Wmg Urgent Care Acworth Health Park

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) initial survey was completed on December 16, 2025 - December 16, 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: D5807 TEST REPORT CFR(s): 493.1291(d) (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 interview, facility document review, and facility policy review, the facility failed to ensure that reference ranges for creatinine on a chemistry profile patient report were in agreement with a facility Standard Operating Procedure (SOP) and/or instrument/test manufacturer Instructions for Use (IFU) for 3 of 3 male patient reports and 3 of 3 female patient reports reviewed. Findings included: An Abbott Diagnostics manufacturer IFU titled, "iSTAT CHEM8+ Cartridge," revised 10/15/2021, revealed the section titled, "EXPECTED VALUES," which specified the reference ranges for creatinine were "0.6 - 1.3" milligrams (mg)/deciliter (dl). Further review revealed the sex was not specified. A facility policy titled, "Abbott iSTAT 1 System Chem8+ (Non- Waived)," published 07/16/2025, revealed the section titled, "VII REPORTING RESULTS," which specified the reference ranges for creatinine were "Female: 0.5 - 0.9 [mg/dl]" and "Male: 0.7 - 1.2 [mg/dl]." Final chemistry profile patient reports for 3 of 3 male patients and 3 of 3 female patients reviewed revealed reference ranges for creatinine were "0.44 - 1.03 mg/dl." Further review revealed the sex was not specified. During an interview on 12/16/2025 at 12:30 PM, the Laboratory Director confirmed the discrepant creatinine reference range values between the final patient test reports and the facility SOP and manufacturer IFU for the Chem8+ test cartridge and was 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 -- unable to explain the source of the creatinine reference range values in the facility iSTAT Chem8+ SOP, or on the final patient test reports provided and reviewed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 22, 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: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on document review and staff interview, the laboratory failed to ensure the ACT Diff II can obtain performance specifications comparable to those established by the manufacturer for Accuracy, Precision, Reportable range of test results, and reference intervals. Findings include: 1. Review of ACT Diff II quality control, calibration, and maintenance documents reveals the analyzer was installed November 2020. No validation documents were available at the time of survey. 2. Interview with the Quality Improvement Coordinator on 7/22/21 in the facility manager's office at approximately 12:30 p.m. confirmed the lack of the validation documents. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures 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 -- that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on ACT Diff II quality control (QC) document review and staff interview, the lab failed to monitor over time the accuracy and precision of test performance. Findings include: 1. Review of QC documents reveals the lack of long term QC monitoring (Levey-Jennings charts) from November 2020 to July 2021. 2. Interview with the Quality Improvement Coordinator on 7/22/21 at approximately 11:00 AM in the facility manager's office, confirmed the lack of a long term QC monitoring system. D5785

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 20, 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: D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of Hematology calibration documents and an interview the Technical Consultant Testing Personnel (TP#2 CMS 209), the laboratory failed to perform calibrations on the Coulter AcT Diff 11 CBC Hematology analyzer at least once every 6 months in 2017 and 2018. Findings include: 1. A review of hematology calibration records revealed calibrations were not performed in March 2017 as data dictated. 2. Calibration was performed only once in 2017( 9/24/2017). In 2018, Calibrations were performed 02/18/2018 and 06/26/2018 ( a four(4) months gap) and on 02/08/2019 (a eight(8) months gap). If the manufacturer's reccommendations were followed, calibrations should have been performed in March 2017 and August 2018. 3. An interview with the Technical Consultant TP #2 (CMS 209) at approximately 12:05 pm 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 -- on 2/20/19 in the break room confirmed Hematology calibrations was not performed within six(6) months in 2017 and 2018. -- 2 of 2 --