Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at GABLES PEDIATRICS LLC on September 15, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited were as follows: D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory failed to have documentation that the Laboratory Director reviewed and approve the DxH500 Series Complete Blood Counter (CBC) analyzer verification of performance study conducted prior to going live on 01/26/2026. Findings included: 1. Review of the Method Validation for the DxH500 Series CBC analyzer study performed on January 15, 2026, revealed that the study failed to have the acceptance signature of the Laboratory Director. The laboratory tested 606 patients from 01/26/2026 to 09/14/2026. 2. Review of the DxH500 Series Performance Verification Checklist PN C42118AA Appendix D displayed a table header stated "Hematology - To be completed during implementation by laboratory staff. Table D.1 Performance Verification Checklist" ... last item listed "Pathology/Lab Director sign-off and Date Completed" was not signed by the Laboratory Director. 3. During an interview on 09/15/2025 at 11:41 AM, the Laboratory Director confirmed that the laboratory failed to have documentation that the Laboratory Director reviewed and approved the verification of performance study. D5785