Pediatric Partners Of Augusta, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on June 20, 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: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: A tour of the laboratory confirmed that expired reagents were being used for patient testing and resulting. THE FINDINGS INCLUDE: 1.A tour of the laboratory confirmed that several reagents and controls, in use for patient testing, were expired. a. HEMOCUE GLUCOSE 201 MICROCUVETTES: Expired 06/14/2025 b. GLUTROL AQ CONTROLS: Expired 06/30/2024 c. CHOLESTECH LDX MULTIANALYTE CONTROL: Expired 06/11/2021 d. BD SODIUM CITRATE TUBES: Expired 05/31/2025 e. BD URINE CULTURE VACUTAINER: Expired 02 /28/2025 2. An exit interview with the Laboratory Director, on June 20, 2025, at 12: 30pm, in the Conference Office confirmed that expired reagents, were in use for patent testing, at the time of onsite inspection, performed on 06/20/2025. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests 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 -- are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Quality Control Records, confirmed that the laboratory did not follow the Throat Culture quality control procedures for each day of use as required. THE FINDINGS INCLUDE: 1. A review of the 2023 - 2025 Quality Control Records revealed that daily quality control records for the Throat Culture Procedure were not monitored. 2. An interview with the Laboratory Director confirmed that testing personnel did not include quality controls with each patient testing batch. 3. An exit interview, with the Laboratory Director, on June 20, 2025, at 12:30pm, in the Conference Office confirmed that the laboratory did not include quality controls for the Throat Culture Procedure each day of use as required. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 23, 2023. 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 Proficiency Testing (PT) document review and staff interview, the laboratory failed to ensure that the Testing Personnel (TP) rotated for performing PT for 7 out of 7 Microbiology Events for 2021-2023. The Findings include: 1. American Proficiency Testing (API) PT document review revealed that Testing Personnel was not rotated for performing Proficiency Testing (PT) for Microbiology 1st, 2nd, and 3rd Events for 2021, Microbiology 1st, 2nd, and 3rd Events for 2022, and Microbiology 1st Event for 2023. Testing Personnel #1(CMS-209) performed all 7 events. 2. During an interview with the owner of the practice on May 23, 2023 at approximately 11:20 AM in the front office for the doctor's, confirmed that Testing Personnel was not rotated for Proficiency Testing for 7 out of 7 events ranging from 2021-2023 for Microbiology. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) 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 -- Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the general laboratory standard operating procedure manual (SOP) and staff interview, the laboratory failed to establish written instructions for sending specimens to an outside reference laboratory for testing. The findings include: 1. A review of the SOP confirmed that a written policy and procedure (to include collection, preservation, storage, transport, testing schedule times, and how to obtain additional assistance) was not available for staff to follow when sending specimens to a reference laboratories: Quest and LabCorp. 2. During an interview, with the owner of the practice, on May 23, 2023, at 11:30 AM, in the front office of the doctor's, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to reference laboratories or establish written instructions for sending specimens to an outside reference laboratory for testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 On September 10, 2021 an off site followup review was completed. The report revealed that the

Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on August 7, 2019. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory did not include required safety policies and procedures. Findings include: 1. SOP review revealed there was not a policy and procedure for the laboratory eyewash equipment. 2. An interview with the team leader in a medical office at approximately 12:45 p.m. on 8/7/2019 confirmed there was not an eyewash equipment policy and procedure in the SOP. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other 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 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)