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 review of American Proficiency Institute (API) 2025 and 2026 proficiency testing records, the laboratory failed to successfully participate in a proficiency testing program approved by CMS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in hematocrit testing (Refer to D2130). D2130 HEMATOLOGY 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 -- 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 desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, review of American Proficiency Institute (API) 2025 and 2026 proficiency records, review of form CMS 116 and email correspondence with the technical consultant (TC) #1, the laboratory failed to achieve satisfactory performance for hematocrit (HCT) in two out of three consecutive testing events. Findings: 1. Review of the CASPER 0155 report showed the following results: Hematology 2025 2nd event the laboratory received an unsatisfactory score of 20 percent for the analyte hematocrit (HCT). Hematology 2026 1st event the laboratory received an unsatisfactory score of 40 percent for the analyte hematocrit (HCT). 2. Review of the American Proficiency Institute (API) 2025 and 2026 proficiency records confirmed the CASPER 0155 report results. 3. Review of form CMS 116 showed the laboratory performs approximately 1129 hematocrit patient tests per year. 4. Email correspondence with the technical consultant (TC) #1, on June 29, 2026, at 3:09 PM confirmed the laboratory failed to achieve satisfactory performance for hematocrit (HCT) in two out of three consecutive testing events. -- 2 of 2 --