Summary:
Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on record review, policy review, and staff interview, the laboratory failed to perform a positive and negative control each day of patient testing for urine drug screens on the MedTox Scan analyzer for 2 of 3 patient testing days (02/04 and 02/18) in February 2025. The laboratory performed four urine drug screen patient tests on days with no quality control (QC) performance in February 2025. Findings include: 1. Reviewed on 03/25/25, the patient testing records for urine drug screens on the MedTox Scan analyzer indicated performance of patient testing on the following days in February 2025: 02/04, 02/18, and 02/24. 2. Reviewed on 03/25/25, the February 2025 QC records for urine drug screens failed to include evidence of the performance of positive and negative controls on the following patient testing days: 02/04 and 02 /18. 3. Reviewed on 03/25/25, the policy "Quality Control Policy," dated 02/2020, stated, ". . . 4. Miscellaneous Tests . . . A positive and negative test will be done each day of testing for the following tests: . . . MedTox Drug Screens . . ." 4. During interview at 1:25 p.m. on 03/25/25, a technical consultant (#1) confirmed the laboratory failed to perform QC each day of patient testing for urine drug screens on the MedTox Scan analyzer in February 2025. 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 --