Summary:
Summary Statement of Deficiencies D0000 Based on the desk review of proficiency testing (PT) from 2022 through 2025, the laboratory failed to meet the following conditions, resulting in a noninitial unsuccessful PT participation: D2016 - 42 CFR 493.803 Condition: Successful participation (proficiency testing) D6076 - 42 CFR 1441 Condition: Laboratories performing high 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 a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2024 and 2025 records, the laboratory did not successfully 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 -- participate in a proficiency testing 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 specialty of Hematology for the analyte of WBC Diff (White Blood Cell Differential). Refer to 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 a proficiency testing desk review of CASPER 0155 report and American Proficiency Institute (API) Proficiency testing 2024 (Event 3) and 2025 (Event 2) records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two out of three testing events in the specialty of Hematology for the analyte White Blood Cell (WBC) Diff (Differential). Findings include: 1. Review of CASPER 0155 report revealed the following results: Hematology 2024 - 3rd event the laboratory received an unsatisfactory score of 12% for WBC Diff analytes. Hematology 2025 - 2nd event the laboratory received an unsatisfactory score of 60% for WBC Diff analytes. 2. A review of the API proficiency testing records confirmed the laboratory received the above results. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and American Proficiency Institute (API) 2024 and 2025 records, the laboratory director (LD) failed to provide overall management and direction of the laboratory services. The LD failed to ensure the overall quality of the laboratory services provided. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 desk review of CASPER 0155 report and American Proficiency Institute (API) 2024 and 2025 records, the laboratory director (LD) failed to ensure the overall quality of the laboratory services provided. The LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --