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Step 6.1 – Develop the use of digital data and diagnostics connectivity
Many of the latest testing instruments offer the opportunity to use digital data. The implementation plan should consider software and hardware requirements, to take advantage of digital data. “Diagnostic connectivity” refers to the ability to connect diagnostic test devices that produce results in a digital format, in such a way as to transmit data reliably to a variety of users (68). Key features of the systems are the ability to monitor performance remotely, conduct QA and manage inventory. With remote monitoring, designated individuals can use any internet-enabled computer to access the software, providing an overview of the facilities, devices and commodities in the network. Software can track consumption and inventory to avoid stock-outs and expiring supplies. It can also identify commodity lots or specific instruments with poor performance or abnormal error rates for QA purposes, and provide a pre-emptive service to avoid instrument failure. This approach is a highly cost-effective way to ensure that a diagnostic device network functions properly; it is also useful for reporting and connecting with treatment sites.
Data, results and information updates can also be transmitted automatically to:
- clinicians and patients, allowing for faster patient follow-up;
- laboratory information management systems or electronic registers, reducing staff time and the chance of transcription errors, and greatly facilitating monitoring and evaluation processes; and
- the NTP, assisting with surveillance of disease trends or resistance patterns and rates, and enhancing the capacity of the NTP to generate the data needed for performance indicators of the End TB Strategy.
Step 6.2 – Develop procedures for data backup, security and confidentiality
With any electronic data system, there is a risk of losing testing data. A SOP for regularly backing up data (e.g. to an external drive) is essential, as is a SOP for data retrieval. Also needed are policies and procedures to ensure the security of laboratory data and confidentiality of patient data, in line with national and international regulations. Antivirus and antipiracy software should be installed and kept up to date. Antihacking mechanisms should be in place, as should access restriction to safeguard confidentiality, protect personal information and prevent data breaches by unauthorized users. Data access and governance policies should be developed and enforced.
Step 6.3 – Data requirements for targeted NGS
Data storage requirements, data analytical tools and data-sharing protocols needed for targeted NGS are more complex and require a comprehensive strategy, possibly with technical assistance from an IT expert or department. A checklist to assess IT and data readiness is included in the site readiness checklist in Annex 3 of the WHO implementation manual (33).