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September 13, 2020

False Positives with BD Veritor. Several SNF members reported receiving false positive results for COVID-19 tests using the BD Veritor point-of-care (POC) machine. They confirmed these individuals truly were negative with polymerase chain reaction (PCR) tests. We understand some LeadingAge Ohio members also had this experience. False positives are a significant concern because they must be treated as true positives - with attendant disruption to the staff member or resident - until confirmed negative. Please report to OHCA any false positives with the BD unit (or the Quidel Sofia device, although we have not heard of any with that). This is a national issue, as AHCA's Dr. David Gifford provided the following advice for members who find false positives - please note in particular the bullet about not cohorting a patient with an unconfirmed positive POC test with confirmed COVID-19-positive patients:

  • BD has set up special direct number for providers to call ONLY about false positives
    • Call Sara Lewis at 207-522-7563 only for providers who experience multiple false positives (note: This number will likely be changed in the next few days).; or
    • email BD at
    • BD offers this microsite and these training webinars which we encourage members to review if they are having concerns with accuracy to make sure they are following all the instructions correctly. 
  • Members should in addition should notify their state public health agency.
  • Members should continue to use these POC tests but we encourage members to follow the CDC guidance and algorithm on when to conduct confirmation testing of positive antigen tests. We also would encourage members to conduct confirmation testing with PCR test in other situations not covered by CDC guidance where asymptomatic residents or staff test positive with the antigen tests given the recent reports of false positives. 
  • If asymptomatic residents test positive with an POC antigen test, they should be placed into TBC and single room if possible but not moved to a COVID-19 (+) or cohorted with a known positive resident until confirmation testing with PCR is obtained.

DOL Adopts Revised FFRCA Leave Rule. The Department of Labor (DOL) published a temporary rule on eligibility for paid family, medical, and sick leave under the Families First Coronavirus Response Act (FFCRA). Among other things, the new rule narrows the definition of health care providers who are exempt from the paid leave provisions, in response to a federal district court decision that struck down DOL's previous definition as exceeding the agency's statutory authority.

The new rule, which takes effect when it is published in the Federal Register (predicted to be September 16) and continues through the end of 2020, focuses on employees instead of employers, as was the case in the previous rule. The new rule includes employees who directly provide health care and those whose services "are integrated with and necessary to the provision of patient care and, if not provided, would adversely impact patient care." This unfortunately does not include ancillary employees such as, "IT professionals, building maintenance staff, human resources personnel, cooks, food services workers, records managers, consultants, and billers." We believe the definition of exempt employees can be read to include direct support professionals working in ICFs/IID and waiver settings.

The rule lists various facilities and businesses that could employ health care providers, but also notes that the list is not exhaustive. The illustrative examples include a "nursing facility, retirement facility, nursing home, home health care provider, any facility that performs laboratory or medical testing, pharmacy, or any similar permanent or temporary institution, facility, location, or site where medical services are provided." The revised rule does not retain the language from the previous version that allowed the chief executive of a state to designate other businesses as health care providers, as the revised rule bases the exemption on the employee, not the employer. 

Coronavirus Relief Fund Update. Budget and Management Director Kim Murnieks, Medicaid Deputy Director Patrick Beatty, and members of their staff provided a snapshot of state Coronavirus Relief Fund payments. The state has made four weekly payments totaling $220 million, less than half of the $471 million appropriated. Only 3,080 of 10,619 qualifying providers have applied (these figures include providers who qualify in more than one category). Director Murnieks expressed concern about getting the word to providers who have not applied, as the state must return any unspent money to the federal government at the end of the year. Here are the number of applicants by provider category:

  • SNF 915
  • Assisted living 573
  • ICF/IID 410
  • Home health 269
  • MyCare Ohio Waiver 158
  • PASSPORT 256
  • Ohio Home Care Waiver 133
  • Behavioral health 313
  • Hospital 53
The agencies continue to work through the lengthy list of providers whose applications matched the state's table on Medicaid number but not on one or more of the other fields the state uses. After that, they will turn to applicants whose Medicaid numbers did not match. Anyone who applied, received a confirmation email, and has not received payment still is going through the verification process. Anyone who inquires about their application status to should give their Medicaid number, National Provider Identifier (NPI), facility/agency address, corporate address, corporate name, and doing-business-as name.

OHCA Quick Videos Answer Frequently-Asked Questions. As another way of communicating key information to members who have little time to absorb all of what is flying around, we began to develop a series of brief videos that address issues about which members frequently ask. The first two videos address outbreak testing (for SNFs, but reflecting Centers for Disease Control and Prevention (CDC) guidance that applies to everyone) and use and fit testing of N95 and KN95 respirators (appropriate for all providers using respirators). More to come!

Interpreting Federal Testing Guidance for SNFs: Outbreak Testing. Centers for Medicare and Medicaid Services (CMS) Quality, Safety, and Oversight (QSO) letter 20-38-NH establishes various circumstances under which SNF staff and residents must be given COVID-19 tests. One such situation is an outbreak, which CMS, following in the footsteps of CDC, defines as a single new case among either staff or residents of a SNF. In the event of an outbreak, the guidelines require testing all residents and staff:

Upon identification of a single new case of COVID-19 infection in any staff or residents, all staff and residents should be tested, and all staff and residents that tested negative should be retested every 3 days to 7 days until testing identifies no new cases of COVID-19 infection among staff or residents for a period of at least 14 days since the most recent positive result.

While this language does not give a timeframe for the initial outbreak testing, we read it as requiring it immediately or as soon as possible. The wording "upon identification" suggests initial testing should begin when the positive test result becomes known. The QSO refers to CDC's "Testing Guidelines for Nursing Homes," which assert that, "[p]erforming viral testing of all residents as soon as there is a new confirmed case in the facility will identify infected residents quickly, in order to assist in their clinical management and allow rapid implementation of IPC interventions (e.g., isolation, cohorting, use of personal protective equipment) to prevent SARS-CoV-2 transmission." (Emphasis added.) This language, together with "upon identification" in the QSO, suggests that testing must begin right away.

Interpreting Federal Testing Guidance for SNFs: "48-Hour Rule." A number of members ask about laboratory turn-around time (TAT), particularly for the state-mandated testing, and express concern about violating the "48-hour rule," believing that QSO 20-38 requires SNFs to have 48-hour TAT. A corollary question is when the 48 hours start. The QSO does not require SNFs to achieve 48-hour TAT. There is no specific TAT required at all, although obviously longer time reduces or eliminates the value of the testing results in preventing viral spread. Instead, the QSO uses the 48-hour standard for the exemption from prescribed testing frequency for SNFs in red and yellow counties. A footnote to the testing frequency chart states: "[t]his frequency presumes availability of Point of Care testing on-site at the nursing home or where off-site testing turnaround time is <48 hours." The QSO goes on to specify:

If the 48-hour turn-around time cannot be met due to community testing supply shortages, limited access or inability of laboratories to process tests within 48 hours, the facility should have documentation of its efforts to obtain quick turnaround test results with the identified laboratory or laboratories and contact with the local and state health departments.

In the QSO's list of documentation required of SNFs, they elaborate on this statement with examples: "[w]hen necessary, such as in emergencies due to testing supply shortages, document that the facility contacted state and local health departments to assist in testing efforts, such as obtaining testing supplies or processing test results."