Summary:
Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the conditions of the CLIA program. The following condition level deficiencies were found to be out of compliance: 42 C.F.R. 493.803 Condition: Successful Participation [proficiency testing]; 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 routine desk review of the CMS-155 report for proficiency testing performance and review of proficiency testing evaluation reports from the proficiency 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 -- testing provider, American Proficiency Institute, the laboratory failed to achieve satisfactory performance scores for two out of three events in the American Proficiency Institute proficiency testing for the analyte: White Blood Cell differential, in event 1 and event 3 in 2024, 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 a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance, and review of PT evaluation reports from the PT provider, American Proficiency Institute (API), the laboratory failed to achieve a satisfactory score for two out of three PT events for the analyte: White Blood Cell (WBC) differential, for event 1 and event 3 in 2024. Findings include: 1. A review of the CMS-155 report for PT performance on February 6, 2025, at 1:58 PM, revealed the API PT results for the analyte: WBC differential, was 28% for event 1, and 68% for event 3 in 2024. 2. A review of the PT evaluation reports from the PT provider, API, on February 7, 2025, at 11:43 AM, confirmed that the laboratory failed to achieve satisfactory PT scores for two out of three events for the following analyte: WBC differential, for event 1 and event 3 in 2024. -- 2 of 2 --