Piedmont Cancer Institute

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 26, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A tour of the testing facility during the survey revealed that the Laboratory Director (LD) failed to assure proper storage of reagents essential for test results reporting. THE FINDINGS INCLUDE: 1. A tour of the laboratory Reagent/ Supplies Storage Room #1 confirmed that the temperature and the humidity was not monitored to assure that the reagents/ supplies were stored as indicated by the manufacturers' requirements. 2. A tour of the laboratory Reagent/ Supplies Storage Room #2 confirmed that the temperature and the humidity was not monitored to assure that the reagents/ supplies were stored as indicated by the manufacturers' requirements. 3. A tour of the laboratory Storage Room #1 and #2 confirmed the manufacturer reagent storage requirements below: a) Becton Dickinson Blood Collection Vacutainer Tubes, Becton Dickinson Urine C&S Vacutainer Tubes, and Greiner Bio-One Blood Collection Vacutainer Tubes required storage at 2C - 25C temperatures; b) Guardant Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 360 CDx Specimen Collection Kits and Para Pak C&S Specimen Collection Medium required storage at 2C - 30C temperatures; c) Hemoccult Test Kits, Para Pak Zn-PVA Formalin, and Total Fix Ova & Parasite Fixative required storage at 15C - 30C temperatures; and d) Invitae Genetic Specimen Collection Kits required to storage at 18C - 25C temperatures. 4. An exit interview with Testing Personnel 2 (TP2), identified on the 2025 - CMS 209 Personnel Form, on March 26, 2025, at 3:00pm, in the back office review room, confirmed that the LD failed to assure proper storage of reagents essential for patient testing. 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 identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: A review of the 2023 - 2025 ABX Pentra 60 C+ Quality Control Records, 2023 - 2025 Quality Assurance Records and the CBC Analysis procedure confirmed that the Testing Personnel (TP) and Laboratory Director (LD) failed to follow

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 18, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on testing personnel (TP) competency document review and laboratory supervisor's interview, the laboratory director (LD) failed to ensure TP annual competencies were performed by qualified staff as required. Findings include: 1. TP document review revealed annual competencies for TPs# 1 - 3 and #5 (CMS 209) were not performed by the Technical Consultant(TC) who is also the laboratory director (LD) in 2019 and 2020. 2. An interview with the laboratory supervisor, TP #2 (CMS209) on 03/18/2021 in a break room room at approximately 12:25 p.m. confirmed the aforementioned annual competencies were not performed in 2019 and 2020 by the (TC) who is also the laboratory director. 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 --