Criteria for laboratory diagnostics

1. Requests
2. Samples
3. Procedure
4. Reporting
5. Confidentiality
6. Use of patient material

1.Requests 

1.1  In order to avoid mistakes and delays, requests should be submitted in a clear and unambiguous manner. Always use the most recent version of the request form. Use of the request form ensures that all necessary information is provided. The form is available via page Requests for laboratory diagnostics.

• By accepting a request, the GD undertakes to perform the requested work with due care and professionalism within the relevant quality criteria of the GD.
• Requests may be rejected by the GD if they include insufficient information to ensure that a result meets the quality criteria defined by the GD. In such cases the GD will immediately inform the applicant.
• Application forms forwarded from another laboratory. The GD accepts blood or DNA, accompanied by an application form. The GD only accepts requests from a physician. The physician is responsible for informing the patient about the genetic testing procedure. The physician is the applicant and will receive the results.
• Application forms for further testing following an incidental finding or as confirmation. This request is treated by the GD as a new application. The physician informs the patient about the possibility that further genetic tests may be required. The physician is the applicant and will receive the results.
• The applicant is via the application form and the therein contained reference to our website fully informed of our application procedure and the criteria set out by us.
• The tests offered within our application forms are accredited by the Accreditation Council in accordance with ISO15189: 2012; See Scope M007: (scope is in Dutch).

2. Samples

2.1   Samples submitted by the applicant to the GD must include at least two unique identifiers (name or patient number, date of birth /or BSN ) and a completed request form.

2.2   Blood and other substances that can be sent at room temperature should be packed and shipped in accordance with regulations UN3373 and packing instruction P650 (ADR), together with the request form. For frozen material, please enquire (phone 071 526 9800 or via genoomdiagnostiek@lumc.nl ) so that we can guarantee appropriate receipt and storage. Prenatal samples should always be sent by courier after making arrangements with the laboratory.

2.3  Failure to comply with 2.1 and 2.2 may result in the GD refusing to accept a sample and/or carry out testing.

3. Procedure

3.1   The GD will determine the manner, method and apparatus with which work is performed.

3.2   All work will be performed in accordance with explicit and appropriate norms, standards and rules. On request, the applicant will be provided with this information by the GD. 

3.3   When a request is received that requires (additional) work in a field in which the GD has no experience, the GD will discuss the outsourcing of such activities with the applicant.

3.4   All activities and storage prior to the receipt of a specimen fall outside the responsibility of the GD.

 4.  Reporting

4.1   All results, whether test results, advice, information, or in any other form whatsoever, will be communicated by the GD in writing.

4.2   For the turnaround times of the various procedures, please refer to our website.

4.3   Results as reported by the GD relate to the material and information received by the laboratory. The GD assumes no responsibility for errors in sampling, identification of the received material and - where relevant - family relationships, as supplied by the client.

4.4 When tests concerned with the implementation of testing are outsourced, the GD will describe this in the report. Outsourcing takes place in accordance with the relevant accreditation requirements of the GD.

 5. Confidentiality

5.1   Confidentiality of personal data is guaranteed and laid down in the hospital regulations of the LUMC (confidentiality of patient data). When processing personal data, the LUMC acts in accordance with the Data Protection Act.

 6. Use of patient material

6.1   When no other arrangements were specified during the original request for diagnostic testing, the GD will store patient biological material or the remnants and/or isolates from the material remaining after testing, in accordance with its own regulations.

6.2   The patient or his legal representatives can submit a written request for the destruction of samples.

6.3 The use of coded biological material may be helpful when developing and improving analytical methods (control samples and validation) and for further research related to the original diagnostic question. Any further use of human tissue within the Department of Clinical Genetics complies with the guidelines of the Code for Proper Use by the Federation of Medical Scientific Societies (FMWV) and, where applicable, the local Medical Ethics Committee. The GD will request that the referring doctor or other healthcare professional inform the patient accordingly. In cases where the further use of biological material results in findings relevant to the patient, they will be informed via the original referring doctor/healthcare professional. 

Version 3.1
December 2024