Pediatric Associates

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PEDIATRIC ASSOCIATES from December 18, 2025 to January 12, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: 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 record review and staff interview, the Laboratory failed to have all testing personnel (TP) rotate through the testing of Proficiency Testing (PT) in the Specialty of Chemistry for five out of five events reviewed 2024 (2nd, 3rd) and 2025 (1st, 2nd, 3rd). Findings included: 1- Review of form CMS-209 signed and dated by the Laboratory Director (LD) on 01/08/2026 revealed that the laboratory had nine Testing Personnel (TP1, TP2, TP3, TP4, TP5, TP6, TP7, TP8, and TP9) listed. 2- Review of personnel files revealed that TP1, TP2, TP3, TP4, TP6 and TP7 were TP in 2024 and 2025. TP5, TP8 and TP9 were TP in 2024. 3- Review of the policy LAB 410 Proficiency testing effective date 05/05/2024 stated "Analytical Phase - All Laboratory testing personnel will rotate testing events equally, using the API test schedule table (including part time personnel)." 4- Review of American Proficiency Institute (API) PT records for Chemistry (2nd and 3rd) 2024 and (1st, 2nd, and 3rd) 2025 revealed that TP1 performed all five events. 5- During interview on 01/08/2026 at approximately 12:10 PM, the Laboratory Lead confirmed that the laboratory failed to rotate Testing Personnel for Chemistry in 2024 and 2025. 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 --

Summary Statement of Deficiencies D0000 An initial certification survey conducted at PEDIATRIC ASSOCIATES on 08/24 /2022 found the clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and staff interview, the laboratory failed to receive a passing score for the second event of 2022 for the specialty of Hematology. Findings include: Review of American Proficiency Institute (API) PT Performance Summary revealed unsatisfactory scores for the Center for Medicare & Medicaid Services (CMS) reportable analytes of White Blood Cell Differential 20%, Erythrocyte Count 20%, Hematocrit 0%, Hemoglobin 0%, Leucocyte Count 20% and Platelet Count 0% resulting in an overall score of 7% for the specialty of Hematology in the second event of 2022. During an interview on 08/24/2022 at 01:30 PM, the Area Supervisor confirmed the proficiency testing failure. 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 --