Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Associates on May 6, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited is as follows: D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on records review and interview, the laboratory reported one patient's (#1) Complete Blood Count (CBC) when two (Level 2 and 3) of three levels (Level 1, 2 , and 3) of controls for Hemoglobin (Hgb) were out of the expected range on 11/01 /2025. Findings: 1. Review of the procedure titled, Lab 430 CBC Moderate Complexity (signed and dated by the Laboratory Director on 01/20/2026) noted, "Patient specimens can be analyzed if two of three controls are within the range for one day. 2. Review of the Monthly QC (Quality Control) Summary Report revealed level 2 and Level 3 were out of range on 11/01/2025 for Hgb. 3. During an interview on 05/06/2026 at 1:20 PM, the Regional Lab Supervisor acknowledged two levels of controls for Hgb were out of range and one patient's hematology results were reported. 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 --