Core Laboratory

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of Comparison study records and interview with the Technical Consultant (TC)#2, the laboratory failed to evaluate the relationship between the 2 of 2 Abbott i-Stat analyzers from 06/16/2021 to date of survey. Findings: 1. At the time of inspection on 05/10/2023 at 9:21 am, review of Comparison study records revealed , the laboratory did not evaluate twice annually the relationship between test results using the different instruments for the 2 of 2 Abbott i-Stat analyzers for the following analytes: PT/INR Ph pCO2 pO2 Chloride Potassium Sodium Ionized Calcium tCO2 Lactate Creatinine Glucose BUN Hemoglobin Hematocrit. 2. The laboratory reported an annual testing volume of 650 for Chemistry and 800 for Hematology. (CMS-116) 3. The TC #2 confirmed the above findings on 05/10/2023 around 3:20pm. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory standard operation procedure (SOP), laboratory quality assessment (QA) policy, and interview with the technical supervisor (TS) #2, the laboratory failed to have QA procedures for monitoring different testing phases in 2018. Findings include: 1. The laboratory 2018 SOP lacks QA procedures to assess pre-analytical, analytical and post-analytical testing phases. 2. The laboratory had no other QA measures for these (3 of 3) testing stages in 2018. 3. The TS #2 confirmed above findings on 10/18/2018 at 11:30 AM. ====================================== 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 --