Summary:
Summary Statement of Deficiencies D0000 A Proficiency Testing Desk Review survey was completed on 7/13/26. The following condition-level deficiency was 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 a proficiency testing desk review (PTDR) of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D and College of American Pathologists (CAP) proficiency testing records, indicated the laboratory failed to successfully participate in a proficiency testing program approved by HHS (Health and Human Services), for each specialty, subspecialty, and analyte or test in which the 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 -- laboratory is certified under CLIA (Clinical Laboratory Improvement Amendments). The laboratory failed to successfully participate in the specialty of Chemistry and Subspecialty/Routine Chemistry for the analyte, Ferritin. The laboratory also failed to participate in the Subspecialty of Endocrinology for analytes; Vitamin B12 and CA- 125 (Cancer Antigen 125). Refer to D2096 and D2107. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 a PTDR of the CASPER Report 0155D report and CAP records for Event 3 /2025 and Event 1/2026, the laboratory failed two consecutive testing events for the analyte Ferritin in the subspecialty of Routine Chemistry. Findings include: 1. A review of the CASPER Report 0155D report indicated the following: Chemistry 2025 /Event 3=0% for Ferritin. Chemistry 2026/Event 1=0% for Ferritin. 2. CAP proficiency testing records received via email from SP-4 (CAP Representative) on 7 /13/26 at 11:05 am, confirmed 0% scoring for Ferritin for Events 3/2025 and 1/2026. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 a PTDR of the CASPER Report 0155D and CAP records for Event 3/2025 and Event 1/2026, the laboratory failed two consecutive testing events for analytes CA-125 (Cancer Antigen-125) and Vitamin B12 in the subspecialty of Endocrinology. Findings include: 1. A review of the CASPER Report 0155D indicated the following: Chemistry 2025/Event 3=0% for CA-125 and Vitamin B12. Chemistry 2026/Event 1=0% for CA-125 and Vitamin B12. 2. CAP proficiency testing records received via email from SP-4 (CAP Representative) on 7/13/26 at 11:05 am, confirmed 0% scoring for CA-125 and Vitamin B12 for Events 3/2025 and 1/2026. -- 2 of 2 --