Pediatric Associates Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at PEDIATRIC ASSOCIATES INC from 05/08/2026 to 05/12/2026 . The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited 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 examine or test Proficiency Testing (PT) samples with the laboratory's regular patient workload (testing Personnel (TP)) that routinely perform the testing in the laboratory for four out of four events reviewed for Chemistry specialty. Findings included: 1-Review of FORM CMS-209 signed and dated by the Laboratory Director (LD) on 05/08/2026 revealed the laboratory had six TP listed (TP#1, TP#2, TP#3, TP#4, TP#5 and TP#6). 2-Review of the procedure manual signed by the Laboratory Director (LD) in policy titled, "LAB 410 Proficiency Testing" revealed that stated under "SCOPE" "All laboratory staff are to review and participate in the proficiency program. Any employee who is working in the lab and performing moderate complex patient testing must participate in Proficiency Testing" 3-Review of American Proficiency Institute (API) PT attestation statement records for Chemistry specialty for the following events 2025 (1st, 2nd and 3rd) and 2026 (1st event) revealed that TP#2 failed to sign an attestation in 2025 three events and first event of 2026. 4-During an interview on 05 /08/2026 at 12:20 PM, the Lead Medical Assistant confirmed that TP#2 failed to participate in PT in Chemistry specialty for the events listed above. 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 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 record review and interview, the laboratory failed to receive a passing proficiency test (PT) score for the third testing event of 2017 for the speciality of Hematology. Findings: Review of PT score from American Proficiency Institute for the third event of 2017 showed a scores of 20% for Red Blood Cells and 20% for Hematocrit. During an interview on 7/18/18 at 10:20 AM, Laboratory Manager confirmed the laboratory had failed proficiency testing. 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 --