Summary:
Summary Statement of Deficiencies D0000 A validation survey was performed on August 12th, 2026 by the State of Illinois Department of Public Health. The laboratory was found to be out of Compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003) for the following condition- level deficiencies: 493.1421 Condition: Laboratores performing moderate complexity testing: Testing Personnel D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on direct observation, record review, and interviews with technical consultant (TC) #2 ; the laboratory failed to perform calibration verification at least once every six months for iSTAT Chem 8+ testing. Findings Include: 1. Upon the tour of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- facility on 08-12-2026, at 11:28 am, the i-Stat analyzer (SN: (21)403955) was identified performing Chem8 + cartridges that includes Sodium, Potassium, Chloride, Carbon Dioxide, Blood Urea Nitrogen, Creatine, Glucose and Ionized Calcium. 2. On survey date 08/12/26 at 11:30 am, TC#2 stated calibration verification materials are to be performed every six months. 3. Review of laboratory policies and procedures revealed the policy titled, "Basic Metabolic Panel with Ionized calcium (CHEM 8 +) ", which stated, "Calibration verification; 1. On any new or replace device before clinically used. 2. Every 6 months following CLEW update." 4. The calibration verification records for the iSTAT Chem 8+ confirmed calibration verifications were performed: 09-06-2024 09-06-2025 This showed a greater than six-month gap from the 09-06-2024 calibration verification to the 09-06-2025 calibration verification. 5. On survey date 08/12/2026, at 12:36 pm, TC #2 confirmed that the laboratory failed to perform the required calibration verification in 2025 at least once every six months for iSTAT Chem 8+ testing. 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: Based on review of personnel records, lack of academic records, and interview with technical consultant #2; the laboratory failed to have qualifying academic records for two of ten testing personnel (TP) listed on the CMS-209 for moderate complexity testing in the subspeciality of Routine Chemistry and the specialty of Hematology. See 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 (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records, lack of academic records, and interview with technical consultant #2; the laboratory failed to have qualifying academic records for two of ten testing personnel (TP) listed on the CMS-209 for moderate complexity testing in the subspecialty of Routine Chemistry and the specialty of Hematology. -- 2 of 3 -- Findings include: 1. Review of personnel educational documentation revealed two of ten TP (TP #4, TP #7) failed to meet the education requirements to qualify as a moderate complexity TP. TP #4 - No foreign equivalency documentation provided. TP #7 - No qualifiable educational documentation (degree and/or transcripts) provided. 2. Interview with technical consultant #2 on 08/12/2026 at 9:26 am confirmed the laboratory did not have the required education documentation for TP #4 and TP #7 to perform moderate complexity testing in the subspecialty of Routine Chemistry and the specialty of Hematology. -- 3 of 3 --