Elite Pediatric And Adolescent Medicine, Llc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report (CLIA) Form (CMS-209), the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and staff interview, the laboratory failed to ensure that testing person (TP) two participated in the Hematology/Coagulation PT (four of four events reviewed) in 2024 and 2025 for the complete blood count with automated differential (CBC w/Diff) analytes. The findings include 1. A review of the CMS-209 completed for the recertification survey on 05/29/2025 revealed three TP that performed CBC w/Diff patient testing. 2. A review of the laboratory's API PT Hematology/Coagulation attestation records revealed TP two had not participated in the 2024 Event One, 2024 Event Two, 2024 Event Three, or 2025 Event One. 3. A telephone interview with the laboratory's technical consultant on 06/03/2025 at 9:22 a.m. confirmed the survey findings. Word Key: CLIA- Clinical Laboratory Improvement Amendments D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- proficiency testing (PT) records and staff interview, the laboratory failed to document review and evaluation for the 2024 Hematology/Coagulation event two (one of four events reviewed) for the complete blood count with automated differential (CBC w /Diff) analytes. The findings include 1. A review of the laboratory's API PT records revealed that the 2024 Event Two performance evaluation (print date 08/16/2024) did not have documentation of review on the survey date (05/29/2025). 2. A telephone interview with the laboratory's technical consultant on 06/03/2025 at 9:22 a.m. confirmed the survey findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, lack of records, and staff interviews, the laboratory failed to document

Summary Statement of Deficiencies 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 a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2022 and 2023 American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two consecutive proficiency testing events, resulting in unsuccessful participation for the white blood count (WBC) analyte. (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 a desk review of the CMS 155 and the laboratory's 2022 and 2023 American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive PT events for the white blood cell count (WBC) analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory WBC scores: 2022 Event three 0% 2023 Event one 60% 2. Review of the 2022 event three PT evaluation report revealed a score of 0% for failure to participate. 3. Review of the 2023 event one PT evaluation report revealed an overall score of 60% for the WBC analyte. -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory quality assessment (QA) plan, the 2017 proficiency testing (PT) records, the 2017 and 2018 QA records and interview with the lead testing personnel, the laboratory failed to follow the QA plan in 2017 and 2018. The findings include: 1) Review of the laboratory QA plan revealed the following: "Proficiency Testing Evaluations. ... The accuracy test results are reviewed and retained for a period of at least two years. ... Record Retention. ...All monthly QC reviews are performed by the Technical Consultant or Laboratory Director and include initials or signatures to verify the review. ...Elite Pediatric and Adolescent Laboratory Checklist of Review. ... Elite Pediatric and Adolescent Medicine Monthly Quality Assessment Checklist". 2) Review of the 2017 PT records revealed the 2017 event one comparative evaluation form and performance summary were missing; the 2017 event two comparative evaluation report was missing. 3) Review of the 2017 and 2018 QA records revealed the Elite Pediatric and Adolescent Laboratory Checklist of Review form and the Elite Pediatric and Adolescent Medicine Monthly Quality Assessment Checklist form was missing for January 2017 to present survey date February 19, 2019. 4) Interview on February 19, 2019 at 11:40 a.m. with the lead testing personnel confirmed the 2017 PT records were not available for review and that the Checklist of Review form and the Monthly QA Checklist were not in use for documenting the monthly QA processes from January 2017 to present survey date. 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 --