Summary:
Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, quality control (QC) testing records, lack of individualized quality control plan (IQCP) and interview with the laboratory technical supervisor on December 15, 2021 at 3:40 pm, the laboratory failed to perform QC at least once each day patient specimens were assayed for the Avagen test in 2020 and 2021. The findings include: 1. The laboratory failed to run QC each day of patient testing or to establish an IQCP as specified in Appendix C of the State Operations Manual (CMS Pub. 7) when QC was not run each day of patient testing for the Avagen test. Hence, the accuracy of the reported patients' results could not be assured, and thus potentially harmed patients. 2. On December 15, 2021 at 3:40 pm, laboratory Technical Supervisor affirmed that the laboratory did not establish an IQCP or run QC everyday of patient testing for the Avagen test. 3. The laboratory's testing declaration form, signed by the laboratory Director on December 13, 2021, stated that the laboratory performs 2,000 tests annually. D5485 CONTROL PROCEDURES CFR(s): 493.1256(h) 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 -- If control materials are not available, the laboratory must have an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be documented. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, quality control (QC) testing records, lack of individualized quality control plan (IQCP) and interview with the laboratory technical supervisor on December 15, 2021 at 3:40 pm, the laboratory failed to have a system in place to detect immediate errors and monitor Avagen test system performance over time. The findings include: 1. The laboratory developed an in-house test and named it as Avagen test. It used next-generation DNA sequencing technique to detect nucleic acids in the patients' swab samples and reported a risk factor. The technical supervisor said that there was no QC material available for this test. In this scenario, laboratories may choose to split samples for testing by another method or in another laboratory to evaluate the results obtained. Previously tested patient specimens (include specimens across the reportable range) could be tested in duplicate. Precision is determined through replicate testing of a previously tested patient specimen. The results compared to previously defined acceptable limits for differences between duplicates. However, the laboratory did not have an alternative mechanism to detect immediate errors and monitor test system performance over time for the Avagen test. Hence, the accuracy of the reported patients' results could not be assured, and thus potentially harmed patients. 2. On December 15, 2021 at 3:40 pm, laboratory Technical Supervisor affirmed that the laboratory did not have a system to monitor the Avagen test performance over time. 3. The laboratory's testing declaration form, signed by the laboratory Director on December 13, 2021, stated that the laboratory performs 2,000 tests annually. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, quality control (QC) testing records, lack of individualized quality control plan (IQCP) and interview with the laboratory technical supervisor on December 15, 2021 at 3:40 pm, the laboratory director failed to ensure the quality of the Avagen test by not having a control to detect immediate errors and monitor test system performance over time. The findings include: See D5445 and D5485. -- 2 of 2 --