Kane County Hospital

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on proficiency test records and interview with the Technical Supervisor (TS), the laboratory failed to verify the accuracy of d-Dimer results of two of eight proficiency testing (PT) events that were reviewed, from first event 2022 to second event 2024. The laboratory performs 144 d-Dimer tests annually. Findings include: 1. Record review of API 2024 Chem-Core-1st and 2nd PT events reveled samples CM- 02, CM-06, and CM-07 were not graded because there was not an appropriate peer group and less than 10 participants. 2. Record review of laboratory documentation failed to produce laboratory verification of the accuracy of the d-Dimer results that were not graded by the PT program. 3. In an interview conducted with the TS on 09/27 /2024 at approximately 11:56 A.M. confirmed that the laboratory failed to verify the accuracy of the d-Dimer PT samples that were not evaluated by the PT program due to lack of peer group and less than 10 participants. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review, direct observation, and interview with the technical supervisor, humidity of the laboratory was not monitored. The laboratory performs approximately 160,732 tests annually. Findings include: 1. Record review did not include recorded humidity on the maintenance log. There was no written policy for the monitoring of room humidity. 2. No hygrometer was present in the laboratory during observation on 09/29/2021 at approximately 4:00 PM. 3. Sysmex CA-600 Series analyzer requires 30-80% humidity. 4. In an interview on 09/29/2021 at approximately 4:30 PM, the technical supervisor confirmed humidity was not monitored. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result 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 -- reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on records review, direct observation, and interview with the Technical Supervisor (TS) the laboratory failed to perform function checks on all laboratory pipettes and thermometers. Laboratory thermometers are used to insure the stability of calibrators, controls, and reagents stored in freezers and refrigerators. Laboratory pipettes are used for various proposes throughout the laboratory. The laboratory performs approximately 160,732 test annually. Findings include: 1. Record review found no pipette calibration and function checks for precision and accuracy of laboratory pipettes and laboratory thermometers. 2. Record review did not find a policy for regular pipette function checks and laboratory thermometers. 3. Visual inspection on 09/30/2021 at approximately 10:00 AM, showed no calibration stickers on thermometers or pipettes. 4. The lab failed to follow the manufactures instructions for calibrating and performing function checks for laboratory pipettes and laboratory thermometers. 5. In an interview on 09/30/2021 at approximately 10:03 am, the TS confirmed that the lab does not perform function checks of laboratory pipettes and thermometers. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Supervisor (TS) the laboratory failed to properly complete cross match tag paperwork for issuing a blood unit to patient. The laboratory performs tests for approximately 60 transfusions annually. Findings include: 1. Record review showed on 08/28/2020 component tag paperwork was not completed prior to issuing blood unit to the patient. 2. The laboratory did not follow its pretransfusion testing procedure on documenting paperwork prior to checking out blood units. 3. In an interview on 09/30/2021 at approximately 11:30 am, the TS confirmed that the paperwork had not been filled out properly before issuing the blood unit to the patient. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and confirmation by staff, the laboratory failed to retain and be able to retrieve routine chemistry instrument printouts for 2 of 5 College of American Pathology (CAP) proficiency testing events and 1 of 3 neonatal bilirubin CAP proficiency testing events reviewed. The laboratory performed proficiency testing 3 events per year for 9 proficiency testing modules. Findings include: 1. Proficiency records for EXL instrument printouts could not be located for routine chemistry testing for CAP modules C-A and C-C of 2018; or NB -A of 2019. 2. In an interview conducted on 05/15/2019 at approximately 6:45 P.M. the laboratory manager stated the laboratory recorded the date the proficiency tests were performed above the testing person's signature on the proficiency attestation statement in order to find the printouts. The dates recorded on the attestation statements were located and the complete contents of the instrument printouts were reviewed without finding proficiency test's results on the printouts for CAP events C-A and C-C of 2018 and neonatal bilirubin NB-A of 2019. The laboratory manager confirmed the printout retention did not allow for easily locating the laboratory's results. 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 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 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on patient test records review, quality control records review, and interview with staff, the laboratory failed to perform two levels of quality control each day of testing for 2 of 20 test days reviewed, [on 11/01/2017 for Complete Blood Counts (CBC) and on 01/23/2019 for Low Density Lipoprotein Cholesterol (LDL)]. Findings include: 1. Patient test records review included documentation patient 57522 was tested for a CBC on 11/01/2019. The laboratory failed to document they performed at least 2 levels of CBC quality control on 11/01/2017. Patient test records review included documentation patient 13211 was tested on 01/23/2019 for LDL Cholesterol as part of a lipid profile. The patient results were reported as 59 mg/dl. The laboratory quality control records failed to include at least two levels of quality control were performed on 01/23/2019. 2. In an interview with laboratory staff on 05/15/2019 at approximately 5:50 P.M. staff confirmed CBC quality control was not recorded on 11 /01/2017 and the laboratory recorded only one (the normal) level of LDL Cholesterol control on 01/23/2019. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on immunohematology blood release records review, lack of documentation and confirmation by staff, the laboratory failed to follow Federal Food and Drug Administration (FDA) requirements and document a visual inspection of packed Red Blood Cells was performed prior to issue for 3 of 8 units issued that were reviewed for blood issued between May 15, 2017 and May 15, 2019. The laboratory issued lees than approximately 30 units per year. Findings include: 1. Immunohematology records review failed to include documentation the laboratory followed FDA requirements to perform a visual inspection of stored packed red blood cells at the time of issue for one blood unit issued on on 02/15/2019 for patient medical record number (MRN) 3701, on 11/29/2018 for patient MRN 33756, and on 03/25/2019 for patient MRN 19467. 2. In an interview with staff on 05/15/2019 at approximately 4: 00 P.M., staff confirmed they failed to document they performed a visual inspection of the packed red blood cells at the time each unit was issued. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to document 2 of 2 testing personnel were evaluated annually for 1 of 2 years of testing reviewed in 2017. Findings include: 1. The laboratory lacked documentation the technical supervisor evaluated testing personnel in 2017 for competency to perform Chemistry, Hematology, and Immunohematology testing. 2. In an interview on 05/15 /2019 at approximately 6:00 P.M., the current Hematology and Chemistry technical supervisor confirmed testing personnel were not evaluated in 2017 for competency to perform laboratory testing in any specialty. -- 3 of 3 --