Pediatric And Neonatal Specialists

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 04/10/2025. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 direct observation, review of the Sysmex XN-L Series manufacturer's instructions, laboratory environmental records, and confirmed in staff interview, the laboratory failed to ensure relative humidity was monitored daily for 3 of 3 months (04 /2024, 07/2024, 12/2024). Findings include: During a tour of the laboratory area on 04 /10/2025 at 11:10 AM, a Sysmex XN 300 (Serial Number 11800) was observed. Review of the Sysmex XN-L Series Installation Site Requirements (Document No. 1352-MKT, Rev. 3 October 2017) revealed a relative humidity requirement of 20 % to 85%. A random review of the laboratory's environmental records (April 2024, July 2024, December 2024) revealed the laboratory failed to monitor relative humidity in the laboratory area for the following dates: April 2024 - 12,15,16,17,18,19,30 July 2024 - 22,23,24,25,26,29,30 December 2024 - 2,3,4,5,6,7,8,9,10,11,12,13,16,17,18,19,20,23,24,26,27,30,31 In an interview on 04/10 /2025 at 12:45 PM in the conference room, Testing Personnel #1 and Testing 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 -- Personnel #4 confirmed that the relative humidity was not monitored for the days in question. This confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 01/18/2024 and concluded on 01/18/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on document review of facility proficiency test (PT) records and interview, the laboratory failed to ensure the Laboratory Director (LD) and Testing Personnel (TP) signed a proficiency testing attestation statement for two (2) of three (3) proficiency test events reviewed (Events 1 and 2 of 2023). The LD and TP failed to attest the routine incorporation of the American Proficiency Institute (API) proficiency test samples into the patient workload using the facility's routine methods. Findings included: Review of facility documentation revealed the laboratory had no record of signed attestation statements from the LD and TP for Events 1 and 2 of 2023 for hematology. The attestation statement forms for Events 1 and 2 of 2023 were not available for review. During an interview on 01/18/2024 at 11:03 AM, TP #1 stated the laboratory did not have record of signed attestation statements for Events 1 and 2 of 2023 for hematology. D2127 HEMATOLOGY CFR(s): 493.851(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 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 -- score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to return PT results for hematology within the time frame specified by the program, resulting in unsatisfactory performance and a score of 0 for the testing event. Findings included: Review of the laboratory's records for the hematology PT event 2 of 2023 revealed that the results for one or more testing events were not submitted to the American Proficiency Institute (API) within the required time frame. The laboratory's Proficiency Testing Evaluation reports from the API for the relevant period indicated scores of 0% for the affected testing events (Event 2 of 2023), consistent with the program's policy of assigning a score of 0 for late submissions. During an interview on 01/18/2024 at 11:45AM, Testing Personnel (TP) #1 confirmed that there were delays in submitting the PT results for the specified events due to a change in Technical Consultant (TC) at the end of 2022. -- 2 of 2 --