Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PEDIATRIC ASSOCIATES on May 14, 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 four (1st, 2nd, 3rd in 2025 and 1st in 2026) out of six events reviewed from 2024 (2nd, 3rd), 2025 (1st, 2nd, 3rd) and 2026 (1st). Findings included: 1- Review of form CMS-209 signed and dated by the Laboratory Director (LD) on 05/14/2026 revealed that the laboratory had six Testing Personnel (TP-A, TP- B, TP-C, TP-D, TP-E, TP-F) listed. 2- Review of personnel files revealed that TP-A, TP-B, TP-C, TP-D, TP-E were TP in 2025 and 2026. 3- Review of the policy LAB 410 Proficiency testing effective ate 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 1st, 2nd, and 3rd in 2025 and 1st in 2026 revealed that TP-A performed all five events. 5- During interview on 05/14/2026 at approximately 2:45 PM, the Laboratory Lead confirmed that the laboratory failed to have all testing personnel rotate for Chemistry in 2025 and 1st event in 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 --