strong> the reference substance 2<br />
• Cut-<strong>of</strong>f <strong>for</strong> the reference substance 2<br />
• Obtained reading 2<br />
• Details about substances screened <strong>for</strong> but not found 1<br />
• Details about substances detected but not listed on the order <strong>for</strong>m 2 .<br />
Confirmation analyses (chromatographic methods):<br />
• Name(s) <strong>of</strong> single substances found 1<br />
• Obtained reading 2<br />
• Limits <strong>of</strong> detection 2 , cut-<strong>of</strong>f 2<br />
• Details <strong>of</strong> any measurement inaccuracies 2<br />
• Findings (Chapter 10) 2<br />
• Details about substances detected but not listed on the order <strong>for</strong>m 2 .<br />
12.2.3 Administrative Data<br />
• Date <strong>of</strong> sample collection and/or receipt <strong>of</strong> order 1<br />
• Date <strong>of</strong> report (date when transmitted) 1<br />
• Date <strong>of</strong> analysis 2<br />
• Signature <strong>of</strong> the person responsible <strong>for</strong> the release <strong>of</strong> the report (may be in electronic <strong>for</strong>m as<br />
well) 1<br />
• How transmitted (e.g., by phone, fax, email) 2<br />
• Reference to any copies 1<br />
• Reference to invoicing 2<br />
• Address <strong>of</strong> the laboratory (address <strong>for</strong> queries) 1 .<br />
1 Compulsory in<strong>for</strong>mation<br />
2 Optional in<strong>for</strong>mation<br />
12.3 Archiving<br />
All data listed under secs. 12.1 and 12.2 must be archived by the client (chapter 12.1, Order <strong>for</strong> an<br />
Analysis) and the laboratory (chapter 12.2, Report).<br />
The data (order <strong>for</strong>ms, extracts from the quality manual, measurement protocols, quality controls,<br />
calibrations, reports) must be archived in such a way that it is possible to obtain a copy <strong>of</strong> the<br />
analysis report at all times. Electronic storage media (e.g., CD-ROM or magnetic storage media)<br />
must be given preference over classic methods <strong>of</strong> archiving (on paper).<br />
12.3.1 Data Retention Period<br />
Data <strong>of</strong> an exclusively clinical nature must be kept <strong>for</strong> a minimum <strong>of</strong> 5 years (unless otherwise<br />
specified). Data protection criteria and the instructions issued by QUALAB shall also apply<br />
(Chapter 15).<br />
Data <strong>of</strong> a <strong>for</strong>ensic nature must be kept <strong>for</strong> a minimum <strong>of</strong> 10 years, unless explicitly directed by the<br />
authorities to destroy them or render them anonymous at an earlier date.<br />
13. Priority <strong>of</strong> the Results<br />
The priority status <strong>for</strong> obtaining results is broken down into three levels <strong>of</strong> priority, as shown in<br />
Table 12:<br />
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