Illinois State University Student Health Service

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, Wisconsin State Laboratory Hygiene (WSLH) proficiency testing (PT) records, lack of documentation, and interview with the general supervisor (GS); the laboratory failed to ensure accuracy of 89 of 89 analytes not evaluated by the PT provider for six of six PT events in the specialties of hematology and microbiology in 2023 through the date of survey, 05/01/2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Proficiency Testing", which stated, under "Proficiency Processing:", "10. If results are not within limits, an investigation will be performed." 2. Review of WSLH comparative evaluation summaries for the following PT events of 2023 through 2025 revealed the following un-graded PT samples: PT Event: Analyte: Sample: 2023 Event 2 - Hematology RDW-CV %* AF5-6 2023 Event 2 - Hematology RDW-CV % AF5-7 2023 Event 2 - Hematology RDW-CV % AF5-8 2023 Event 2 - Hematology RDW-CV % AF5-9 2023 Event 2 - Hematology RDW-CV % AF5-10 2023 Event 3 - Hematology RDW-CV % AF5-11 2023 Event 3 - Hematology RDW-CV % AF5-12 2023 Event 3 - Hematology RDW-CV % AF5-13 2023 Event 3 - Hematology RDW-CV % AF5-14 2023 Event 3 - Hematology RDW- CV % AF5-15 2024 Event 1 - Hematology RDW-CV % AF5-1 2024 Event 1 - Hematology RDW-CV % AF5-2 2024 Event 1 - Hematology RDW-CV % AF5-3 2024 Event 1 - Hematology RDW-CV % AF5-4 2024 Event 1 - Hematology RDW- CV % AF5-5 2024 Event 1 - Hematology MPV AF5-1 2024 Event 1 - Hematology MPV AF5-2 2024 Event 1 - Hematology MPV AF5-3 2024 Event 1 - Hematology MPV AF5-4 2024 Event 1 - Hematology MPV AF5-5 2024 Event 2 - Hematology 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 -- Leukocytes AF5-6 2024 Event 2 - Hematology Leukocytes AF5-7 2024 Event 2 - Hematology Leukocytes AF5-8 2024 Event 2 - Hematology Leukocytes AF5-9 2024 Event 2 - Hematology Leukocytes AF5-10 2024 Event 2 - Hematology MCH*** AF5- 6 2024 Event 2 - Hematology MCH AF5-7 2024 Event 2 - Hematology MCH AF5-8 2024 Event 2 - Hematology MCH AF5-9 2024 Event 2 - Hematology MCH AF5-10 2024 Event 2 - Hematology RDW-CV AF5-6 2024 Event 2 - Hematology RDW-CV AF5-7 2024 Event 2 - Hematology RDW-CV AF5-8 2024 Event 2 - Hematology RDW-CV AF5-9 2024 Event 2 - Hematology RDW-CV AF5-10 2024 Event 2 - Hematology RDW-SD**** AF5-6 2024 Event 2 - Hematology RDW-SD AF5-7 2024 Event 2 - Hematology RDW-SD AF5-8 2024 Event 2 - Hematology RDW-SD AF5-9 2024 Event 2 - Hematology RDW-SD AF5-10 2024 Event 2 - Hematology MPV***** AF5-6 2024 Event 2 - Hematology MPV AF5-7 2024 Event 2 - Hematology MPV AF5-8 2024 Event 2 - Hematology MPV AF5-9 2024 Event 2 - Hematology MPV AF5-10 2024 Event 2 - Microbiology Sensitivity Ciprofloxacin 2024 Event 2 - Microbiology Sensitivity Gentamicin 2024 Event 2 - Microbiology Sensitivity Levofloxacin 2024 Event 3 - Hematology Leukocytes AF5-11 2024 Event 3 - Hematology Leukocytes AF5-12 2024 Event 3 - Hematology Leukocytes AF5-13 2024 Event 3 - Hematology Leukocytes AF5-14 2024 Event 3 - Hematology Leukocytes AF5-15 2024 Event 3 - Hematology MCHC****** AF5-11 2024 Event 3 - Hematology MCHC AF5-12 2024 Event 3 - Hematology MCHC AF5-13 2024 Event 3 - Hematology MCHC AF5-14 2024 Event 3 - Hematology MCHC AF5-15 2024 Event 3 - Hematology RDW-CV % AF5-11 2024 Event 3 - Hematology RDW- CV % AF5-12 2024 Event 3 - Hematology RDW-CV % AF5-13 2024 Event 3 - Hematology RDW-CV % AF5-14 2024 Event 3 - Hematology RDW-CV % AF5-15 2024 Event 3 - Hematology RDW-SD AF5-11 2024 Event 3 - Hematology RDW-SD AF5-12 2024 Event 3 - Hematology RDW-SD AF5-13 2024 Event 3 - Hematology RDW-SD AF5-14 2024 Event 3 - Hematology RDW-SD AF5-15 2024 Event 3 - Hematology MPV AF5-11 2024 Event 3 - Hematology MPV AF5-12 2024 Event 3 - Hematology MPV AF5-13 2024 Event 3 - Hematology MPV AF5-14 2024 Event 3 - Hematology MPV AF5-15 2024 Event 3 - Microbiology Sensitivity Nitrofurantoin 2025 Event 1 - Hematology RDW-CV % AF5-1 2025 Event 1 - Hematology RDW- CV % AF5-2 2025 Event 1 - Hematology RDW-CV % AF5-3 2025 Event 1 - Hematology RDW-CV % AF5-4 2025 Event 1 - Hematology RDW-CV % AF5-5 2025 Event 1 - Hematology Platelets AF5-1 2025 Event 1 - Hematology Platelets AF5-2 2025 Event 1 - Hematology Platelets AF5-3 2025 Event 1 - Hematology Platelets AF5-4 2025 Event 1 - Hematology Platelets AF5-5 2025 Event 1 - Hematology Fecal smear PM-2 2025 Event 1 - Microbiology KOH******* PM-3 2025 Event 1 - Microbiology Sensitivity Ciprofloxacin 2025 Event 1 - Microbiology Sensitivity Trimethoprim/Sulfamethoxazole 2025 Event 1 - Microbiology Strep Culture TU-4 *RDW-CV = Red Cell Distribution Width - Coefficient variable **MCV = Mean Corpuscular Volume ***MCH = Mean Corpuscular Hemoglobin ****RDW-SD = Red Cell Distribution Width - Standard Deviation *****MPV = Mean Platelet Volume ******MCHC = Mean Corpuscular Hemoglobin Concentration *******KOH = Potassium Hydroxide 3. Review of laboratory records found no documented review of the ungraded PT analytes in the specialties of hematology and microbiology 2023 through 2025. 4. Interview with the GS on 05/01 /2025, at 11:55 am, confirmed the laboratory failed to ensure accuracy of 89 of 89 analytes not evaluated by the PT provider for six of six PT events in the specialties of hematology and microbiology in 2023 through the date of survey, 05/01/2025. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) -- 2 of 3 -- (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. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the general supervisor (GS); the laboratory failed to have a system in place that twice a year evaluates and defines the comparison of test results between three of three Cepheid GeneXpert DX instruments used for Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) testing in the specialty of microbiology from 2023 through the date of testing, 05/01/2025. Findings include: 1. Upon a tour of the laboratory on 05/01/2025, at 9:53 am, three Cepheid GeneXpert DX Systems used for CT/NG microbiology testing were observed. Instrument: Serial Number: Cepheid GeneXpert A 820963 Cepheid GeneXpert B 844021 Cepheid GeneXpert C 844026 2. Review of the laboratory's procedure for Cepheid GeneXpert CT/NG testing identified that the procedure failed to address how the relationship between the three analyzers will be evaluated twice yearly. 3. Review of laboratory records found the laboratory lacked documentation for instrument-to- instrument test result comparisons between the three Cepheid GeneXpert instruments used for CT/NG testing. 4. Interview with the GS on 05/01/2025, 10:03 am, confirmed the laboratory failed to have a system in place that twice a year evaluates and defines the comparison of test results between three of three Cepheid GeneXpert DX instruments used for CT/NG testing from 2023 through the date of testing, 05/01 /2025. -- 3 of 3 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with technical supervisor (TS), the laboratory failed to establish and perform a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting for one of one biosafety cabinets in use for microbiology testing. Findings Include: 1. On 4/27/2022 at 2:00 p.m., surveyor observed expired certification date 11-16-2020 on LABGARD ES Class II, Type A2 Biological Safety Cabinet (BSC). Serial NO. 201434100820. IL State University #331100. 2. Review of laboratory records found no documentation that the laboratory recertifed the BSC by the next due date Nov - 2021, documented by CLEAN AIR FLOW, INC., P.O. BOX 725, Lincolnshire, IL 60069. 3. On 4/27 /2022 at 2:06 p.m., with TS confirmed the above findings. 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 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 direct observation, review of laboratory records, and interview with technical supervisor (TS) #2; the laboratory failed to perform verification studies for new specimens types (rectal and throat) performed on the Cepheid GeneXpert prior to reporting patient test results. Findings Include: 1. Direct observation of laboratory testing equipment on 9-10-2019, at 9:50 am, identified a Cepheid GeneXpert (Serial Number: 820963) used for bacteriology testing. 2. Review of Cepheid GeneXpert verification of performance documentation revealed the laboratory failed to perform verification studies for rectal and throat specimens used to test for Neisseria gonorrhoeae and Chlamydia. 3. Review of patient testing records for the Cepheid GeneXpert revealed the laboratory performed 4 rectal and 10 throat specimens for Neisseria gonorrhoeae and Chlamydia testing without performing verification studies for the new specimen types. 4. On survey date 9-10-2019, at 4:05 pm, the above findings were confirmed by TS#2. 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 --