Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey conducted at FM Antonieta Schettino MD PA /dba/ ECC Pediatrics on 11/26/2019, found the facility was not in compliance with 42 CFR Part 493 CLIA requirements. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) results and interview with laboratory director (LD), the laboratory failed to score at least 80 % on Platelets analyte for 1 (3rd event) out of 5 events reviewed in 2018 and 2019. Findings include: Review of American Proficiency Institute PT records for 2018 and 2019, revealed a score of 40 % for Platelets in the 3rd event of 2018. During an interview on 11/26/2019 at 10:30 am, the LD confirmed the failed PT score for the analyte of reference. 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 --