Southern Crescent Pediatrics Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 22, 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 review of the of the laboratory's American Association of Bioanalyst (AAB) proficiency testing (PT) records of 2024 - 2025 found the laboratory did not rotate the analysis of the PT samples among all Testing Personnel. Findings: 1. A review of the PT records revealed only 2 TP (#2 and #3) (CMS 209) were processing the PT samples for submission. 2. A review of the CMS 209 form revealed the laboratory has a total 6 clinical laboratory testing personnel. 3. Interview with TP #2 (CMS 209) on 10/22/25 at 12:24 PM in the break room confirmed the aforementioned findings. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 3 -- Based on review of Profiency Testing (PT) records and staff interview, the laboratory Testing Personnel (TP) and Lab Director (LD) failed to attest that PT samples were analyzed in the same manner as patient specimens. Findings: 1. A review of the PT records for 2024 (events 1, 2, &3) and 2025 (events 1 & 2) revealed the attestation forms were not signed by the LD or TP. 2. An interview with TP #2 (CMS 209) on 10 /22/25 at 12:24 PM in the break room confirmed the aforementioned findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 A recertification survey was performed on September 27, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation during the laboratory tour and testing personnel (TP) interview, the laboratory failed to ensure two identifiers were present on 1 out of 1 urine specimen, during the time of the survey. The Findings include: 1. Observation during the laboratory tour revealed there was 1 out of 1 urine specimen with one identifier (1st name only) on the specimen urine cup. 2. Interview with TP #2 (CMS-209) on September 27, 2023 at 12:38 PM, in the laboratory, confirmed the finding. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) result forms and an interview with testing personnel (TP), the laboratory failed to document

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) survey was completed on May 28,2019. 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: 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 interview, the laboratory failed to include all the required information on the in-house laboratory test reports. Findings include: 1. Review of in-house test reports (#112917 and #092106) revealed the lack of reference range for each component. 2. Interview with the clinical supervisor 5/28/19 in the employee breakroom at approximately 11:33 AM confirmed the lack of aforementioned required information on the test reports. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --