Summary:
Summary Statement of Deficiencies D0000 T he laboratorio Clnico Jolly Mar 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 February 4, 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 test report records review and testing personnel interview on February 4, 2021 at 1:00 PM, it was determined that the laboratory failed to report the SARS-Co- VIRAL RNA test results as required for 2 out of 10 days reviewed from January 5, 2021 to February 2, 2021. The findings include: 1. The laboratory utilized the Health Department written instruction to reports the SARS-Co-VIRAL RNA by the Bioportal. 2. The laboratory processed the SARS-Co-VIRAL RNA tests by the ID Now system. 3. The test report records showed that 2 out of 10 days from January 5, 2021 to February 2, 2021, the laboratory did not report the SARS-Co-VIRAL RNA negative results in the required frequency (24 hrs) by the Bioportal: Date Patients Date tested specimens reported 01/29/2021 16 02/01/2021 01/30/2021 7 02/01/2021 4. The testing personnel confirmed on February 4, 2021 at 1:00 PM that those negative results of SARS-Co-VIRAL RNA tests were not reported in 24 hrs. 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 --