Summary:
Summary Statement of Deficiencies 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 (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and College of American Pathologists (CAP) 2024 and 2025 proficiency records and phone interview with the laboratory manager on May 5, 2025 at 11:25 AM, the laboratory failed to successfully 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 routine chemistry for the analyte glucose, non-waived. Refer to D2096. 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 -- 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 desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, review of College of American Pathologists (CAP) 2024 and 2025 proficiency records and phone interview with the laboratory manager on May 5, 2025, at 11:25 AM, the laboratory failed to achieve satisfactory performance for glucose, non-waived in two out of three consecutive testing events. Findings: 1. Review of the CASPER 0155 report showed the following results: Routine chemistry 2024 2nd event the laboratory received an unsatisfactory score of 40 percent for the analyte glucose, non-waived. Routine chemistry 2025 1st event the laboratory received an unsatisfactory score of 20 percent for the analyte glucose, non-waived. 2. Review of the College of American Pathologists (CAP) 2024 and 2025 proficiency records confirmed the CASPER 0155 report results. 3. Phone interview with the laboratory manager on May 5, 2025 at 11: 25 AM confirmed the laboratory failed to achieve satisfactory performance for glucose, non-waived in two out of three consecutive testing events. -- 2 of 2 --