Summary:
Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of testing records for the Healgen COVID-19 IgG/IgM Rapid Test Cassette, lack of documentation of verification of performance specifications, and interview with staff on 10/23/20 at 10:30 am, the laboratory failed to ensure that performance specifications were verified before reporting patient test results. ?The lab started using this antibody test on 8/14/20. Findings: 1. No documentation of verification of performance for the Healgen COVID-19 IgG/IgM Rapid Test Cassette was available for review on the day of survey. 2. Interview with laboratory staff on 10 /23/20 at 10:30 am revealed no verification of performance specifications was completed before testing patients. 3. Approximately 102 patients had been tested by the laboratory since the test was started on 8/14/20. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) and patient records for the Healgen COVID- 19 IgG/IgM Rapid Test Cassette from 8/14/20 through 10/20/20 and an interview with the laboratory general supervisor (GS) on 10/22/20 at 11:30 am, the laboratory failed to include a positive and negative control on each day of patient testing for antibodies to SARS-CoV-2. Findings Include: 1. Review of the QC and patient records for the Healgen COVID-19 IgG/IgM Rapid Test Cassette, performed from 8/14/20 through 10 /20/20, indicated that two levels of QC (positive and negative) were not performed on each day of patient testing. 2. Interview with the laboratory GS on 10/22/20 at 11:30 am confirmed that laboratory testing personnel were not performing two levels of QC on each day of patient testing with the Healgen COVID-19 IgG/IgM Rapid Test Cassette. QC had been performed per shipment or lot number. 3. Review of the patient COVID-19 Antibody test log from 8/14/20 through 10/20/20 revealed a total of 102 patient specimens were tested and reported with no documentation of the performance of 2 levels of controls each day of testing. 4. According to the QC and patient test log, QC had been performed only twice--on 8/14/20 (lot number 2006139) and again on 10/20/20 (lot number 2006139). -- 2 of 2 --