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 consultant, on 1/23/2024 at 12:08 PM, the laboratory failed to perform quality control (QC) each day of patient testing for 107 out of 119 days of chlamydia/gonorrhea testing from 3/20/2023 - 1/23/2024. Findings are: 1. Review of QC records from 3/20/2023 - 1/23/2024 for chlamydia/gonorrhea revealed QC testing was performed on 4/5/2023, 4/28/2023, 5/1/2023, 6/14/2023, 7/12/2023, 7 /25/2023, 8/10/2023, 9/1/2023, 10/26/2023, 11/2/2023, 12/6/2023, and 1/11/2024. 2. Review of patient testing records for chlamydia/gonorrhea, from 3/20/2023 - 1/23 /2024, revealed 123 patients were tested for chlamydia/gonorrhea from 3/20/2023 - 1 /23/2024. 3. Interview with the technical consultants confirmed the laboratory did not perform quality control each day of patient testing for chlamydia/gonorrhea. 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 --