Summary:
Summary Statement of Deficiencies D0000 . The Southdale Pediatric Associates laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the validation survey performed on September 4, 2025. The following standard-level deficiencies were cited: 493.801 Testing of proficiency testing samples . 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 document review and interview with laboratory personnel, the laboratory failed to ensure Hematology proficiency testing (PT) samples from one of three PT events in 2024 were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory at 10:13 a.m. on 9/4/25. 2. The laboratory performed PT using the Medical Laboratory Evaluation (MLE) proficiency testing provider. 3. The Proficiency Testing Policy found in the Laboratory Policies manual required the laboratory to test PT samples the same number of times that it routinely tests patient specimens. 4. The Specimen Rerun Policy found in the Laboratory Policies manual indicated that Hematology patient specimens are only to be repeated if values are critical or samples are flagged in the comments. 5. Two of Five Hematology PT samples were tested in duplicate for one of three PT events completed in 2024. See below. 2024 MLE 1st event: MX 1 - run twice with no critical values or flags MX 4 - run twice with no critical values or flags 6. In an interview at 1:33 p.m. on 9/4/25, the 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 -- TS confirmed the above findings and indicated the samples would not have required duplicate testing. 7. The 2024 MLE 1st event attestation statement was signed by all testing personnel and the laboratory director. . -- 2 of 2 --