Summary:
Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient results, review of the iSTAT chemistry analyzer quality control (QC), and interview with testing personnel (TP) #1, the laboratory failed to include two control materials of different concentrations for 2 of 2 patient testing days in 2024. Findings: 1. Review of patient results showed the laboratory performed patient testing on January 24, 2024 and February 7, 2024. 2. Review of the iSTAT chemistry analyzer QC results showed two acceptable levels of QC were not performed on January 24, 2024 or February 7, 2024 for the following analytes: hematocrit, glucose, blood urea nitrogen, sodium, chloride, potassium, ionized calcium, total carbon dioxide, creatinine, pH, partial pressure of carbon dioxide (PCO2), partial pressure of oxygen (PO2) and lactate. 3. Interview with the TP #1 on March 19, 2024 at 9:30 AM confirmed the laboratory failed to include two control materials each day of patient testing. 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 --