Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 2/4/20 at Saltzman Tanis Pittell Levin & Jacobson Inc, dba Pediatric Associates, a clinical laboratory in Palm Beach Gardens, Florida. The laboratory was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. 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 record review and interview with laboratory personnel, the laboratory did not attain a score of 80 percent on one analyte for the first testing event in 2018. Findings included: Review of proficiency testing records for the past two years revealed that the laboratory received an unsatisfactory score of 60 percent for red blood cell (RBC) count the first testing event of 2018. During an interview with the laboratory supervisor at 11:30 a.m. on 2/4/20, she confirmed that the lsboratory had received an unsatisfactory score on that proficiency testing event. 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 --