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 manufacturer's instructions, review of personnel records, and interview with the GS (general supervisor) 1/7/21, the laboratory failed to follow manufacturer's instructions for performing the FaStep COVID-19 IgG/IgM Rapid Test Device. Findings: 1. The FaStep COVID-19 IgG/IgM Rapid Test Device manufacturer's product insert states on page 2 "LIMITATIONS OF THE TEST 1. Use of the Fastep COVID-19 IgG/IgM Rapid Test Device is limited to laboratory personnel who have been trained. ..." The FaStep COVID-19 IgG/IgM Rapid Test Device manufacturer's product insert states on page 2 "Conditions of Authorization for the Laboratory ... 6. All laboratory personnel using your product must be appropriately trained in immunoassay techniques and use appropriate laboratory and personal protective equipment when handling this kit and use your product in accordance with the authorized labeling. All laboratory personnel using the assay must also be trained in and be familiar with the interpretation of results of the product. ..." Review of personnel records revealed there were no training records available for 2 of 2 testing personnel (the technical supervisor and testing personnel #1) for the FaStep COVID-19 IgG/IgM Rapid Test Device. During interview at approximately 12: 10 p.m., the GS confirmed that the laboratory did not have any documented training for the FaStep COVID-19 antibody test. 2. The FaStep COVID-19 IgG/IgM Rapid Test Device manufacturer's product insert states on page 2 "Conditions of Authorization for the Laboratory ... 1. Authorized laboratories using your product will include the test test result reports, all authorized Fact Sheets. ..." During interview at approximately 1:15 p.m. the GS verified that the laboratory did not include Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- appropriate Fact Sheets (Fact Sheet for Healthcare Providers or Fact Sheet for Recipients) with patient test reports. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, the absence of records, and interview with the GS (general supervisor) 1/7/21, the laboratory failed to either enroll in proficiency testing or establish a system to verify the accuracy of its COVID- 19 PCR (polymerase chain reaction) testing at least twice a year. Review of the laboratory's policies and procedures revealed the laboratory did not have a proficiency testing procedure or a policy describing their process for verifying the accuracy of the COVID-19 PCR testing at least twice a year. There were no proficiency testing records available for review at the time of the survey. There were also no accuracy verification records available to indicate that the laboratory had a system in place to verify the accuracy of the COVID-19 PCR testing at least twice a year. During interview at approximately 10:10 a.m., the GS stated that they performed a split- sample comparison with another laboratory as part of their validation, but he verified that the laboratory was not enrolled in proficiency testing and had not established a system to verify the accuracy of the COVID-19 PCR testing at least twice a year. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)