Pediatric Associates

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PEDIATRIC ASSOCIATES on June 29, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency 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 (1st, 2nd, 3rd in 2025 and 1st, 2nd in 2026) out of six events reviewed from 2024 (3rd), 2025 (1st, 2nd, 3rd) and 2026 (1st, 2nd). Findings included: 1- Review of form CMS-209 signed and dated by the Laboratory Director (LD) on 06/29/2026 revealed that the laboratory had two Testing Personnel (TP-A, TP-B) listed. 2- Review of personnel files revealed that TP-A, TP-B were TP in 2025 and 2026. 3- Review of American Proficiency Institute (API)- PT records for Chemistry 1st, 2nd, 3rd in 2025, and 1st, 2nd in 2026 revealed that TP-A performed all five events. 4- Review of the policy LAB 410 Proficiency Testing effective on 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)." 5- During interview on 06/29/2026 at approximately 12:45 PM, the Laboratory Lead confirmed that the laboratory failed to have all testing personnel rotate for Chemistry in 2025 and 2026. 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 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to receive a passing proficiency test (PT) score for the third testing event of 2017 for the specialty of Hematology. Findings: Review of PT score from American Proficiency Institute for the third event of 2017 showed a score of 73% for White Blood Cells (WBC) Differential. During an interview on 8/20/18 at 1:50 PM, the Laboratory Manager confirmed the laboratory had failed proficiency testing for WBC differential. 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 --