Phelps Memorial Health Center

Summary Statement of Deficiencies 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 review of the laboratory's list of tests performed, lack of documentation, and interview with the laboratory manager the laboratory failed to have a system that twice annually evaluated the relationship between test results using different methodologies for troponin and creatinine since July 2023. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory was performing troponin and creatinine testing on the Vitros XT 7600 and on the iSTAT. 2. Review of documentation presented at time of survey revealed the laboratory performed a method comparison of troponin and creatinine on July 2023. 3. Interview with the laboratory manager on 4/15/2025 at 3:32 PM, confirmed patient testing was being performed in 2024 and 2025 using both methods, but the last evaluation of test methodologies for troponin and creatinine was performed on July 2023. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on surveyor review of the CMS-209 testing personnel report, review of competencies, and interview with the laboratory manager the technical consultant 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 -- failed to perform 2023 and 2024 annual competencies on two out of two testing personnel performing moderate complexity testing. Findings are: 1. Review of the CMS-209 laboratory personnel report revealed two testing personnel performing moderate complexity testing. 2. Review of annual competencies presented at time of survey revealed moderate complexity testing personnel #1 and #2, as listed on the CMS-209, did not have 2023 and 2024 annual competencies performed. 3. Interview with the laboratory manager on 4/15/2025 at 4:35 PM, confirmed moderate complexity testing personnel #1 and #2 did not have 2023 and 2024 annual competencies performed. -- 2 of 2 --

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 an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the laboratory manager, on 5/17/2024, it was determined the laboratory failed to successfully participate in proficiency testing for the analyte, compatibility testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the laboratory manager, on 5/17/2024, it was determined the laboratory failed to successfully participate in proficiency testing for the analyte, compatibility testing. Refer to D2181. 1. Desk review of the laboratory's 2023 and 2024 PT records revealed the analyte, compatibility testing, scores of less than one hundred percent for the following events: 2023 third event, score 80% 2024 first event, score 80% 2. Phone interview with the laboratory manager on 5/17/2024 at 11:24 AM, confirmed the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

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 surveyor review of proficiency testing (PT) records, a lack of verification records, and an interview with the general supervisor, the laboratory failed to have a system for verifying the accuracy of testing for neonatal, bilirubin. Findings are: 1. The laboratory's proficiency test results for 2020 did not include testing for neonatal, bilirubin. 2. Interview with the general supervisor on 6/24/2021 at 1:36 PM confirmed the laboratory had not enrolled in PT for neonatal, bilirubin, nor had the laboratory performed accuracy verification on these analytes. 3. Interview with the general supervisor on 6/24/2021 at 1:36 PM revealed the laboratory had performed eight neonatal, bilirubin tests in 2020. 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 --