Phoebe Sumter Medical Center - Blood Gas Lab

Summary Statement of Deficiencies D0000 A recertification survey was performed on .April 25, 2025. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the College of American Pathology (CAP), Proficiency Testing (PT) provider documents and staff interview, the laboratory failed to rotate PT performance between each testing personnel. Only two out of 26 TP had performed the PT since 2023. Findings: 1. Review of the CAP PT documents for the years 2023, 2024, and first event of 2025 revealed only two TP had signed the Attestation Statement as performing the testing on the PT samples. PT testing should be rotated between all TP that perform patient testing. 2. Interview with the General Supervisor (GS), on 4/25/2025, at approximately 1pm in the Laboratory confirmed the aforementioned statement. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 the Standard Operating Policy and Procedure (SOP), Testing Personnel (TP) Competency documents and staff interview, the Laboratory failed to complete training documents for TP-26 on the Laboratory Personnel Report, Centers for Medicare and Medicaid Services (CMS) form 209(209). Findings: 1. A review of TP competencies revealed that the laboratory did not perform a competency on TP-26 (see CMS personnel form 209). A reeview of the Employee Training and Competency SOP confirmed there was no documentation about performing training/competency on a contracted employee working at the facility. There were no training documents available for TP-26. Training and Competency must be verified at the facility that the TP is performing testing. 2. Interview with the General Supervisor on 04/25/2025 at approximately 1 pm in the Laboratory, confirmed the aforementioned statement. It was also stated that the contracted TP had training documents from the Provider office, but there was not a copy available on site. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of the Standard Operating Policy and Procedure (SOP), Testing Personnel (TP) Competency documents and staff interview, the Laboratory Director (LD) failed to have completed training documents for TP-26 on the Laboratory Personnel Report, Centers for Medicare and Medicaid Services (CMS) form 209(209). Training and Competency documents must be performed on the TP at the facility that the work is being performed. Findings: 1. Review of TP competencies, the LD did not verify that training/competency was performed on TP-26 on the 209 forms. Review of the SOP pertaining to Employee Training and Competency there was no mention about performing training/competency on a contracted employee that is working at the facility. There was no Training documents available for TP-26. 2. Interview with the General Supervisor on 04/25/2025 at approximately 1 pm in the Laboratory, confirmed the aforementioned statement. It was also stated that the contracted TP had training documents from the Provider office, but there was not a copy available on site. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 31, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: 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 review of the Quality Control (QC) procedure and QC documents for the Abbott iStat analyzer (iSTAT) for testing Arterial Blood Gasses (ABG's), and staff interview, the laboratory failed to document two controls of different concentrations at least once each day, patient specimens are assayed. Findings: 1. Review of the QC procedure and QC documents for the iSTAT, the laboratory did not document two controls of different concentrations each day of patient testing for ABG's. 2. Interview with staff #1 (CMS 209 form) on January 31, 2019, at approximately 1:30 pm in the Hospital Administrative Conference room, confirmed that the laboratory was not performing two levels of different concentrations at least once each day, patient specimens are assayed. It was also confirmed that an Individualized Quality Control Plan (IQCP) had not been 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 1 --