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Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the Abbott iStat System Verification analysis, performed by St. Charles hospital laboratory staff from 10/1/2009 through 11/12/2009 and interview with the Technical Consultant (TC), the laboratory failed to ensure the three (3) iStat instruments in use, were verified for performance before patient test results were reported. Findings include: 1. Upon receipt of the written iStat System Verification analysis, performed 10/01/2009 through 11/12/2009, it was noted that there were only two (2) analyzers involved in the study, not three (3). 2. The serial numbers for two (2) iStat analyzers in the verification study were listed as #333250 and #306269. 3. The serial numbers of the iStat analyzers reported to be in use at time of survey were #313383, #383188 and #434509. 4. The TC confirmed by email 06/30/2026 that the iStat verification performed from 10/01/2009 - 11/12/2009 was the sole verification analysis for the iStat instruments. 5. The laboratory performs 1100 tests using the iStat analyzers annually. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or 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 -- 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. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the Technical Consultant (TC), the laboratory failed to perform bi-annual test correlation studies on any of the three (3) Abbott iStat analyzers currently in use. Findings include: 1. Upon request for twice a year comparison studies for the analytes performed on the iStat analyzers, none could be produced. 2. Email with the TC confirmed that they have never performed bi-annual correlation studies on the iStat analyzers. 3. The laboratory performs 1100 tests using the iStat analyzers annually. -- 2 of 2 --

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Review of Personnel Records and discussion with the Staff reveals two (2) out of seventeen (17) testing personnels performing moderate complexity testing do not have their diplomas or transcripts of records on file. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Review of Personnel records reveals two (2) new testing personnels performing 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 -- moderate complexity testing do not have copies of their diplomas or transcripts of records on file. Findings include: 1. Two (2)) out of Seventeen (17) new testing personnel performing the Abbott I Stat Analyzer do not have copies of their diploma or transcript of records at the time of survey. 2. The Technical Consultant (TC) and Clinic Manager concur with these finding on 07/14/2020 at 15:00 PM. -- 2 of 2 --