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 personnel records, review of instructions for use (IFU), and interview with technical consultant (TC) 4/26/21, the laboratory director (LD) failed to follow manufacturer's instructions for the SARS-CoV-2 testing performed to ensure 5 of 5 TP had received appropriate training for the performance of SARS-CoV-2 testing and to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test result reports. The laboratory began testing for SARS-CoV-2 using the Quidel Sophia2 Flu and SARS test system and the Cepheid GeneXpert Xpress SARS-CoV-2 test system on 1/29/21. 1. The LD failed to ensure 5 of 5 TP received appropriate training for the performance of SARS-CoV-2 testing. Findings: Review of IFU for Quidel Sophia2 Flu and SARS test system revealed on page 14 "Conditions of Authorization for the Laboratory and Patient Care Settings...All operators using your product must be appropriately trained in performing and interpreting the results of your product...and use your product in accordance with the authorized labeling." Review of IFU for Cepheid GeneXpert Xpress SARS-CoV-2 revealed under section 21 "Conditions of Authorization for Laboratories...All operators using your product must be appropriately trained in performing and interpreting the results of your product...and use your product in accordance with the authorized labeling." Review of personnel records for TP #1, TP #2, TP #3, TP #4 and TP #5 revealed no documentation of training for the SARS-CoV- 2 testing performed. Interview with TC at approximately 11:50 a.m. confirmed the personnel records did not contain documentation of training. She stated that all TP were trained but she was unaware the training for SARS-CoV-2 testing needed to be documented. 2. The LD Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- failed to ensure authorized Fact Sheets for patients and providers were included with SARS-CoV-2 test result reports. Findings: Review of IFU for Quidel Sophia2 Flu and SARS test system revealed on page 14 "Conditions of Authorization for the Laboratory and Patient Care Settings...Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets." Review of IFU for Cepheid GeneXpert Xpress SARS-CoV-2 revealed under section 21 "Conditions of Authorization for Laboratories...Authorized laboratories using your product must include with test result reports all authorized Fact Sheets." Interview with TC at approximately 3:00 p.m. confirmed the laboratory does not provide the authorized Fact Sheets to patients and providers with the SARS-CoV-2 test result reports. She stated they distribute to patients information in regards to infection control for SARS- Cov-2 after they have been swabbed for testing, but no authorized Fact Sheets are provided to patients or providers with the test result reports. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of 2019, 2020 and 2021 American Proficiency Institute (API) proficiency testing (PT) records and interview with technical consultant (TC) 4/26/21, the laboratory failed to ensure 2 of 5 testing personnel (TP) participated in 7 of 7 Hematology PT events for the performance of Complete Blood Count (CBC). Findings: Review of 2019, 2020 and 2021 API PT records revealed TP #4 and TP #5 had not participated in 7 of 7 Hematology PT events. Interview with TC at approximately 2:30 p.m. confirmed TP #4 and TP #5 had not participated in 7 of 7 Hematology PT events. She stated they occasionally perform CBC testing and she was not aware they should be participating in PT. 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 laboratory records, and interview with TC 4/26/21, the laboratory failed to verify the accuracy of the D-dimer testing from the time testing began, February 4, 2020, until January of 2021, a period of approximately 10 months in which patient testing was performed.. Findings: The laboratory began D-dimer testing on the Quidel Triage - Meter Pro analyzer February 4, 2020. Review of laboratory records revealed the laboratory verified the accuracy of the D-dimer testing in January of 2021 by participating in American Proficiency Institute (API) proficiency testing (PT) for D-dimer. There was no documentation the laboratory had verified the accuracy of the D-dimer testing prior to January of 2021. Interview with TC at approximately 3:45 pm confirmed the laboratory had not performed a verification of -- 2 of 8 -- accuracy for D-dimer testing from February 4, 2020 until January of 2021. She stated she did not realize the facility was not enrolled in PT for D-dimer but once realized she enrolled them in API to meet the performance verification requirements. 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)