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CLIA Laboratory Citation Details

1
Total Citation
2
Total Deficiencyies
1
Unique D-Tag
CMS Certification Number 23D2192497
Address 2539 Ellsworth, Ypsilanti, MI, 48197
City Ypsilanti
State MI
Zip Code48197
Phone(734) 330-2800

Citation History (1 survey)

Survey - February 24, 2021

Survey Type: Special

Survey Event ID: QH7011

Deficiency Tags: D1002 D1002

Summary:

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to report SARS-Co-V-2 test results as required for 160 testing days from September 2020 through February 2021. Findings include: 1. A review of the laboratory's SARS-CoV-2 policy titled "COVID-19 Testing" revealed a section stating, "All on site rapid Covid-19 positive tests must be reported to the county." 2. An interview on 2/24/21 at 9:00 am with the Laboratory Director revealed the laboratory had been testing patients for 160 days since September 2020 and had not been reporting the negative results to the state or local health department. 3. The Laboratory Director confirmed the findings on 2/24/21 at 9:00 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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