Providence Medical Center

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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 reporting. (b)(2)(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 review of the Ortho immunohematology maintenance and quality control records and confirmed by the laboratory manager the laboratory failed to perform weekly cleaning on the Ortho dispensers from 1/1/2025 - 6/4/2025. Findings are: 1. Review of the Ortho immunohematology maintenance and quality control records indicate weekly cleaning of the Ortho dispensers to be performed weekly. 2. Review of the Ortho immunohematology maintenance and quality control records from 1/1 /2025 - 6/4/2025, revealed cleaning of the Ortho dispensers was performed on 1/30 /2025 and 4/2/2025. 3. Interview with the laboratory manager on 6/4/2025 at 12:03 PM, confirmed the laboratory did not perform weekly cleaning if the Ortho dispensers from 1/1/2025 - 6/4/2025. 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 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 surveyor review of list of tests performed, interview with the laboratory manager, and lack of documentation the laboratory failed to verify performance specifications on four moderate complexity test kits. 1. Review of the list of tests performed, presented by the laboratory, included four new moderate complexity test kits. The four new moderate complexity test kits include: Test kit #1 giardia /cryptosporidium Test kit #2 campylobacter Test kit #3 shiga toxin producing escherichia coli Test kit #4 lactoferrin 2. Interview with the laboratory manager on 5 /17/2023 at approximately 3:00 pm confirmed patient testing began on June 2022 for test kit #1 giardia/crytosporidium, test kit #2 campylobacter, test kit #3 shiga toxin producing escherichia coli, and test kit #4 lactoferrin. 3. Interview with the laboratory manager on 5/17/2023 at approximately 3:00 pm the laboratory manager indicated the laboratory manager did not know if the laboratory had verified performance specification for test kit #1 giardia/cryptosporidium, test kit #2 campylobacter, test kit #3 shiga toxin producing escherichia coli, and test kit #4 lactoferrin. 4. No documentation of verification of performance specifications was found during the survey. 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 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 concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of quality control (QC) records, review of patient log records, and interview with the general supervisor the laboratory failed to perform daily QC for d-dimer and human chorionic gonadotropin (HCG) quantitative testing performed. Findings are: 1. Review of external QC records from September 2020 through July 2021 revealed QC performed once every twenty eight days or new lot for d-dimer. 2. Review of patient logs revealed patient testing was performed starting September 2020 for d-dimer. 3. Review of external QC records from October 2020 through July 2021 revealed only one level of QC performed every fourteen days or new lot for HCG, quantitative. 4. Review of patient logs revealed patient testing was performed starting October 2020 for HCG, quantitative. 5. Interview with the general supervisor on 7/28/2021 at 1:25 PM confirmed the laboratory had not performed QC testing at least once a day when patient specimens are tested. The general supervisor confirmed no individual quality control plan had been implemented for d-dimer and HCG, quantitative. 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the list of tests performed, review of proficiency testing, and interview with general supervisor at 10:15 AM on 6/13/2019, the laboratory failed to verify the accuracy of wet preps for 2017 and 2018. Findings are: 1. Review of the list of tests performed and interview with general supervisor revealed wet preps performed at this laboratory with an annual volume of 24 tests. 2. Review of proficiency testing for all 3 events of 2017 and 2018 revealed a lack of participation for wet preps. 3. The general supervisor confirmed lack of participation and lack of comparison with another lab for 2017 and 2018 for wet preps. 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. This STANDARD is not met as evidenced by: Based on review of the CMS 209, competency evaluations for 2017 and 2018, and an interview with general supervisor at 11:00AM on 6/13/2019, the laboratory failed to perform competency evaluations on 1 of 6 high complexity testing personnel for both 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 -- years. Findings are: 1. The CMS 209 form completed by the laboratory revealed 6 high complexity testing personnel performing patient testing. 2. Review of competency evaluations for 2017 and 2018 revealed 1 high complexity testing personnel had no annual competencies performed for 2017 and 2018 3. Interview with the general supervisor confirmed the competency evaluations for 1 high complexity testing personnel had not been performed for 2017 and 2018. -- 2 of 2 --