North Little Rock Women's Clinic

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based upon a review of the American Proficiency Testing Institute (API) proficiency test attestation records for ten events in 2024 and 2025, lack of documentation, and interviews with laboratory staff, it was determined that required signatures to attest to the routine integration of proficiency test samples in the patient workload were not present on 2 of the 8 events reviewed. Survey findings follow: A) Review of the attestation forms for API Microbiology 2025 1st proficiency test event for bacteriology revealed that it was not signed by the lab director or designee. A) Review of the attestation forms for API Microbiology 2025 2nd proficiency test event for bacteriology revealed that it was not signed by the lab director or designee. C) In an interview, at 9:46 a.m.on 11/24/25, the technical consultant confirmed the API proficiency testing attestation forms identified above were not signed by the required personnel. 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 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of the laboratory's Individualized Quality Control Plan (IQCP) for Neisseria gonorrhoeae (NG) and Chlamydia trachmatis (CT) testing performed on the Cepheid GeneXpert system, Cepheid GeneXpert manufacturer's requirement, observation, lack of documentation, and interview with laboratory staff determined that the laboratory failed to perform positive and negative quality control (QC) samples as required by the manufacturer and the IQCP. Findings follow: A) The laboratory's IQCP for CT and NG testing performed on the Cepheid GeneXpert system states "external controls should be performed using ZeptoMetrix NATrol CT/NG external run controls (NATrol CT positive, NATrol NG., and NATrol CT/NG negative control) at the following intervals: 1. On each new lot/shipment of cartridges or concurrently with placing them into use for patient testing, 2. Monthly, 3. After major system maintenance or software upgrade." B) The manufacturer's manual for NG/CT testing on the Cepheid GeneXpert system calls for positive and negative controls to be run monthly and with each new lot/shipment of cartiridges. C) During a tour of the laboratory at 10:20 a.m. on 4/30/24, the surveyor noted that CT/NG cartridges currently in use was lot # 35104 and the box of cartridges was marked "QC run 1/5 /24". D) Upon request the laboratory was unable to provide documentation of QC 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 -- results for cartridge Lot #'s 35104 and the only CT/NG QC available performed on 1/5 /24 was for lot # 35329. E) Review of laboratory patient results revealed that CT/NG testing was performed and reported on patient # 1 (on a separate patient identification list) on 4/30/24. F) In an interview on 4/30/24 at 10:40 a.m., the laboratory staff member # 2 (on the form CMS 209) stated that QC was inadvertently performed on the wrong lot number of CT/NG cartridges and QC was not performed on lot # 35104 and should have been. -- 2 of 2 --