Mcroberts & Steiner Chartered D/B/A

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 30, 2024. McRoberts and Steiner Chartered DBA Children's Physicians clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on interview, record review of laboratory logs and review of the Beckman Coulter DxH 520 Instructions for Use manual, the laboratory failed to record the humidity of the laboratory from 01/13/2022 to 4/30/2024. Findings: Review of the Beckman Coulter DxH 520 Instructions for Use manual noted a maximum relative humidity rate of 80 %. Review of the laboratory's temperature logs showed the humidity of the laboratory was not recorded. On 04/30/2024 at 11:45 AM, Testing Personnel A acknowledged the humidity of the laboratory was not recorded. 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 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 11/05/2019 at McRoberts & Steiner Chartered dba Children's Physicians, 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 failed to score at least 80 percent on each analyte in two proficiency testing events in the past two years. Findings include: Review of proficiency testing results for the past two years revealed that the laboratory received the following unacceptable scores: 1. 60% for hematocrit on the second testing event of 2019 2. 60% for hemoglobin and red blood cell count on the third testing event of 2017 During an interview with the director of nursing at 12:00 p.m. on 11/05/2019, she confirmed that they had received some unacceptable proficiency testing scores on two events. 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 --