As some countries begin to ease social distancing restrictions and many more consider such moves, the WHO is urging caution on the basis of current knowledge that COVID-19 accelerates quickly but appears to decelerate much more slowly. Whatever decisions national governments take regarding a return to more normal activity, there is a general consensus that we will have to live with this coronavirus for many months, and perhaps years, to come. Guidance from national health authorities, such as the US CDC, has brought home to employers the importance of ongoing health monitoring of core workforces in order to ensure continuity of operations. Such an undertaking should be evidence-based and be resource-efficient in terms of evidence generation, aggregation and analysis.
The end-goal of any Regen Med Project is not to consult; it is to provide a turnkey, evidence-based solution. In this case, we work with our Client to generate relevant and timely evidence from ongoing COVID-related health monitoring of the Client’s employees. The objective is to avoid disruption of operations due to the spread of the virus within the workforce.
Achieving this result requires, as the initial step, a focused interaction with one or more representatives of the Client to coordinate with Regen Med on the Project Design and its implementation. This Working Group will:
Select the employee groups to be included in the project and identify Corporate Coordinators and Team Members to involve and their various levels of data access permission.
- Review the privacy aspects and define the needs in terms of external data storage and management.
- Evaluate the appropriate level of integration with existing employee health and human resource policies in the framework of ongoing interactions with workforce representatives.
- Define Telehealth aspects including the profiles of healthcare professionals to involve.
- Determine the specific data points relevant to each set of evidence. These would include:
- Employee voluntary self-enrollment and consenting procedures.
- Pertinent COVID-19 symptoms to be monitored by employees and the frequency of monitoring, e.g. daily diary.
- Contact tracing surveys to be compiled in the event than an employee shows COVID symptoms or has been exposed.
- Data package required to allow a health care professional to authorize return to work following self-isolation or illness.
- Employee education modules on how to reduce the spread of COVID-19.
- Develop the protocols implementing the foregoing datapoints. These protocols would be set-up within Regen Med’s inCytes platform.
- Define automatic Alert criteria.
- Develop the Client Report templates presenting the aggregated evidence generated.
- Develop employee Report templates.
- Delineate specific reaction modalities in the event of an employee presenting positivity for COVID-19 or having been exposed.
Timing and Implementation
Project Design Steps 1 – 5: Two to four working weeks.
Project Design Steps 6 – 9: Two to four working weeks. Some steps may be executed in parallel with prior steps.
Regen Med to provide all:
- Scientific and clinical expertise relating to the evidence generation projects. (Regen Med can also work with Client’s domain experts as desired.)
- Engagement with employee representation, healthcare providers, healthcare professionals and other constituencies identified by Client. Examples of engagement includes initial explanation of nature and benefits of project, associated education and training and ongoing communications.
- Within Regen Med’s inCytes platform: coding, HIPAA/GDPR and other security, registry structure, automated communications, data correlation functions. Technical integration with existing systems.
- All tools for pre-, peri- and post-procedural evidence collection, aggregation and analysis.
- Project management, including operational, financial and other.
- KPI reports to all Client stakeholders.
- Establishment of, and/or integration with existing, communications channels, and the development of professional, Project-specific content for access through such channels.
It is the goal of Regen Med to show concrete results as soon as possible in addressing the specific issue underlying a given Project. The Project Design phase requires the active involvement of Client representatives, but the implementation phase can largely be undertaken by Regen Med.
Budget depends on the final Project Design. To a substantial extent, Regen Med prices its services to correspond to achievement of concrete KPI’s reflecting that design.