Pediatric Partners Of Augusta Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 16, 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: 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) 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: Piedmont Augusta Hospital, LabCorp, Quest Diagnostics, and Mullins. 2. During an interview, on March 16, 2023, at 3:03 PM, with Testing Personnel#1 (CMS-209), in the conference room, confirmed that the laboratory did not have a written policy and procedure for staff to follow when sending specimens to reference laboratories. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the tour of the lab, observation, record review and interview, the laboratory failed to maintain required calibration records for the centrifuge. The Findings include: 1. Observation during the lab tour revealed the Drucker Diagnostics Horizon 642E centrifuge(Serial no.09964-0318) was last calibrated January 2022, the requirement for this centrifuge is to be calibrated annually. The manufacturer recommends that the Drucker Horizon 642E centrifuge is calibrated annually. 2. During an interview with Testing Personnel #1 (CMS 209) on March 16, 2022, in the lab at approximately 1:45PM, confirmed the centrifuge had not been calibrated since January 2022. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on lab report review and staff interviews, the laboratory failed to include all the required information on the in-house laboratory test reports. The Findings include: 1. Chart review for in-house patient laboratory test reports for the urine cultures did not reveal reference ranges or normal values for the patient results. 2. Chart review for in- house patient laboratory test reports for the bilirubin results did not reveal reference ranges or normal values for the patient results. 4. During an inteview with the Testing Personnel #1(CMS-209) on March 16, 2023 at the nurses' station, confirmed that the test reports for in-house patient test did not include reference ranges or normal values. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 16, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following Condition level deficiency was cited: D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the Quality Control Documents and staff interview the laboratory failed to monitor and evaluate the overall quality of the Reichert Unistat Bilirubinometer Analyzer for the analyte of Total Bilirubin. Reference: 5447 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. 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 Quality Control (QC) Data, the manufacturer's operation manual, and staff interview, the laboratory failed to perform QC for the Reichert Unistat Bilirubinometer. The findings include: 1. Based on review of the QC data, the laboratory failed to perform QC on the Reichert Unistat Bilirubinometer, from 05/7 /2018, installation date to January 16, 2019. 2. The operation manual for the Reichert Unistat Bilirubinometer states under 7.1 " Use of Commercial Serum Controls, that Analysis of at least a normal and abnormal level of a commercial serum control, assayed for total bilirubin, is recommended for checking performance of the Reichert Unistat Bilirubinometer." Under 7.2 "Quality Control Frequency, QC procedures should be performed before and after each sample run in response to questionable patient results and / or mandated by local regulations." 3. Interview with the Laboratory Director, Practice Administrator, and staff # 2, at 2:45 in the Conference Room on January 16, 2019, confirmed that they were not performing QC on each day of patient testing. It was agreed that they would stop testing until QC material was available. -- 2 of 2 --