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 surveyor review of quality control records, patient testing records, and interview with the laboratory director the laboratory failed to perform quality control (QC) each day of patient testing on chlamydia/gonorrhea and group B strep testing from 5/8/2024 - 3/20/2025. 1. Review of chlamydia/gonorrhea and group B strep QC records from 5/8/2024 - 3/20/2025 revealed QC was performed monthly. 2. Review of chlamydia/gonorrhea and group B strep patient testing records from 5/8/2024 - 3/20 /2025 revealed 65 patients tested for chlamydia/gonorrhea and 9 patients tested for group B strep. 3. Interview with the laboratory director on 3/20/2025 at 2:33 PM, confirmed the laboratory did not perform QC each day of patient testing for chlamydia /gonorrhea and group B strep. 4. Interview with the laboratory director on 3/20/2025 at 2:33 PM, confirmed the laboratory did not have an Individualized Quality Control Plan (IQCP) in place for chlamydia/gonorrhea and group B strep. 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 --