Keys to managing point-of-care testing compliance
In an effort to combat the spread of the virus and to help nursing homes protect the health and safety of their residents, the U.S. Department of Health and Human Services is distributing SARS-CoV-2 antigen diagnostic tests to more than 14,000 facilities.
To be eligible, nursing homes must have a current CLIA Certificate of Waiver and meet certain epidemiological criteria. Each nursing home will receive one shipment that includes supplies to facilitate baseline testing and enable a pathway to conduct ongoing testing according to public health guidelines. Antigen testing equipment authorized by the Food and Drug Administration will be supplemented by test kits that do not rely on equipment.
The cost of the test is relatively inexpensive, but nursing homes are likely to consume the limited supply provided by HHS because of the twice-weekly testing in yellow and red zones. HHS has not made a firm commitment for addressing potential supply-chain issues, including price and availability, that may arise due to massive product demand.
Simultaneously, The Centers for Medicare & Medicaid is enacting regulations to enforce testing and reporting, potentially causing double-jeopardy for nursing homes that continue to struggle from staffing shortages and high turnover. Some states tried to block the use of antigen testing, but HHS noted that the more accurate lab-based tests have been plagued by delays and shortages. HHS argued antigen testing is the best option available.
On August 31, HHS released its guidance for PREP Act coverage for COVID-19 screening tests at nursing homes, which removed the states’ rights to limit antigen prescribing and testing for asymptomatic individuals. While this cleared the way to proceed with antigen testing, it did not clarify outstanding differences in guidance previously issued by the FDA, CDC and CMS.
According to HHS, point-of-care antigen devices were scheduled to reach most nursing homes by the end of October.
While complimentary manufacturer and CMS training will help facilities meet some of the requirements for CLIA Waived tests, concerns remain. Some of the equipment offers options for automated record keeping, but generally they require the operator to document results manually. Without a comprehensive plan, this may leave nursing homes at risk during an inspection or audit.
To effectively maneuver the new regulations, facility administrators should keep in mind four areas:
Policies and procedures
Some of the testing equipment has built-in procedural controls and automated quality control documentation, and one of them is administered through the use of a kit. Nursing homes should incorporate manufacturer’s instructions for use into their policies and procedures, as well as make package inserts and policy updates readily available for staff.
Good laboratory practices
The CDC suggests all types of CLIA Waived facilities follow Good Laboratory Practices to reduce risk of errors. GLPs include following the most current manufacturer’s and infection prevention processes. Operators should be very familiar with all of the requirements prior to conducting a test.
Training and competency
CLIA Waivers do not have requirements beyond following the manufacturer’s instructions on the product insert. It is important for facilities to have a mechanism that documents training and competency to ensure processes are followed and staff are capable of performing tests correctly.
According to CMS FAQs, each test takes about 20 minutes to perform from start to finish. It is possible to run tests in an assembly line fashion to complete 20-30 samples per hour. This could create significant challenges for those administering the test when they are also responsible for assisting with other daily activities. If reimbursement is involved, it would be highly advisable to use a system that can also stand the test of a CMS audit.
CMS required all states to complete inspections at all nursing homes, and positive tests must be reported within 24 hours. A contributing factor to the spread of COVID-19 is due to infection control and reporting failures, resulting in $15 million in civil monetary penalties levied by CMS. It is vitally important to document all COVID-19 compliance and reporting activities to avoid citations and fines.
Facilities that do not comply with the new requirements are likely to be cited and may face enforcement sanctions based on the severity of the issues found by CMS inspectors. Non-compliance is costly, with penalties in excess of $400 per day, or over $8,000 for each instance.
Nursing homes have the opportunity and responsibility to provide a safe environment for their residents and staff. To accomplish this, facility administrators should consider all resources available, including a more comprehensive compliance and learning management system. This will be helpful to an organization as it works to retain and build confidence, prevent outbreaks and manage those who unfortunately test positive.
Brian Williams, MHA, MBA, has more than 25 years of director-level healthcare management experience, specializing in staff management, process improvements, infection prevention, performance measurement metrics and healthcare compliance. He serves on the MedTrainer Education and Development Board.