Kansas Medical Center, Llc

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Proficiency Institute (API) for 2023 and to date of survey 2024, and interview with general supervisor (GS) #3, the laboratory failed to evaluate its unacceptable proficiency testing results for seven analytes in five test events for 2023. Findings: The following samples were scored unacceptable by API. No documentation of the laboratory's evaluation was provided at the time of survey. Listed by event, analyte- sample ID. 1. 2023 Chemistry-Core 2nd Event-Hemoglobin (EG7+)- IB-08. 2. 2023 Chemistry- Core 3rd Event-pO2 (EG7+)- IB-13. 3. 2023 Hematology/Coagulation 2nd Event- Eos %, Lymph %, Mono %, Neutrophil %- XE-08, APPT-COA-08. 4. 2023 Microbiology 2nd Event-RSV A-RSP-07, Human Rhinovirus/Enterovirus-RSP-08. 5. 2023 Microbiology 3rd Event-C. Difficile Toxin- CDF-12. RSV-RSP-12. 6. Interview with the GS #3 on 10/22/24 at 12:45 p.m. confirmed the laboratory failed to evaluate its unacceptable proficiency testing results for seven analytes in five test events for 2023. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on a review of PT records from API and interview with GS #3, the laboratory failed to evaluate its proficiency testing results that were not scored by the PT program for four of fifteen events in 2023 and 2024. Findings: Review of PT results from API for 2023 and 2024 revealed the following ungraded results with no evaluation provided at the time of survey. 1. 2023 Hematology/Coagulation 3rd event- ten ungraded results for: a. Fibrinogen: samples COA-06, 07, 08, 09 and 10. b. Blood Cell ID: samples ECI-06, 07, 08, 09, and 10. 2. 2023 Immunology /Immunohematology 3rd Event for Compatibility: sample SER-12. 3. 2023 Microbiology 2nd Event-two ungraded results for: a. Legionella pneumophilia: sample RSP-09 b. Influenza A: sample RSP-10 4. 2023 Microbiology 3rd Event-two ungraded results for: a. Coronavirus: sample RSP-11 b. Parainfluenza Virus: sample RSP-12. 5. Interview with GS #3 on 10/22/24 at 12:45 p.m. confirmed the laboratory failed to evaluate its proficiency testing results that were not scored by the PT program for four of fifteen events in 2023 and 2024. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 the review of proficiency testing (PT) records from American Proficiency Institute (API), the laboratory failed to successfully participate in PT under the specialty Immunohematology for the regulated analyte: Compatibility Testing. (Refer to D2181) D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based upon the review of PT results from API and phone interview, the laboratory failed to successfully participate in PT for the regulated analyte: Compatability Testing. Findings: 1. Review of Second Event 2022 revealed a score of 80% for Compatability Testing. 2. Review of Third Event 2022 revealed a score of 80% for Compatability Testing. 3. The laboratory manager on 2/3/23 at 12:30 pm in phone interview confirmed the laboratory failed to successfully participate in PT for the regulated analyte: Compatability Testing. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a lack of available documentation and confirmed during interview with the Technical Consultant (TC), the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. Findings: 1. Upon review of the laboratory procedures, the current Laboratory Director (LD) did not approve, sign, and date the laboratory procedure/policy for: 2 of 2 procedures in the laboratory at time of survey. 2. The following procedures were not signed by the current LD: a. LAB 6.04 ACL Elite b. SYSMEX XE-5000 3. Interview with the TC on December 13, 2022 at 11:22 a.m. confirmed, the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of quality control (QC) documentation and interview on the BioMerieux Biofire Respiratory Panel RP2.1, the laboratory failed to perform QC as required by CFR 493.1256: (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 and (d)(3) At least once each day patient specimens are assayed or examined performed. Findings: 1. The BioMerieux BioFire Respiratory Panel RP2.1 includes the following assays: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus/Entervirus, Influenza A, Influenza B, Parainfluenza Virus (1,2,3,4), RSV, Bordetella parapertusis, Bordetella pertusis, Chlamydia pneumoniae and Mycoplasma pneumoniae. 2. Review of the QC BioMerieux Biofire Respiratory Panel RP2.1 documentation for the months of October and November 2022, the laboratory only performed positive and negative QC on October 10, 2022, November 9, 2022 and November 21, 2022. No Individualized Quality Control Plan (IQCP) for the Respiratory Panel RP2.1 was available at the time of survey. 3. Review of the October and November 2022 QC logs revealed the laboratory failed to perform QC on any day of patient testing for the Biofire Respiratory Panel RP2.1 for 228 of 236 patients from October 1, 2021 through November 30, 2022 at time of survey. 4. Interview with Technical Consultant on 12/13/22 at 3:25 p.m. confirmed the laboratory failed to perform QC on the BioMerieux BioFire Respiratory Panel RP2.1 every day of patient testing from October 1, 2022 through November 30, 2022 and no IQCP was established. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of three Individualized Quality Control Plans(IQCP), the laboratory does not have procedures available that have been approved, signed, and dated by the current laboratory director. Findings: 1. Review of the following procedures reveals that the current laboratory director has not approved, signed and dated the procedures prior to use in patient testing: A. IQCP plans for Abbott I-STAT BNP, troponin I and Chem 8+ 2. Confirmed during interview with the Technical Supervisor on March 6, 2019 @1115. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: The Condition of technical consultant was not met when the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart (refer to D6046) D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) 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 -- (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: Based on review of competencies and interview withTechnical Consultant on March 6, 2019 at 11:20 AM confirmed the technical consultant failed to evaluate and document competency for testing personnel #2 for 2018 . ***This is a repeat deficiency, previously cited on July 12, 2017 -- 2 of 2 --