Orthopaedic Hospital Of Wisconsin, Llc

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of quality control records and the IQCP (Individualized Quality Control Plan) and interview with the Technical Consultant, the laboratory did not test control material on one of two iSTAT analyzers each month. Findings include: 1. Review of iSTAT quality control records for June through August 2023 showed the laboratory did not test external control materials monthly for each of the three test cartridges (CG8+, CHEM8+ and Troponin) on each of the two iSTAT analyzers except for the CHEM8+ in August. Reports showed the laboratory performed only the following iSTAT external quality control testing. Cartridge / Control Level / Analyzer Serial Number June 2023 CG8+ / 1, 2 & 3 / 334760 Troponin / 1 & 2 / 334760 CHEM8+ / 1 & 3 / 334760 July 2023 CG8+ / 1 & 3 / 303510 CG8+ / 2 / 334760 Troponin / 1 / 303510 Troponin / 2 / 334760 CHEM8+ / 1 & 3 / 334760 CHEM8+ / 2 / 303510 August 2023 CG8+ / 1, 2 & 3 / 334760 Troponin / 1 & 2 / 303510 CHEM8+ /1 & 3 /334760 CHEM8+ / 1 & 3 / 303510 2. Review of the 'Individualized Quality Control Plan', DX362, showed the plan required performance of external controls monthly for iSTAT testing. The plan did not exempt testing personnel from performing external control testing on both analyzers. 3. Interview with the Technical Consultant on July 22, 2024, at 1:30 PM confirmed 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 2 -- laboratory did not perform external quality control on each of the two analyzers monthly. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Technical Consultant, the laboratory did not perform an evaluation twice annually to define the relationship between testing on the two iSTAT analyzers in the last two of two years, 2022 and 2023. Findings include: 1. Review of laboratory records of comparison testing on the two iSTAT analyzers showed testing personnel performed a comparison in May 2022. The records did not show another comparison until July 2023. No other comparison records were available in 2022 or 2023. 2. Interview with the Technical Consultant on July 22, 2024, at 1:15 PM confirmed the laboratory did not have documentation to show the laboratory completed comparison testing twice annually on the two iSTAT analyzers in 2022 and 2023. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of test reports and interview with a technical consultant, the test report for one of one frozen section procedures performed since the last survey did not indicate the name and address of the laboratory locations where testing was performed. Findings include: 1. Review of the anatomic pathology test report for Patient 1 showed completion of a frozen section procedure on November 12, 2019. The report does not indicate the location of testing for the Gross Description, Frozen Section Diagnosis, or the Microscopic Description sections of the report. 2. Interview with a technical consultant, Staff C, on January 5, 2021 at 13:20 PM confirmed the laboratory director performed the frozen section analysis in this laboratory and that a reference laboratory performed additional testing. Further interview confirmed the report did not indicate the name and address of the performing laboratories. This is a repeat deficiency previously cited on March 21, 2011. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting 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 2 -- performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of personnel records and interview with a technical consultant, a technical consultant did not evaluate and document the performance of one of one new testing personnel at least semiannually during the first year the individual tested patient specimens. Findings include: 1. Review of personnel records showed Staff A was the only new testing personnel that had tested patient specimens for more than one year. Review of records for Staff A showed only one competency evaluation for moderate complexity test systems during 2020. No records of competency evaluation in 2019 are present. 2. Interview with a technical consultant, Staff B, on January 5, 2021 at 12:00 PM revealed Staff A started in December 2019 and confirmed a technical consultant did not complete competence evaluation for Staff A twice annually during the first year Staff A tested patient specimens. -- 2 of 2 --