Summary:
Summary Statement of Deficiencies 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) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of quality control records, patient testing records, and interview with the technical consultants, on 8/14/2024 at 12:15 PM, the laboratory failed to perform quality control (QC) on the MedTox system detection of drugs of abuse each day of patient testing for 24 out of 29 days of patient testing from 1/10 /2023 - 8/8/2024. Findings are: 1. Review of MedTox QC records from 1/30/2023 - 8 /8/2024 revealed QC was performed on 1/10/2023, 2/17/2023, 3/17/2023, 4/13/2023, 5 /11/2023, 6/9/2023, 7/7/2023, 8/7/2023, 9/7/2023, 10/9/2023, 11/9/2023, 12/9/2023, 1 /9/2024, 2/8/2024, 3/8/2024, 4/2/2024, 4/30/2024, 5/20/2024, 5/31/2024, 6/24/2024, 7 /8/2024, 8/7/2024. 2. Review of MedTox patient testing records revealed patient testing was performed on 29 days from 1/10/2023 - 8/8/2024. Dates include: 1/30 /2023, 2/26/2023, 3/18/2023, 4/2/2023, 4/17/2023, 4/20/2023, 4/28/2023, 5/26/2023, 6 /8/2023, 6/18/2023, 6/21/2023, 8/12/2023, 8/13/2023, 8/28/2023, 9/11/2023, 11/30 /2023, 1/3/2024, 1/21/2024, 1/30/2024, 4/2/2024, 4/30/2024, 5/23/2024, 6/15/2024, 6 /24/2024, 7/8/2024, 7/12/2024, 7/15/2024, 8/7/2024, 8/8/2024. 3. Interview with the technical consultants confirmed the laboratory did not perform QC on 24 out of 29 days of patient testing on the MedTox system detection of drugs of abuse. 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 --