Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at PEDIATRIC ASSOCIATES on April 17, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2127 HEMATOLOGY CFR(s): 493.851(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review of Proficiency Testing (PT) results and staff interview, the laboratory failed to submit PT results in the specified timeframe for first event of 2025 for the specialty of Hematology. Findings include: Review of first event of American Proficiency Institute (API) Hematology PT records for 2025 revealed that the due date for results submission was 03/26/2025, review of instruments print out revealed that the samples were tested on 03/27/2025, the test list include: Cell Identification or White Blood Differential, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cells and Platelets. During an interview on 04/17/2025 at 12:00 PM, the Lead Technician confirmed that the laboratory failed to submit on time the results for the first event of PT for 2025. 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 --