Cook Hospital Tower Lab

Summary Statement of Deficiencies D0000 The Cook Hospital Tower Lab laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on September 3, 2026. The following standard-level deficiencies were cited: 493.1291 Test report 493.1413 Technical consultant responsibilities . D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to verify the accuracy of manually entered test results in 2025. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, and Hematology testing as indicated by the Laboratory Director (LD) during a tour of the laboratory at 1:05 p.m. on 09/03/26. 2. The following analyzers and equipment were observed as available for use during the tour: Sysmex XQ-320 hematology analyzer Abbott i-STAT blood analyzer Excyte 10 automated erythrocyte sedimentation analyzer MedTox Profile-V Drugs of Abuse test system Fisher Scientific Micromaster microscope 3. The laboratory manually entered test results from the above test systems and equipment into Meditech, the laboratory's Electronic Health Record software. 4. Accuracy verification of manually entered test results was required 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 -- monthly as established in the Result Reporting procedure located in the General Policies manual. 5. Documentation of the monthly manually entered test result verification was not found in 2025 laboratory records. The laboratory was unable to provide the missing documentation upon request. 6. The laboratory released approximately 8,536 patient test results annually as indicated on the Form CMS-116 provided by the laboratory on date of survey. 7. In an interview on 6:15 p.m. on 09/03 /26, the LD confirmed the above finding. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: 2025 CA missing med tox, excyte 10 and microscopic eams: man diff, KOH, WP, USed . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to ensure four of four tenured testing personnel were evaluated for test procedure competency in all testing areas in 2025. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, and Hematology testing as indicated by the Laboratory Director (LD) during a tour of the laboratory at 1:05 p.m. on 09/03/26. 2. The following analyzers and equipments were observed as present and available for use during the tour: Excyte 10 automated erythrocyte sedimentation analyzer (ESR) MedTox Profile-V Drugs of Abuse test system (UDS) Fisher Scientific Micromaster microscope for manual differential (Diff), KOH preparation (KOH), vaginal wet preparation (VWP) and urine sediment (USed). 3. Testing personnel were evaluated for competency in all testing areas semi- annually in the first year of testing and annually thereafter as established in the Quality Assurance Plan - Laboratory, Personnel section found in the General Policies manual. 4. Competency assessments for ESR, UDS, KOH, VWP, and USed testing were not included in the Evaluation of Competency and Performance forms completed for four of four tenured testing personnel in 2025. The laboratory was unable to provide the missing evaluations upon request. 5. In an interview at 2:45 p.m. on 09/03/26, the LD confirmed the above finding. . D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant (TC) failed to ensure two of four testing personnel (TP) were assessed annually through testing previously analyzed specimens, blind samples, or proficiency testing (PT) samples for two of four moderate complexity microscopic examinations performed in 2025. Findings are as follows: 1. The laboratory performed moderate complexity microscopic examination testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 1:05 p.m. on 09/03/26. 2. -- 2 of 3 -- An Fischer Scientific Micromaster microscope was observed as present and available for use during the tour: The laboratory performed Potassium Hydroxide (KOH) and Vaginal Wet Preparations (VWP) using this instrument. 3. Testing personnel were evaluated for competency in all testing areas semi-annually in the first year of testing and annually thereafter as established in the Quality Assurance Plan - Laboratory, Personnel section found in the General Policies manual. External proficiency testing (PT) samples were used to assess test performance. 4. Testing Personnel 1 (TP1) did not participate in KOH PT in 2025 for annual competency assessment and former TP FK (TPFK) did not participate in VWP PT in 2025 for annual competency assessment as indicated on American Proficiency Institute Attestation Statements reviewed on date of survey. 5. The laboratory was unable to provide alternative blind sample evaluation documentation completed in 2025 for TP1 and TPFK upon request. 6. In an interview at 2:45 p.m. on 09/03/26, the LD confirmed the above finding. . D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant (TC) failed to ensure initial training and competency evaluation was completed for one of four tenured testing personnel prior to testing patient specimens using a new Hematology analyzer in 2026. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 1:05 p.m. on 09/03/26. 2. A Sysmex XQ-320 hematology analyzer was observed as present and available for use during the tour of the laboratory. Complete Blood Count (CBC) with automated differential testing on this analyzer was implemented on 06/01/2026 as indicated by the LD and confirmed in laboratory records. 3. Sysmex XQ-320 initial training and competency evaluation documents for tenured Testing Personnel TP1, TP2, TP3, and former TP FK were not found during review of laboratory records. The laboratory was unable to provide these documents upon request. 4. The laboratory was given five business days to provide the missing training documentation. 5. In an interview at 5:30 p.m. on 09/03 /26, the LD confirmed the above finding. 6. In an email received at 5:58 p.m. on 09/10 /26, the LD provided training documentation for TP1, TP3, and former TP FK. No training documentation was provided for TP2. 7. 142 CBC patient test reports were released from 06/01/2026 through date of survey, 09/03/2026, as indicated by the LD in the email referenced above. See below. Month Number of patients tested June 59 July 39 August 33 September 11 . -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to successfully participate in Prothrombin Time PT under the specialty of Hematology in 2023. Finding are as follows: 1. The CMS CASPER Report 0155D and the API 2023 Hematology/Coagulation - 2nd Event Performance Summary and Comparative Evaluation were reviewed on September 13, 2023. The reports indicated the laboratory failed to achieve satisfactory performance for Prothrombin Time in two consecutive testing events in 2023 resulting in unsuccessful performance. See D2130. . 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the laboratory failed to achieve successful PT performance for Prothrombin Time testing in two consecutive PT events in 2023. Findings include: 1. The CMS CASPER Report 0155D, reviewed on September 13, 2023, indicated the laboratory failed to obtain a Prothrombin Time PT successful score of at least 80 percent in two consecutive testing events in 2023. 2. The API 2023 Hematology/Coagulation - 2nd Event Performance Summary confirmed the laboratory failed to obtain a Prothrombin Time PT score of at least 80 percent in two consecutive testing events in 2023. -2023 1st event 60% -2023 2nd event 60% -- 2 of 2 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure function checks for a Chemistry analyzer were performed and documented as required in 2022. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 1:15 p.m. on 01/12/23. 2. An Abbott i-STAT analyzer was observed as present and available for use during the tour. The laboratory used the CHEM8+ cartridge on the i-STAT analyzer for a Basic Metabolic Panel test with eight analytes. 3. Twice annual verification of the i-STAT thermal probe was required as established in the i-STAT CHEM8+ procedure found in the i-STAT manual. 4. Thermal probe verification was performed in November 2021 and December 2022 as indicated in laboratory records. 5. Thermal probe verification documentation from mid-2022 was not found in laboratory records. The laboratory was unable to provide this documentation upon request. 6. In an interview at 4:35 p.m. on 01/12/23, the LD confirmed the above finding. . 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 D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure a reference interval was consistent between a Chemistry procedure and a patient test report. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 8.10 a.m. on 04/01/21. 2. An Abbott i-STAT chemistry analyzer was observed as present and available for use during the tour. 3. A reference interval listed in the i-STAT Chem8+ Cartridge Basic Metabolic Panel procedure, located in the Lab Manual, was not consistent with that included on a patient test report reviewed on date of survey, as indicated below. Patient - adult female, aged 38 yrs, tested on 1-27-20 Procedure Report Chloride 98-118 mmol/L 99- 111 mmol/L 4. In an interview at 10:45 a.m., on 4/1/21, the LD confirmed the above finding. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: 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 -- . Based on document review and interview with laboratory personnel, the Technical Consultant failed to evaluate the competency of 5 of 5 testing personnel in 2019. Findings are as follows: 1. The laboratory performed Mycology, Parasitology, General Immunology, Chemistry and Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 8.10 a.m. on 04/01/21. 2. The Quality Assurance Plan - Laboratory procedure / Personnel Assessment section, located in the General Policies manual, indicated personnel were evaluated semi- annually during the first year of employment and annually thereafter. 3. 2019 competency assessments for TP1, TP2, TP3, TP4 and TP5 were not found during review of the laboratory's records. The laboratory was unable to provide the document upon request. 4. In an interview at 9:15 a.m. on 04/01/21, TP1 confirmed the above finding. . -- 2 of 2 --