Summary:
Summary Statement of Deficiencies D0000 The St. Charles Parish Hospital laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a validation survey on March 11, 2026. Standard level deficiency cited. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on the laboratory's Individualized Quality Control Plan (IQCP), record review, and in interview with testing person #4 (TP #4), the laboratory failed to perform quality control (QC) as stated in the laboratory's IQCP for one of one analyzer. Findings: 1. On 03/1/26 at 11:30 am, TP #4 confirmed the laboratory performed arterial blood gas (ABG) testing using the CG4+ cartridge and four Abbott iSTAT analyzers (serial numbers: 401959, 402282, 402283, 402048). 2. Review of the laboratory's IQCP (approved by the laboratory director on 01/07/2025), section "1. External Liquid Controls" stated, "The iSTAT used will be rotated periodically to a different serial number iSTAT so that all are used within a year." 3. Record review (2025) of external liquid QC of the four iSTATs revealed no documentation of external QC for one of four iSTAT analyzers (serial number 401959) in 2025. 4. Interview with TP #4 on 03/11/26 at 11:45 am, confirmed the findings. 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 --