Washington



R20-114 – INFORMATION

September 10, 2020

Amended May 11, 2021

|TO: |RCS Regional Administrators |

| |RCS NH Field Managers |

| |RCS Management Team |

| |RCS NH Staff |

|FROM: |Mike Anbesse, Director |

| |Residential Care Services |

|SUBJECT: |QSO-20-37-CLIA, NH AND QSO-20-38-NH REGARDING RULE CHANGES TO REQUIRE COVID-19 TESTING AND GUIDANCE |

|Purpose: |To notify staff about rule changes from the Centers for Medicare and Medicaid Services (CMS) that require |

| |facilities to perform COVID-19 testing for staff and offer COVID-19 testing to residents. |

|Background: |To help nursing homes control the spread of COVID-19, in late July 2020, CMS began sending point-of-care COVID|

| |testing instruments to nursing homes. Building on the increased test capacity this created, CMS also announced|

| |they would require nursing homes to test staff under certain conditions. |

|What’s new, changed, or |This bulletin is amended to include information from QSO-20-38-NH, which was revised on April 27, 2021. |

|Clarified: |Updated information in the revised memo includes: |

| |Definitions of “fully vaccinated” and “unvaccinated.” |

| |Clarification of testing requirements for fully vaccinated and unvaccinated staff, including routine testing, |

| |and symptom or outbreak triggered testing. Local health jurisdictions may have additional testing |

| |requirements. |

| |Recommendations for testing after a COVID-19 exposure. |

| |The revised memo also announced that the Infection Control Pathway (CMS-20054) was updated to reflect the |

| |revised testing standards. |

| | |

| |With QSO-20-37-CLIA, NH, CMS announced they published an interim final rule, CMS-3401-IFC. The rule was |

| |published in the federal register on September 2, 2020. |

| |The rule established a new requirement at 42 CFR §483.80 that requires nursing homes to test facility |

| |residents and staff, including individuals providing services under arrangement and volunteers. The new rule |

| |will be cited under F886. |

| |The rule also updated CLIA (Clinical Laboratory Improvement Amendments) regulations to require reporting of |

| |COVID-19 tests. Nursing homes using point-of-care COVID-19 testing devices under a CLIA Certificate of Waiver|

| |are required to report test results under this CLIA regulation. This reporting requirement is additional to |

| |the requirement to report COVID-19 data to the National Health and Safety Network (NHSN). |

| | |

| |QSO-20-38-NH provides guidance on when and how nursing homes must complete the required COVID-19 testing. The |

| |QSO memo also provides guidance to surveyors on reviewing the testing program. |

| |CMS revised “COVID-19 Focused Survey for Nursing Homes.” The document now includes steps to review the new |

| |testing requirement, and review of F882 and F886. The document is attached to the QSO memo. |

| |Surveyors will review facility testing documentation and complete observations and interviews according to the|

| |guidance in QSO-20-38-NH. |

| |If a facility has a shortage of testing supplies, or cannot obtain test results within 48 hours, the surveyor |

| |should ask for documentation that the facility contacted the Washington State Department of Health (DOH) and |

| |the local health jurisdiction to request assistance with the testing. |

| |Surveyors should also inform DOH and the local health jurisdiction of the facility’s lack of testing |

| |resources. |

| |Surveyors will review the CLIA Certificate of Waiver if the facility has one. If the surveyor identifies |

| |concerns about CLIA regulations, such as performing tests not authorized by the waiver or not reporting test |

| |results, surveyors will report the concerns to the Complaint Resolution Unit (CRU). CRU will forward the |

| |concerns to the DOH laboratory program for further investigation. |

| |When reporting concerns, include the CLIA number, the name and address of the laboratory (facility), the |

| |number of days tests were not reported, if known, and the number of results not reported, if known. |

| |Please note that QSO-20-38 has a different email address for reporting CLIA concerns. Please report to the CRU|

| |instead. Washington State is one of two states responsible for oversight and regulation of laboratory programs|

| |in lieu of CLIA, so Washington State has a different reporting mechanism. |

|ACTION: |Staff will: |

| |Effective immediately, begin review of testing programs using the updated focused survey pathway. There is a |

| |three-week grace period for reporting requirements only that begins September 2, 2020. |

|Related |QSO-20-37-CLIA, NH |

|REFERENCES: |QSO-20-38-NH-REVISED |

| |CMS-3401-IFC |

|ATTACHMENTS: |Dear NH Administrator - ALTSA: NH #2020-064 |

|CONTACTS: |Lisa Herke, Nursing Home Policy Program Manager at (509) 209-3088 or lisa.herke@dshs.. |

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STATE OF WASHINGTON

DEPARTMENT OF SOCIAL AND HEALTH SERVICES

Aging and Long-Term Support Administration

PO Box 45600, Olympia, WA 98504-5600

RCS MANAGEMENT BULLETIN

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