Summary:
Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on September 18, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6076 - 42 C.F.R. 493.1441 Condition: Laboratory Director, high complexity 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 Enhanced Reporting (CASPER) 155 report and the API-American Proficiency Institute, the laboratory failed to successfully participate in two out of three consecutive testing events for the regulated 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 -- analytes, White Blood Cell (WBC) Differential and Activated Partial Thromboplastin Time (APTT), in 2025, resulting in an initial unsuccessful performance. Refer to D2130. 1. The laboratory's PT performance was unsatisfactory for the first event of 2025 as indicated below: - WBC Differential - 16% -APTT -20% 2. The laboratory's PT performance was unsatisfactory for the second event of 2025 as indicated below: - WBC Differential - 16% -APTT -40% 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 CASPER 155 report and American Proficiency Institute (API) PT records from 2025, the laboratory failed to achieve satisfactory performance (80%) for two of three consecutive testing events for the regulated analytes, White Blood Cell (WBC) Differential and Activated Partial Thromboplastin Time (APTT). Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2025 event 1, WBC Differential 16% 2025 event 1, APTT 20% 2025 event 2, WBC Differential 16% 2025 event 2, APTT 40% 2. A review of the proficiency testing scores from API (2025) confirmed the above findings. 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 the CASPER-0155 Individual Laboratory Report and American Proficiency Institute (API) 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. 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 testing desk review of the CASPER-0155 and American Proficiency Institute (API) 2025-1 and 2025-2, evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. -- 2 of 2 --