Saltzman Tanis Pittell Levin & Jacobson Inc D/B/A

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Saltzman, Tanis, Pittell, Levin, & Jacobson Inc. dba Pediatric Associates - Boynton Beach on August 12, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on interview, review of American Proficiency Institute Proficiency Testing (PT) records and the procedure manual, the laboratory failed to run proficiency testing samples for hematology in the same manner as it runs patients for three (2024 3rd, 2025 1st, 2nd ) of five (2023 2nd , 3rd, 2024 1st, 2nd, 3rd, 2025 1st, 2nd) events for hematology. Findings: 1. Review of the instrument printouts showed proficiency testing samples were run more than once for samples that did not contain any flagged test results indicating the results were outside the reference range. The laboratory ran the following hematology samples twice that did not meet the criteria for retesting the samples for: 2024 3rd event sample #12, 2025 1st event sample #2, and 2025 2nd event sample #7. 2. Review of the procedure titled, Lab 410 Proficiency Testing read, "PT samples will be tested the same number of times as routine patient specimens, unless there is a technical reason for it which must be documented on the survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- documentation. Do not run PT samples multiple times if patient samples for that test are not routinely run multiple times." 3. Review of the procedure titled, Lab 404 Lab Test Menu, Reference Ranges, Critical Values noted, "A patient's result which falls outside the normal range and classified as critical should first be checked for specimen integrity (clotted, icteric or lipemia), then retested before reporting the results to the physician or nurse. 4. During an interview on 08/12/2025 at 1:30 PM, the Lab Lead acknowledged the samples were run twice. -- 2 of 2 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to receive a score of 80 percent for bacteriology for the first of three testing events of 2018. Findings include: Review of proficiency teting records for the past two years on 01/30/19 revealed that the laboratory had unacceptable scores for two of five proficiency testing samples and received an overall score of 60% for bacteriology for the first testing event of 2018. During an interview with the laboratory manager at 1: 30 p.m. on 01/30/19, she confirmed that they were aware of the unacceptable score and had completed