All-Star Pediatrics

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 08/24/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, manual review, and confirmed in interview with Laboratory Director (LD) and Testing Personnel 1 (TP1), the laboratory failed to perform two of the four required verification of performance specifications for an unmodified, FDA- cleared or approved system. Findings include: 1. Observed on 08/24/2023 at 9:15 AM, a Sysmex XP-300 Hematology analyzer was in use for testing. 2. Review of the manual titled "Resource & Validation Manual, Sysmex XP-300 Hematology Analyzer" in Section 3 "Validation Protocols" and "Table of Contents", stated, " It is the customer's responsibility to perform additional studies, following the requirements of their accrediting agencies. The following protocols are provided: "Correlation studies and Reference Range verification." 3. Review of the manual titled "Resource & Validation Manual, Sysmex XP-300 Hematology Analyzer" revealed failure to include verification studies for the following: a. accuracy b. reference intervals. 4. In an interview on 8/24/2023 at 11:25 AM, the LD and TP1 were asked if accuracy and reference interval verification studies had been performed on the XP-300 Hematology 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 -- analyzer. The LD and TP1 stated the accuracy and reference interval verification studies were not performed on the analyzer. This confirmed the findings. -- 2 of 2 --

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 desk review of proficiency testing results from the American Proficiency Institute on 08/17/2018, the laboratory failed to successfully participate in the specialty of Bacteriology in two consecutive 2018 testing events. See D2020 and D2028 D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 -- performance. This STANDARD is not met as evidenced by: Based on desk review of Bacteriology proficiency testing results from American Proficiency Institute on 08/17/2018, the laboratory failed to attain an overall testing score of 80 percent in two consecutive testing events in 2018. Findings include: The laboratory scored 0 percent in the first testing event of 2018 and scored 0 percent in the second testing testing event of 2018 for unsatisfactory performances. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Bacteriology proficiency testing results from American Proficiency Testing agency on 08/17/2018, the laboratory failed to achieve a successful testing performance in the specialty of Bacteriology in the first two testing events of 2018. Findings include: The laboratory had an unsatisfactory performance in the first testing event of 2018 with a score of 0 percent and had an unsatisfactory performance in the second testing event of 2018 with a score of 0 percent for an unsuccessful proficiency testing performance. -- 2 of 2 --