Customer Service Agreement (CSA): Frequently Asked Questions (FAQ)
Why do I need to sign the CSA?
The CSA ensures that the Customers are informed about the Genome Center policy and all relations between the Customer and the Genome Center are clearly defined, agreed and signed. Furthermore, under ISO 15189 guidelines, a CSA is required for all accredited services.
The main text of the agreement presents the Genome Center's generic terms and conditions for the service. These conditions are primarily based on our policy and/or accreditation requirements. Legally, the CSA is a mandate contract, i.e., the Customer mandates the Genome Center to conduct service for them, and the Genome Center has its terms and conditions for that. Thus, the main text of the CSA is generic and applies to all projects unless your institution has established a strategic partnership agreement with the Genome Center.
Contrary to the generic main text, the Appendices are the part of the CSA where all details specific to a particular project are collected, and exact conditions agreed between the Customer and the Genome Center should be accurately recorded before signing.
Is the CSA available online?
Yes, a template of the up-to-date version of the CSA can be found at [WEBLINK].
Please note that the template is only for your information and cannot be used for signing. For signing, you will receive an email from the Genome Center that provides a link to the CSA in AdobeSign format for your review and signature.
Why do I need to complete a webform for Customer information?
The webform (Appendix 2 of the CSA) includes essential information about the project governance, processed samples, and details for administrative processes. The form needs to be completed by the Customer before signing the CSA.
By filling in the form, the Customer confirms that they have the authority and applicable approvals and/or consent to process provided samples and the right to transfer the samples to the Genome Center. In the webform, the Customer also authorizes additional persons whom the Genome Center can contact regarding the project, such as granting data access or forwarding documents for invoicing.
Additionally, ISO 15189 accreditation requires basic information about the submitted samples for tracking and improving the quality of the service.
What is included in the Genome Center standard services?
The Genome Center standard services include the following:
- Confirming the acceptance criteria to qualify for ISO 15189 clinical-grade sequencing are met for each sample (this applies only to those projects requiring accredited sequencing);
- Controlling the quality of the nucleic acids provided by the Customer (applies if necessary);
- Sample processing for both clinical-grade and non-clinical-grade sequencing and production of raw data (undemultiplexed reads);
- Analysing raw sequenced data and producing unaligned demultiplexed sequence data in the format of FASTQ files);
- Delivering FASTQ files and quality control reports to the Customer;
- Storage of the data in the Genome Center secure infrastructure for six calendar months as of the closure date of the project (timestamped on the delivery report).
For details, please see CSA Articles 1.2 and 3.
In what formats can I receive my data?
For each processed sample, the Genome Center standard delivery contains a FASTQ file and a delivery report with corresponding quality metrics.
BAM/SAM, VCF and JSON formats can be delivered upon agreement and are subject to an additional fee. Delivery of any additional information or data formats (e.g., merged FASTQ files) need to be discussed, priced, and agreed to as a non-standard service between the Customer and the Genome Center before signing the CSA.
What is the difference between data processing, analysis, and interpretation?
Data processing includes processing raw sequence data and producing unaligned demultiplexed sequence data, where the output format is FASTQ files.
Data analysis includes analysis of sequence data by the Genome Center standard pipelines, using a given set of references and standard parameters.
Data interpretation includes sequence data analyses according to custom parameters and all descriptive or non-conventional downstream data interpretation.
What are the responsibilities of the Genome Center?
The Genome Center is responsible for:
- Respecting the Swiss and international laws and the best practices governing and processing confidential data to protect the autonomy, privacy, and rights of the individuals whose samples will be sequenced;
- Providing to the Customer detailed information about the primary sample requirement metrics and the services;
- Securing integrity and security of the data, for protecting data against loss, unauthorized access, transmission, and abuse of access rights in the Genome Center secure infrastructure during the period when the CSA is in effect;
- In case of a data breach that affects the sensitive data of the Project, informing the Customer within 36 hours after having learned about the potential occurrence of data breach;
- Providing an estimated service delivery time according to the indicative timeline defined by the Customer and by the Genome Center in Appendix 1 of the CSA.
For details, please see the CSA Article 4 and the Genome Center website https://www.health2030genome.ch/accredited-sequencing-services
What are the responsibilities of the Customer?
The Customer is responsible for:
- Confirming in the webform (Appendix 2 of the CSA) that it has the authority to process provided samples and that it has the right to transfer the samples to the Genome Center;
- Confirming that a relevant institutional ethics review board or ethics commission has approved high-throughput nucleic acid sequencing of the provided samples (if applicable);
- Confirming that the collection, storage, and use of the provided samples is based on the free and informed consent of the subjects;
- Possessing the competencies and, if applicable, necessary certifications to process the biological samples according to the best laboratory practice protocols and to ensure accountable and lawful use of the obtained sequence data;
- Pseudonymizing all sample names before sending them to the Genome Center and not revealing to the Genome Center any identifying personal information of the individuals from whom the samples are derived;
- Following all precautions and instructions for sample quality, transportation of samples, and needs for special handling as described on the Genome Center website;
- Communicating with the subjects if they request information about the processing of their samples or personal data associated with it.
For details, please see the CSA Article 5 and the Genome Center website https://www.health2030genome.ch/accredited-sequencing-services
What are the role and the rights of the Genome Center regarding my data?
The Customer is the owner and the controller of the provided biological samples and the produced data. The Genome Center declares no ownership of the data or the intellectual property created using the data generated under this Agreement. The Genome Center only processes the samples and the data according to the mandate it receives from the Customer.
Can the Genome Center use or share my data?
The Genome Center CANNOT use or share Customer data with a third party.
In all cases, the Customer is and remains the data owner and controller. The Genome Center only processes the samples and the data according to the mandate it receives from the Customer. The Genome Center will not analyze, publish, share, or otherwise use any data that is generated or hosted in our environment unless a specific task is mandated to it by the data owner.
How do I know that my data are ready for delivery?
The Genome Center will inform the person designated for data downloading in the webform that the data are available on the secured FTP server.
How will the data be delivered?
The Genome Center standard practice for data delivery is via sFTP server and by providing authorized remote secured access to the individuals designated by the Customer in the webform for Appendix 2 of the CSA. Other methods can be discussed, as long as these are compliant with the Swiss Personalized Health Network (SPHN) Information Security Policy (SPHN_ISP.pdf).
Can the data be encrypted?
Yes, the Genome Center can encrypt the data before delivery. The price for this service is 20 CHF/sample. A complete price list of the Genome Center data governance services can be found [WEBLINK]
How can I authorize additional people to access my data?
The Customer designates in the webform (Appendix 2 of the CSA) the individuals to whom the data shall be transferred. If the Customer wishes to change the persons designated to access the data or authorize additional people, an official request must be sent to firstname.lastname@example.org. You need to provide the person’s name, email, and mobile phone number for creating an additional data access account.
Please note that the Genome Center standard service includes a one-time data delivery. Once the data is delivered, access to additional authorized persons can be organized upon the Customer’s request for an associated fee.
What happens after I have downloaded my data?
After downloading the files, checking their integrity, and letting the Genome Center DAIP know about successful transfer, the data will be removed from the sFTP server.
A copy of your data will remain at the Genome Center for 6 months. During this period, the Genome Center communicates with the Customer to confirm that they have verified the integrity of transferred data and secured necessary backups.
If you have any problems or questions regarding your data, please contact email@example.com
How long will the data be stored in the GC?
The data will be stored in the Genome Center secure infrastructure for six calendar months as of the closure date of the project. The closure date is indicated as a timestamp on the delivery report.
What if I don’t respond to the emails requesting approval to remove my data after 6 months?
The Genome Center does not remove any data without approval from the data owner.
When the six-month period is approaching its end, we will remind the Customer that their approval is needed. In case of no response or clear approval from the Customer by the end of sixth month after the closure date of the project, the Genome Center will automatically activate the data storage service for additional six months with a price of 20 CHF/TB/month.
Can the data be stored longer than 6 months?
Yes, the Genome Center provides to the customers an option to store their data in a secure environment beyond the standard service time of 6 months. The baseline price for data storage is 210 CHF/TB/year. The maximum duration of the storage service is 5 years, with an annual 15% decrease in base storage price.
Please note that the baseline price covers one-off data processing and delivery (timestamped at the end of the project). An additional fee applies to re-activation of the project, additional data access, etc. A complete price list of the Genome Center data governance services can be found [WEBLINK]
What if there is a data breach?
In the unlikely event of a data breach that affects project data, the Genome Center is responsible for informing the Customer within 36 hours after learning about the potential data breach. The Customer and the Genome Center then agree on how they will manage the event and who will be responsible for notifying the competent authorities and, if required, the concerned data subjects. These actions will be carried out according to the Swiss Federal Act on Data Protection (FADP).
How long will the signed CSA remain in effect?
The CSA remains in effect either for a fixed period of months determined in Article 8.2 of the CSA or until execution of the service and payment of invoices, as agreed and defined in Appendix 1.
What if I need to terminate the project before the service has been completed?
In case of termination of the project, before the service has been completed, the Customer and the Genome Center have no further obligations to each other under the Agreement, except for the payment of expenses for the work performed for the services up to the date of termination, as well as any reasonable expenses spent before the receipt of the termination notice.
Upon receiving a termination notice from the Customer, the Genome Center will terminate the service and deliver all written reports and invoices and provide all samples to the Customer.
Please see CSA Article 9.2 for more details.
What will happen to unused aliquots of DNA, RNA, and sequencing libraries submitted to the Genome Center for sequencing?
After the end of the project, the Genome Center does not store any samples provided by the Customer. Unused aliquots will be returned to the Customer at their expense or will be destroyed irreversibly.
What if I have additional questions regarding the Genome Center services and/or the CSA?
If you could not find an answer to your question here, please contact CSAfirstname.lastname@example.org
It is the responsibility of the Customer to ensure that they have consulted the most up-to-date version of the CSA and Customer FAQ at the Genome Center website.