The SARS-CoV-2 virus has wreaked havoc across the world, with the elderly population being particularly vulnerable to suffering severe consequences from the disease. As of October, globally confirmed cases were more than 45 million with nearly 9 million in the United States. Deaths across the globe reached higher than 1.18 million with more than 228,000 in the U.S.
The high prevalence and disparity of symptoms and disease prognosis has complicated tracking and mitigation of virus spread. Laboratory testing difficulties, including shortages of reagents, collection materials, and personal protective equipment, have stymied testing efforts. As cases have rapidly increased, the need for rapid turnaround time (TAT) has been realized, opening the door for diagnostic point-of-care testing (POCT) to be included as part of an overall testing strategy.
While it is recognized that POCT often comes with a lesser sensitivity and specificity, the trade-off for rapid TAT is worthwhile in certain patient scenarios. In particular, testing a vulnerable population for a deadly virus fits the criteria.
With more than 260,000 COVID-19 cases and greater than 60,000 deaths among nursing home residents as of early October, the elderly population, particularly in this healthcare environment have been recognized as a vulnerable population that can benefit from rapid POCT. To address this need, the Department of Health & Human Services (HHS) has taken several actions to reduce testing TAT, including distribution of POCT devices to skilled nursing facilities, prioritizing those in COVID-19 hot spots or those who do not have access to other testing. The CDC is recommending baseline testing of all residents and staff and regular screening and surveillance to detect potential outbreak situations early and reduce morbidity and mortality.
HHS is in the process of distributing POCT devices with a goal of sending help to 14,000 facilities that hold a CLIA Certification of Waiver (CoW). While the devices are initially free of charge, facilities will have to purchase subsequent supplies. Nursing homes that did not have a CLIA CoW by September 30th were not eligible to receive the testing platforms from HHS. However, nursing homes that gain CLIA certification will be prioritized for POCT devices when they order from the manufacturer or distributor.
The POCT devices that are being distributed to nursing homes are the Quidel Sofia and the BD Veritor Plus, both CLIA-waived with an approximately 15-minute TAT. The CDC has also provided criteria to nursing homes for reflex testing to confirm positives when indicated. Results need to be confirmed via reflex to a molecular testing methodology when an asymptomatic individual tests positive at a facility that does not have an outbreak.
Coronavirus Aid, Relief, and Economic Security (CARES) Act
In addition, the CARES Act requires any laboratory that is performing diagnostic COVID-19 testing to report test results to HHS and state or local public health departments using existing reporting channels. The regulation requires laboratories to report 23 specific data elements (e.g., test ordered, LOINC codes, device identifier, test result, test result date, specimen ID, patient age, etc.) to state or local public health departments, who will in turn provide this data to HHS.
Orchard’s Point-of-Care COVID-19 Integration Solution
Orchard has laboratory solutions to support skilled nursing facilities in their fight to slow the spread of COVID-19. Orchard is implementing its POCT management and integration solution as a SaaS model that is administrated by Orchard. The solution provides POCT device, EMR, and reference lab integration, as well as interfacing to HHS, State Health Departments, and the CDC. Orchard® Point-of-Care™ can provide the much-needed connectivity to automate transmission of orders and results, provide ask on order entry questions to meet HHS mandates, and automate reflex test ordering and routing for asymptomatic negative patients. Orchard’s solution equips nursing homes with tools that help compile and report the required data according to HHS Lab Data Reporting Guidance for COVID-19. In addition, implementing an automated and rules-driven workflow can yield a significant ROI by reducing errors and saving valuable FTE time.
For more information, contact your Orchard Account Manager at (800) 856-1948.