NAHLN SCOPE DISEASES: MAINTAIN CAPACITY FOR OUTBREAK RESPONSE

<b>Project Methods</b><br> Primary Data GenerationPrimary data generated for this grant will be both non-digital (sample submission forms, testing processing, interpretation for immunohistochemistry slides) as well as digital generation by equipment from laboratory work (real-time PCR results, ELISA testing results, bacterial isolates and MIC profile and whole genome sequence of bacterial isolates for AMR project). Both types of data will be stored and maintained as records as well as the final test results entered into LIMS. All diagnostic testing for this cooperative agreement are part of specific NAHLN testing protocols for procedures, equipment, and consumables.Data format and transmission to NAHLNRaw data generation from equipment and testing procedures (PCR, ELISA) are in a standardized format and will be converted to standard final test results (e.g. Detected, Not Detected) that is stored in WVDL LIMS and shared via HL7 e-messaging to the Laboratory Messaging System (LMS) or other VS systems. This will apply to all laboratory approved NAHLN assays. Data in LIMS is stored either within the database or on application/file servers. Bacterial identification and AMR isolates data and bacterial whole genome sequencing raw and processed data generation are also in a standard format and will be stored in WVDL file servers. AMR isolates will be share via monthly Excel spreadsheet submission to the AMR project, while the WGS data will be shared via cloud based site such as the USDA CloudVault site.Data storage and preservationData generation in this grant falls under WVDL Records Retention and Disposition Schedule, which is that data will be retained for at least 10 years. During the retention period, records willbe stored in a manner that they are readily retrievable and integrity preserved. Some hardcopy records will be stored in file cabinets located in access-controlled rooms. While electronic records will be stored in permission-restricted file servers on the WVDL network, or WVDL file servers within a permission-restricted folder. The servers are routinely backed up to disk and or tape and is recoverable in the event of data loss or disaster. Some records produced by instrument computers/software will be transferred from the local computer to a designated WVDL file server. Transfer/back up will occur according to the frequency defined in the related equipment record.Data sharing, protection, and public accessDiagnostic test results for NAHLN scope diseases will consistently be electronically messaged, using HL7 standards, to the Laboratory Messaging System (LMS) or other VS systems for all laboratory approved NAHLN assays. Assembled and non-assembled whole genome sequencing data will be shared through the USDA CloudVault site, the default site for data depository. Client confidentiality, personal privacy, business confidential information will be protected according to WVDL client confidentiality policy, in compliance to AAVLD standard. However, records of the WVDL are subject to the Wisconsin Open Records Law (Wi. Statute 19.31-39) and are available on written request by use of the Third-party Information Request Form or may be requested directly through UW-Madison Public Records Portal.Roles and responsibilitiesIt is the responsibility of all WVDL personnel to manage records of all work or operations performed in the format prescribed by the WVDL Quality System. The section head or supervisor of each section is custodian of technical records and includes client analysis requests, original analysis observations, manual calculation checks, derived data, equipment activity records and sufficient information to establish an audit trail including any written original observations or data related to a submission or testing activity. The Director of IT is the custodian of information technology related records. The Quality Manager is the custodian of quality system records including internal and external audits, corrective and preventative action requests, lab-wide quality related training records, and management reviews. The project director (PD) and co-PDs will follow the WVDL Quality System and policies to manage and disseminate data generated by this project.