Snellville Pediatrics

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 12, 2026. 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: D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on the review of the standard operators procedure manual (SOP), American Association of Bioanalylst (AAB) proficiency testing (PT) records, and staff interview, the laboratory failed to follow the SOP to analyze each PT sample the same as patient samples. Findings: 1. Review of the SOP procedure labeled "Quality Assurance Program" section labeled "Proficiency Testing" states "PT samples are tested and ran consistantly as patient specimens for our Complete Blood Count (CBC) test." 2. Review of the AAB PT records for 2025 Events 1, 2, &3 and 2026 Events 1&2 revealed the samples were ran multiple times on multiple days by each testing personnel. 3. Interview with TP #1 (CMS 209 form) on 8/12/26 at 12:22 PM in the breakroom confirmed the findings above. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 testing personnel (TP) documents and staff interview , the technical consultant failed to perform semiannual competency on all testing personnel. Findings: 1. Review of TP competency documents revealed the lack of semi-annual competency on 2 of 9 TP (CMS 209) ; TP #8 & TP #9 did not have the semi annual competencies. 2. Interview with TP #1 (CMS 209) on 8/12/26 at 12:02 PM in the breakroom confirmed the finding above. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of testing personnel(TP) documents and staff interview , the technical consultant failed to perform annual competency on all testing personnel. Findings: 1. Review of TP competency documents revealed 7 of 9 TP (CMS 209) failed to have annual competency performed for the year of 2025. 2. Interview with TP #1 (CMS 209) on 8/12/26 at 12:02 PM in the breakroom confirmed the finding above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 25, 2020. 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: 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 testing personnel (TP) document review and staff interview, the laboratory director/technical consultant (LD/TC) failed to delegate TC responsibilities to qualified TP as required. Findings include: 1. TP competency document review revealed the 2019 initial competencies for Staff #9 (CMS 209) and Staff #11 (CMS 209) were performed by unqualified TP due to lack of educational qualifications. 2. An interview with the lead medical assistant in a medical office on 2/25/2020 at approximately 4:00 p.m. confirmed the aforementioned initial competencies were performed by unqualified TP. 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 --