Youthcare Pediatrics Of Central Georgia Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on December 17, 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: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: A review of the Laboratory Procedure Manual, manufacturer's BinaxNOW RSV Card Procedure, and manufacturer's HardyDisk Bacitracin Differentiation Disk Procedure confirmed that the facility failed to follow the established procedures and the existing procedure manual did not contain written procedures for all tests, assays, and examinations performed by the facility. THE FINDINGS INCLUDE: 1. A review of the current procedure manual revealed that the required Complete Blood Count Procedure, Down-Time Procedure, and Personnel Procedure were not completed. 2. A review of the Procedure Manual revealed that the laboartory adopted the manufacturer's BinaxNOW RSV Card Procedure and the manufacturer's HardyDisk Bacitracin Differentiation Disk Procedure as their approved procedures of operation. 3. A review of the manufacturer's BinaxNOW RSV Card Procedure confirmed that testing remained waived only when the approved mandates were adhered. The following mandates were found to be noncompliant: a. FDA classified the test as waived complexity for testing of patients under the age of 5 (five) years of age. The laboratory stated that their testing population included patients older than 5 (five) 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 -- years old. b. Additional mandates require that negative test results be confirmed by more complex cell culture or DFA testing procedures. 4. A review of the manufacturer's HardyDisk Bacitracin Differentiation Disk Procedure confirmed the following deviations from the procedure: a. INTENDED USE states that the test is only a screen for Group A Beta Streptococcal. b. LIMITATIONS OF THE PROCEDURE states that more definitive testing is required for a complete identification. c. INTERPRETATION OF RESULTS defines any zone of inhibition beyond the edge of the disk be interpreted as a "PRESUMPTIVE positive identification for Group A Beta strep". d. Facility reported presumptive positive results as positive results. 5. An exit interview, with laboratory staff, on December 17, 2025, at 1:45pm, in the breakroom confirmed that the laboratory failed to follow the established procedures or establish all required procedures per CLIA requirements. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Quality Control Records confirmed that the laboratory failed to perform quality control for moderately complex procedures as required by CLIA Regulation 493.1256(d)(3)(i). THE FINDINGS INCLUDE: 1. A review of the 2023 - 2025 Quality Control Records revealed that controls were not included with the Throat Culture screening procedure. 2. An exit interview, with laboratory staff and Laboratory Director, on December 17, 2025, at 1:30pm, in the breakroom, confirmed that the laboratory failed to perform quality control for procedures as required by the manufacturer and CLIA Regulation 493.1256(d)(3)(i). -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on , 2023.October 20, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Based on review of the Incubator Temperature Log, and staff interview, the Laboratory failed to perform

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on February 11,2022. 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: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: 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 -- Based on calibration document review and staff interview, the lab failed to calibrate the Cell-Dyn Emerald analyzer every six (6) months as required by the manufacturer. Findings include: 1. Review of calibration data revealed the Emerald was calibrated 1 /18/19. There was no documentation of a calibration after that date. The lab failed to calibrate the Emerald, in July/2019, January 2020, July 2020, January 2021, July 2021, and January 2022. 2. Interview with testing personnel #3, (CMS 209 form) and the Laboratory Director, on February 11, 2022 at approximately 12 PM in the Office Manager's office , confirmed the aforementioned statement. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Calibration Documents for the the Emerald Hematology Analyzer (Emerald), and staff interview, the Laboratory Director(LD) failed to provide oversite for the overall operation and administration of the laboratory. Findings: 1. Review of the Emerald Calibration documents, the lab did not perform a calibration on the Emerald every six months from 01/18/2019 to 02/11/2022 as required by the manufacturer. 2. Interview with staff #3 (CMS 209 form), and the LD, on 02/11/2022 at approximately 12:30 in the Office Manager's office confirmed that the Emerald was not calibrated after January 19, 2019. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 8, 2019. 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: D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the Quality Control(QC) documents for the CellDyn Emerald (Emerald) Hematology analyzer, and staff interview, the laboratory failed to monitor the acceptability of the QC, before releasing patient results. Reference D5481 D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 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 -- Based on review of the Quality Control(QC) documents for the CellDyn Emerald (Emerald) Hematology analyzer, and staff interview, the laboratory failed to monitor the acceptability of the QC, before releasing patient results. Findings: 1. Review of the QC documents for the Emerald confirmed during the months of May, October, and November 2018 the following findings: May 7, 2018, all three levels of controls were out of range for the analyte Red Blood Cell(RBC). and 10 patients were resulted May 8, 2018, all three levels of controls were out of range for the analyte RBC, and 17 patients were resulted May 14, 2018, all three levels of controls were out of range for the analyte RBC, and 13 patients were resulted October 19, 2018, all three levels of controls were out of range for the analyte RBC, and 1 patient was resulted November 2, 2018, two levels of controls were out of range for the analyte RBC, and 18 patients were resulted November 8, 2018, all three levels of controls were out of range for the analyte RBC, and 15 patients were resulted 2. Interview with staff #2 (CMS 209 form), on August 8, 2019, at approximately 4pm, in the office, confirmed that the QC was out of range for the aforementioned dates, and patients were resulted. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (E) The laboratory director must-- (E)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on review of the Quality Control(QC) documents for the CellDyn Emerald (Emerald) Hematology analyzer, and staff interview, the Laboratory Director (LD) failed to provide oversight for the accuracy and acceptability of the QC. Findings: 1. Review of the QC documents for the Emerald confirmed that during the months of May, October, and November 2018 the following findings: May 7, 2018, all three levels of controls were out of range for the analyte Red Blood Cell(RBC). and 10 patients were resulted May 8, 2018, all three levels of controls were out of range for the analyte RBC, and 17 patients were resulted May 14, 2018, all three levels of controls were out of range for the analyte RBC, and 13 patients were resulted October 19, 2018, all three levels of controls were out of range for the analyte RBC, and 1 patient was resulted November 2, 2018, two levels of controls were out of range for the analyte RBC, and 18 patients were resulted November 8, 2018, all three levels of controls were out of range for the analyte RBC, and 15 patients were resulted 2. Interview with staff #2 (CMS 209 form), on August 8, 2019, at approximately 4pm, in the office, confirmed that the QC was out of range for the aforementioned dates, and that patients were resulted. -- 2 of 2 --