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 record review, staff interview, and policy/procedure review, the laboratory failed to perform a positive and negative control each day of patient testing for Helicobacter pylori (H. pylori) antigen tests for 8 of 9 patient testing days (04/11, 04 /24, 04/30, 06/21, 07/12, 07/25, 07/27, and 08/02) since the start of a new test method in April 2024. The laboratory performed eight H. pylori antigen tests on days with no quality control (QC) performance in April-August 2024. Findings include: 1. Reviewed on 09/10/24, the patient testing records for H. pylori antigen indicated performance of one patient test using the TechLab H. pylori Quik Chek test kit on the following days in April-August 2024: 04/11, 04/24, 04/30, 05/31, 06/21, 07/12, 07/25, 07/27, and 08/02. 2. Reviewed on 09/10/24, the April-August 2024 QC records for H. pylori antigen failed to include evidence of the performance of positive and negative controls on the following patient testing days: 04/11, 04/24, 04/30, 06/21, 07/12, 07 /25, 07/27, and 08/02. 3. During interview at 8:55 a.m. on 09/10/24, a technical supervisor (#1) confirmed the laboratory failed to perform QC each day of patient testing for H. pylori antigen since the lab started using a new test method in April 2024. 4. Reviewed on 09/10/24, the policy/procedure "H. pylori Antigen," dated 07 /2023, stated, ". . . Procedure: . . . Classified as moderately complex . . . Quality Control - . . . External Quality control - . . . a positive and negative external control is 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 -- performed when opening a new kit and monthly. . . ." The policy/procedure failed to require the performance of a positive and negative external control each day of patient testing. -- 2 of 2 --