Brookhaven Tn Opco Llc

CLIA Laboratory Citation Details

2
Total Citations
2
Total Deficiencyies
2
Unique D-Tags
CMS Certification Number 44D0907757
Address 2035 Stonebrook Place, Kingsport, TN, 37660
City Kingsport
State TN
Zip Code37660
Phone(423) 246-8934

Citation History (2 surveys)

Survey - March 23, 2021

Survey Type: Complaint

Survey Event ID: OQIX11

Deficiency Tags: D1001

Summary:

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: =================================== Based on review of the manufacturers package insert for BinaxNOW COVID-19 Ag Card test and interviews with the Director of Nursing and Risk Manager determined that the laboratory failed to follow manufacture package insert for specimen collection for COVID-19 Ag Card test. The findings include: 1. Review of the manufacturers package insert for BianaxNOW COVID-19 Ag Card test states to use "nasal swab specimens." 2. Interviews with the Director of Nursing and Risk Manager on March 17, 2021 at 10: 00 am confirmed that the laboratory failed to follow manufacturers package insert instructions for collecting nasal swab specimens. Director of Nursing and Risk Manager stated, "nasopharyngeal swab specimens" were used for BianaxNOW COVID-19 Ag Card testing. =================================== 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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Survey - March 22, 2021

Survey Type: Special

Survey Event ID: KBU311

Deficiency Tags: 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 of testing documentation and result reporting spreadsheets via email and interviews with the Director of Nursing and Risk Manager, the laboratory failed to report SARS-Co-V-2 test results as required for 15 of 54 days reviewed from January 2021 through March 2021. The findings include: 1. SARS-Co-V-2 testing date documentation was reviewed via email from January 22, 2021 through March 16, 2021. 2. SARS-Co-V-2 test result reporting documentation spreadsheets were reviewed from January 22, 2021 through March 16, 2021. 3. Documentation revealed that SARS-Co-V-2 test results were not reported as required for 3 days in January 2021, 8 days in February 2021 and 4 days in March 2021. 4. Interview with the Director of Nursing and Risk Manager on March 17, 2021 at 12:30pm and documentation reviewed revealed the laboratory failed to report SARS-Co-V-2 test results as required for 15 of 54 days from January 2021 through March 2021. This COVID survey was conducted in conjunction with complaint # TN00053367. 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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