Summary:
Summary Statement of Deficiencies D0000 The laboratorio Clnico Metro Pava Clinic Carolina was found to be in substantial compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited as a result of an onsite survey performed on July 14, 2021. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on Covid-19 report records review and general supervisor interview on June 14, 2021 at 1:40 PM, it was determined that the laboratory failed to report the Covid- 19 results as required for 8 out of 8 days reviewed from May 5, 2020 to to September 8, 2020. The findings include: 1. The laboratory utilized the Health Department instruction to send the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 rapid test by Orient Gene method ( from May 5, 2020 to to September 8, 2020) and Corona Check method ( from May 5, 2020 to July 22, 2020). 3. On on June 14, 2021 at 1:40 PM, the Covid-19 report records showed that the laboratory did not send the Covid-19 results in the required frequency (24 hrs) to the Bioportal in 8 out of 8 days reviewed from May 5, 2020 to to September 8, 2020. Date Patients Date tested specimens reports ID sent 05/05/2020 184744 05/27/2020 05/14/2020 185180 05/20/2020 06/10/2020 186973 06/16/2020 06/18/2020 187665 06/27/2020 06/23 /2020 187977 06/27/2020 07/10/2020 18905 07/14/2020 08/18/2020 192799 08/25 /2020 09/04/2020 194199 09/09/2020 4. The general superviosr confirmed on on June 14, 2021 at 1:40 PM, that the records showed that the laboratory did not send those Covid-19 results in the required frequency (24 hrs) to the Bioportal. 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 --