Newport Children's Medical Group

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 06/08/2026, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2025-3 and 2026-1), the laboratory failed to successfully participate in a proficiency 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte White Blood Cell (WBC) Count - resulting in unsuccessful performance. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two of three consecutive proficiency events (2025-3 and 2026-1) for the analyte White Blood Cell (WBC) Count: The finding include: WBC Count 60% - 2025 third testing event; WBC Count 60% - 2026 first testing event. A review of the 2025 & 2026 scores from API confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and API records for 2025-3 and 2026-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and API records for 2025-3 and 2026-1 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) (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 the laboratory's proficiency testing (PT) records, and interview with the Technical Consultant (TC) on July 29, 2025, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte for the specialty Hematology in 2024. The findings included: 1. It was the practice of the laboratory to perform moderate complexity testing in the subspecialty of hematology and the laboratory enrolled in the American Proficiency Institute (API) proficiency testing (PT) program for hematology using the Abbott Cell- Dyn -1800 Analyzer. 2. According to the API evaluation report, the laboratory received unsatisfactory scores of 20% in the third event of 2024 for Hematocrit as follows: Sample Reported Result Exp. Result HEM-11 30.8 26.4-29.9 HEM-12 50.5 43.6-49.3 HEM-13 39.5 33.8-38.2 HEM-15 45.3 39.3-44.5 3. On July 29, 2025, at approximately 3:30 pm, the TC confirmed that the laboratory received the above unsatisfactory proficiency scores, with test values exceeding the expected range, indicating a potential systematic error. 4. The laboratory's testing declaration form, signed by the laboratory director on July 24, 2025, stated that the laboratory performed approximately 582 hematology tests annually. D6043 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(5) (b)(5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratorys established performance 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 -- specifications; This STANDARD is not met as evidenced by: Based on the review of the laboratory's monthly Quality Control (QC) chart for Hematocrit and an interview with the Technical Consultant (TC) on July 29, 2025, it was determined that the Technical Consultant did not resolve technical problems or ensure timely remedial actions for deviations in quality control material from the established range. 1. On July 29, 2025, at approximately 3:30 pm, the TC affirmed that QC results for all three QC levels had shifted above the upper limit on the QC chart for the hematocrit analyte from August 2024 to December 2024. 2. The laboratory demonstrated an unsatisfactory proficiency (PT) report for Hematocrit during the period of shifted QC. See D2121. -- 2 of 2 --