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INSTAND Termini e Condizioni Generali

General Terms and Conditions for Participation in INSTAND External Quality Assessment Schemes
(as per: 08/10/2020)

1. INSTAND e.V. – Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e. V. organizes external quality assessment schemes ("EQA schemes") according to the current Guidelines of the German Federal Medical Association (Bundesärztekammer) or in corresponding application of these Guidelines respectively.

2. Depending on the particular EQA scheme, the participation in EQA schemes encompasses the delivery of samples or enabling access to digital images (hereinafter jointly referred to as "test material") by INSTAND e.V., which the participant analyses either in his laboratory or his medical practice. The results of the analysis are to be entered in a protocol form by the participant, which is provided by INSTAND e.V. (paper-based or electronically) and shall be returned to INSTAND e.V. at the participant’s expense. INSTAND e.V. reviews the analysis results entered in the protocol forms and issues a certificate and a certificate of participation or only a certificate of participation to the participant according to Sec. 10 of these general terms and conditions.

3. The participation in INSTAND-surveys is open to everyone who conducts analysis in his own medical practice or in a laboratory headed by him. Participation requires prior registration of the participant on the INSTAND online platform (https://rv-online.instandev.de/) and proof of the prerequisites for participation (operation of a medical practice or laboratory; necessary handling permits for infectious material). The participant must keep his data (in particular the delivery, billing and certificate address) up to date at all times. Costs due to out-of-date data shall be borne by the participant.

4. The samples must be handled as if they were patient samples. In particular, all safety instructions on the accompanying documentation as well as the relevant legal requirements and professional duties of care for handling samples must be observed. Samples may only be used for testing in INSTAND EQA schemes and – in case of apparent test-immanent problems of certain in vitro diagnostic medical devices ("IVDs") – for inspection of the relevant IVD. Samples must not be misused for production of pathogens or pathogen moieties, neither for scientific nor commercial use. Samples must be disposed of properly.

5. For participation in EQA schemes, the participant must register online on the INSTAND platform (https://rv-online.instandev.de/).

6. The contract for the respective EQA scheme is concluded when INSTAND e.V. accepts the participant's registration for the respective EQA scheme ("Acceptance").

7. Before the EQA scheme is started, INSTAND e.V. is entitled to cancel it or to reasonably reschedule it, in the event of impossibility to perform the EQA scheme (e.g. if samples are not available). INSTAND e.V. will inform the participant and undertake reasonable efforts to offer a prompt alternative date for the realization of the EQA scheme.

8. Samples will be delivered by INSTAND e.V. Ex Works (Incoterms 2010) via a transport company chosen by INSTAND e.V. Dispatch dates are provided on the order confirmation. After the samples have been handed over to the transport company, the risk of loss or damage shall pass to the participant. The participant will inform INSTAND e.V. without undue delay in case the samples have not been received within one day of the respective dispatch date specified in the order confirmation. Transport costs, taxes and duties shall be borne by the participant. The participant is responsible for any necessary import permits. Costs for return transport or destruction of samples due to lack of import permits or refusal of acceptance shall be borne by the participant. Digital images will be made available to participants online. The protocol forms to be completed by the participants are either sent to the participants together with the samples or they are made available to the participants online.

9. Various aspects of the EQA scheme can be subcontracted by INSTAND e.V. In the event of subcontracting, the survey is conducted by subcontractors, who are bound by instructions and obliged to maintain confidentiality.

10. The deadline for returning the protocol forms, filled out by the participant, and for the online input of analysis results is specified in the EQA scheme program. Decisive for compliance with the deadline is the date on which the protocol forms were sent by the participant. The participant must prove that the protocol forms were sent in due time. The return of protocol forms by fax is not permitted. If the protocol forms are received within the deadline a certificate of successful participation will be issued, provided that the applicable requirements in each case are met. In addition, the participant will receive a certificate of participation in the EQA scheme. Participants who have submitted their analysis results on time but whose results do not comply with the applicable requirements will receive a certificate of participation in the EQA scheme.

11. The fees for participation in an EQA scheme are defined in the EQA scheme program. All prices are subject to the statutory value-added tax. INSTAND e.V. is entitled to refuse the participation in the EQA scheme as well as the delivery of the certificates if the participant is in default with his payment obligations. The payment obligation arises upon conclusion of the contract pursuant to Sec. 6 of these general terms and conditions. The payment obligation lapses only in case of payment by the participant pursuant to Sec. 12 of these general terms and conditions or cancellation of the EQA scheme by INSTAND e.V. pursuant to Sec. 7 of these general terms and conditions or in case the participant deregisters within the deadline as specified in the order confirmation.

12. The invoice will be issued after the delivery of the samples or after enabling access to the digital images. Invoice amounts are due within 30 days of receipt of invoice. Invoices are issued exclusively in EURO. The participant bears any and all potential bank fees that may be incurred.

13. Any complaints must be made within 4 weeks of receipt of the results of the EQA scheme. Upon expiration of this deadline the participant’s claims arising from complaints are excluded.

14. In the event of a justified complaint which INSTAND e.V. is liable for, INSTAND e.V. may at its sole discretion either waive its claim for fees or carry out an additional EQA scheme. Administrative and handling charges resulting from this, e.g. for reagents, time exposure etc., are non-refundable, to the extent that INSTAND e.V. is not liable according to Sec. 15 of these general terms and conditions.

15. INSTAND e.V. shall only be liable, regardless of the legal ground, for damage which has been caused as a result of negligent breach of a substantial contractual duty/cardinal obligation. Liability in terms of amount shall be limited to damage which is predictable and typical. Further liability of INSTAND e.V. is excluded. This limitation does not apply to liability for injury to life, body and health and in case of intentional and grossly negligent breach of obligations.

16. INSTAND e.V. complies with the provisions of the General Data Protection Regulation and the German Federal Data Protection Act. Details on data processing can be found in INSTAND e.V.'s data protection notice.

17. The place of performance is the registered office of INSTAND e.V. in Düsseldorf.

18. The laws of the Federal Republic of Germany shall apply to the contract exclusively with the exception of the Private International Law and the UN Sales Convention (CISG).

19. If the participant is a merchant in the meaning of sec. 1 (1) of the Handelsgesetzbuch (German Commercial Code) or is a legal entity (under public law) or special fund organized under public law, Düsseldorf shall be the place of jurisdiction in respect of all disputes arising out of or in connection with the contract.

20. Unless expressively otherwise agreed, only these general terms and conditions shall apply to the participation in INSTAND EQA schemes. Any general terms and conditions of the participant shall not apply, even if they have not been specifically rejected by INSTAND e.V.

21. Should an individual term of these general terms and conditions partially or completely be or become invalid or unenforceable, this shall not affect the validity of the remaining terms. The same shall apply in case of any omissions. Instead of the invalid, unenforceable or missing term, to the extent legally possible an appropriate term shall be deemed to have been agreed upon which is closest to what the parties economically intended or according to purpose to the agreement would have intended had they been aware of this point. The same shall apply to invalid terms which concern the scope or the time (deadline and date) of performance; in such a case, a legally permissible scope or time of performance shall be deemed to have been agreed upon which is closest to what the parties economically intended.