South Carolina Oncology Associates Pa

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on March 25, 2026, at the laboratory of South Carolina Oncology Associates (SCOA) by the South Carolina Department of Public Health (SC DPH) Bureau of Nursing Homes and Medical Services.The laboratory was found to be out of compliance with Medicare condition at 42 CFR Part 493, CLIA requirements for laboratories. The following is a list of deficiencies as a result of the March 25, 2026, recertification survey: D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboratory failed to documment comparisons for test results between testing personnel (TP) for 1 of 2 years reviewed (2024). Finding included: 1. Review of the CMS 209 reveals 6 TP for high complexity testing. 2. The surveyor requested documentation and the laboratory was unable to provide evidence of comparison studies performed by all TP for 2024. 3. In an interview with the General Supervisor (GS) on March 25, 2026, at 1: 50 pm in the laboratory, the findings were confirmed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems 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 -- identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboratory failed to document communcations of issues occuring in the laboratory. Findings included: 1. Review of laboratory's "Quality Assurance Monitors" reveals the requirement for documented communication between the laboratory and the individual ordering the test to be performed. 2. The surveyor requested and the laboratory was not able to provide documentation of communication to the laboratory staff of activites occuring in the laboratory. 3.In an interview with the GS on March 25, 2026, at 1:50pm in the laboratory, the findings were confirmed. -- 2 of 2 --

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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: During an onsite recertification survey on 1/10/2018, based on direct observation, record review, and testing personnel interview, the laboratory failed to document twice a year comparison for PT/INR testing on the Abbott I-Stat and ACL coagulation anlyzer for the year 2017. Findings include: 1. During the laboratory tour at 9:45 am, Abbott I-Stat meters were observed in the laboratory. Testing personnel stated that PT /INR was being performed on the I-Stat. 2. Review of the installation and validation records for the I-Stat revealed that PT/INR testing on the instrument began in January 2017. A test method comparison was performed in January 2017 as part of the instrument validation. 3. Testing personnel stated during an interview at 1:45 pm that primary PT/INR testing was being performed on the I-Stat, and that the ACL was being used for confirmation or back up. 4. During the exit interview at 3:30 pm, testing personnel confirmed that an instument comparison was not performed twice per year as required. 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 --