Cook Hospital Tower Lab

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 --