Summary:
Summary Statement of Deficiencies D0000 Based on an unannounced validation survey, the laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780. Standard level deficiencies cited. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on the surveyor's direct observation, the review of the laboratory's records, the manufacturer's package inserts, liquid QC records from November 2025 to December 2025, and confirmed in an interview, the laboratory failed to have documentation of monitoring QC values over time for 3 of 4 analyzers performing moderate complexity tests for 2 of 2 months reviewed. The findings were: 1. The surveyor's direct observation on 03/25/2026 at 9:45 am in the lab revealed the lab performed moderate complexity chemistry tests on 3 analyzers. Piccolo Express Chemistry analyzer (SN: 0000P22554) performed MetLac 12 Panel iSTAT Chemistry analyzer performed CHEM8+ cartridge, G3+ cartridge, and PT/INR cartridge. Triage MeterPro (SN: 00101232WW) performed cardiac panel and D-Dimer panel. 2. Review the laboratory's records revealed the laboratory restarted the chemistry moderate complexity tests on the following dates. Piccolo Express Chemistry analyzer: June 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 -- 2025 iSTAT Chemistry analyzer: CHEM8+ cartridge: June 2025 G3+ cartridge: March 2025 PT/INR cartridge included analyte of PT: November 2025 Triage MeterPro: Cardiac panel included analytes of CK-MB, troponin I, and myoglobin: February 2025 D-Dimer panel included analyte of D-Dimer: February 2025. 3. Review of the manufacturer's package inserts for iSTAT CHEM8+ cartridge (Art: 765874-00 Rev. D Rev. Date: 15-Oct-2021) and iSTAT G3+ cartridge (Rev. Date: 17- APR-2025 Art: 788330-00B) revealed CHEM8+ and G3+ performed total of 12 analytes. CHEM8+ cartridge ran 9 quantitative analytes: Sodium, Potassium, Chloride, Urea Nitrogen (BUN), Glucose, Ionized Calcium, Creatinine, Hematocrit, and total CO2. G3+ cartridge ran 3 quantitative analytes: pH, pO2, pCO2. 4. Review of the laboratory's chemistry analyzer's quantitative liquid QC records from November 2025 to December 2025 revealed no documentation of the laboratory monitoring the QC values over time for 3 of 4 analyzers performed moderate complexity tests for 2 of 2 months reviewed. 5. An interview on 03/25/2026 at 12:48 pm in the conference room, the technical consultant (as listed on CMS 209 form) confirmed the above findings. Key: QC=Quality Control PT=Prothrombin Time CMS=Center of Medicare and Medicaid Services -- 2 of 2 --