Summary:
Summary Statement of Deficiencies D0000 A PT Desk Review survey was completed on 1-29-2026. The following condition- level deficiencies were found to be out of compliance: D2016- 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 the proficiency testing desk review (PTDR) of the CASPER report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system and American Proficiency Institute (API) Performance Summary report emailed from SP- 01 (Practice Manager) on 1-28-2026, the laboratory failed to achieve satisfactory performance for two of three testing events in 2025 ( 2nd event = 60% and 3rd event 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 -- = 0%) resulting in unsuccessful participation in the specialty of Hematology for the analyte Red Blood Cell (RBC). Refer to D2131 Legend: SP= Staff Person D2131 HEMATOLOGY CFR(s): 493.851(g) (g) 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 the proficiency testing desk review (PTDR) of the CASPER report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system and API (American Proficiency Institute) Performance Summary report emailed from SP-01 (Practice Manager) on 1-28-2026, the laboratory failed to achieve satisfactory performance for two of three testing events of 2025 (2nd event = 60% and 3rd Event = 0%) resulting in unsuccessful participation in the specialty of Hematology for the analyte, Red Blood Cell (RBC). Findings include: 1. Review of the CASPER report 0155D indicated the following unsuccessful scores for the analyte RBC in the specialty Hematology. a. Event 2-2025: RBC = 60% b. Event 3-2025: RBC = 0% 2. E- mail received on 1-28-2026 at 11:58 am from SP-01, confirmed the unsuccessful scores for analyte RBC on the API proficiency test performance summary for Event 2 (2025 Hematology/ RBC= 60%) and Event 3 (2025 Hematology/RBC 3rd=0%). -- 2 of 2 --