Eastman Pediatric Clinic Dba New Life Pediatrics

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on November 19, 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: 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 procedures as described by the manufacturer. THE FINDINGS INCLUDE: 1. A review of the manufacturer's requirements for the Taxo A Disc Throat Culture screen confirmed that 2 levels of quality controls should be run along with each batch of cultures plated. 2. A review of the 2023 - 2025 Quality Control Records revealed that documentation of the required controls were not appropriately performed for the Throat Culture screening procedure. 4. An exit interview, with Laboratory Staff, on November 19, 2025, at 3:00pm, in the breakroom, confirmed that the laboratory failed to perform quality control procedures, as required by the manufacturer, for the Taxo A Disc Throat Culture screen. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; 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: A review of 2023 - 2025 Quality Assurance Records and the 2023 - 2025 Quality Control Records confirmed that the Laboratory Director failed to ensure that the quality control and quality assessment programs were established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Reference D5449 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on November 30, 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: 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: Based on review of the Installation documents for the Sysmex XP-300 Hematology 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 -- Analyzer (Sysmex) and staff interview, the laboratory failed to perform calibration at least every 6 months. Findings: 1. Review of the Installation documents for the Sysmex was calibrated on 9/8/2020 during the install. There were no other documented calibrations for the Sysmex for March 2021, and September 2021. 2. Interview with staff #2 (CMS 209 Personnel Form), on 11/30/2021 at approximately 11 am in the breakroom, confirmed the above aformentioned statement. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: The Laboratory Director (LD) must ensure that the quality assessment(QA) programs are established and maintained to ensure the quality of laboratory services provided and to identify failures in quality as they occur. Findings: 1. Review of the Installation documents for the Sysmex Hematology Analyzer, the Sysmex was calibrated on 9/8 /2020 during the install. There were no other documented calibrations for the Sysmex for March 2021, and September 2021. 2. Interview with staff #2 (CMS 209 Personnel Form), on 11/30/2021 at approximately 11 am in the breakroom, confirmed the above aformentioned statement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on November 6, 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: 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: Based on review of the Medonic M series Hematology Analyzer(Medonic), and staff 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 -- interview, the laboratory failed to perform calibrations every 6 months. Findings: 1. A review of the calibration documents for the Medonic, the laboratory had documentation that calibrations were performed on the following days: 08/09/2019, 09 /28/2018 (11 months), 03/16/2018 ( 6 months) , 08/04/2018 ( 7 months), 02/13/2017 (6 months). 2. Interview with staff #2 (CMS 209 form), on 11/06/2019, at approximately 11:30 am, in the breakroom, confirmed that the calibrations were not performed every six months. -- 2 of 2 --