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

1.2 By accepting a request the LDGA undertakes to perform the requested work with due care and professionalism within the relevant quality criteria of the LDGA.

1.3 Requests may be rejected by the LDGA if they include insufficient information to ensure that a result meets the quality criteria defined by the LDGA. In such cases the LDGA will immediately inform the applicant.

1.4 Where indicated, tests will be conducted on two independent samples. When unavailable, the laboratory will carry out tests on a single sample and include a disclaimer with the result. If a request is made to confirm the result, subsequent tests will be billed. 

1.5  Application forms forwarded from another laboratory. The LDGA accepts blood or DNA, accompanied by an application form. The LDGA 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. The referring laboratory will also receive a cc of the results for their own records.

1.6  Application forms for further testing following an incidental finding or as confirmation. This request is treated by the LDGA 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 referring laboratory will also receive a cc of the results for their own records.

1.7  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.

1.8 The tests offered within our application forms are accredited by the Accreditation Council in accordance with ISO15189: 2012; See Scope M007: List of tests LDGA

2. Samples

2.1 Samples submitted by the applicant to the LDGA must include two unique identifiers (name or patient number and date of birth) 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 ldga@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 LDGA refusing to accept a sample and/or carry out testing.

3. Procedure

3.1 The LDGA 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 LDGA.

3.3 When a request is received that requires (additional) work in a field in which the LDGA has no experience, the LDGA 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 LDGA.

4. Reporting

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

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

4.3 Results as reported by the LDGA relate to the material and information received by the laboratory. The LDGA 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 LDGA will describe this in the report. Outsourcing takes place in accordance with the relevant accreditation requirements of the LDGA.

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 LDGA 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 anonymised 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 LDGA will request that the referring doctor or other healthcare professional inform the patient accordingly (see patient information on the last page of the request form). 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 2, June 11 2015