St Lukes Hospital

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to test proficiency samples the same as patient samples for 2 of 3 hematology /coagulation events (2nd Event 2025 and 1st Event 2026). The laboratory performed 55 manual differentials in the past year. Findings include: 1. Review of the 2nd Event 2025 Hematology/Coagulation proficiency records, the morning of 07/15/26, indicated three testing personnel (#1, #2, and #3) documented blood cell identifications for BCI-06, BCI-07, BCI-08, BCI-09, and BCI-10 on 07/11/25, before the API online and postmark due date of 07/30/25. The testing personnel and lab director had signed the attestation statement documenting staff treated the samples the same as patients. 2. Review of the 1st Event 2026 Hematology/Coagulation proficiency records, at approximately 9:56 a.m. on 07/15/26, indicated three testing personnel (#2, #3, and #4) documented blood cell identifications for BCI-01, BCI-02, BCI-03, BCI-04, and BCI-05 on 03/16/26, before the API online and postmark due date of 04/01/26. The testing personnel and lab director had signed the attestation statement documenting staff treated the samples the same as patients. 3. During an interview at 10:14 a.m. on 07/15/26, testing personnel (#3) confirmed testing personnel review blood cell identifications together prior to submitting their proficiency testing findings. Testing personnel (#3) confirmed all testing personnel would not routinely review the same patient manual differentials. 4. Reviewed the afternoon of 07/15/26, the policy "Proficiency Test", dated 05/08/14, stated, ". . . All PT (proficiency testing) samples will be examined in the same manner as patient test samples using routine methods. . . . The laboratory may not test samples with greater frequency than it routinely tests patients. . . . All personnel performing PT testing 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 -- must sign the attestation statement that all PT samples were tested in the same manner they would test patient samples. . . ." 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. This STANDARD is not met as evidenced by: Based on observation, record review, and staff interview, the laboratory failed to twice annually compare and evaluate test results using different instruments for non- waived chemistry analytes for 1 of 1 year reviewed (2025). The laboratory performed 135 Creatine Kinase Myocardial Band (CKMB), 35 D-Dimer, and 191 Troponin tests in the past year. Findings include: 1. Observation of the laboratory, beginning at 8:13 a.m. on 07/15/26, showed two Triage meters (#1 and #2) on the chemistry bench. 2. Upon request on 07/15/26, the laboratory failed to provide evidence of CK-MB, D- Dimer, and Troponin twice annual test comparisons on Triage meter #1 and Triage meter #2. 3. During interview at 8:30 a.m. on 07/15/26, testing personnel (#3) confirmed the laboratory performed CK-MB, D-Dimer, and Troponin patient testing on both Triage meter #1 and Triage meter #2 and did not perform twice-annual comparisons on Triage meter #1 and Triage meter #2. 4. The laboratory failed to provide a policy regarding twice annual comparisons if a laboratory performs the same test using different methodologies or instruments. -- 2 of 2 --

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 record review, staff interview, and policy review, the laboratory failed to verify the precision for 3 of 3 new test methods (pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (potential of hydrogen /measurement of acid-base balance)) on the epoc blood gas analyzer in June 2020 before reporting patient results. The laboratory performed approximately 54 patient pO2, pCO2, and pH tests on the epoc blood gas analyzer since implementation. Findings include: 1. Reviewed at 1:50 p.m. on 06/01/22, the laboratory's 2020 performance specification verification records for the epoc blood gas analyzer lacked evidence the laboratory verified the precision performance specifications for pO2, pCO2, and pH. Upon request the laboratory failed to provide evidence of precision verification for pO2, pCO2, and pH. 2. During interview at 2:15 p.m. on 06/01/22, the laboratory supervisor (#1) confirmed the laboratory began patient testing on the epoc blood gas analyzer for pO2, pCO2, and pH in January 2021, and the laboratory did not have evidence the laboratory director and/or technical consultant had verified the performance specifications for precision. 3. Reviewed at 2:30 p.m. on 06/01/22, the policy "Establishment and Verification of Performance Specifications," dated 09/26 /19, stated, "This Clinical Laboratory shall verify each new test, method, or instrument prior to reporting patient results. These verifications shall be documented. . 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 -- . . Verification of Performance Specifications: Each laboratory that introduces an unmodified, FDA [Food and Drug Administration]-cleared or approved test system must do the following before reporting patient test results: Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: Accuracy Precision Reportable range of test results for the test system . . ." -- 2 of 2 --