Summary:
Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 5, 2026. At the time of the desk review, it was determined the laboratory was not in compliance with all conditions required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 Code of Federal Regulations, Part 493 (42 C.F.R. 493). The following condition level deficiency was cited: 493.803 Condition: Successful participation. 493. 1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 from the Certification and Survey Provider Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) records, the laboratory did not 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 achieve an overall satisfactory performance (80% or better) for the specialties of Routine Chemistry and Hematology for two out of three proficiency testing events in 2025 and 2026. Refer to D2088 and D2122 D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve an overall satisfactory performance (80% or greater) for the specialty of Routine Chemistry for two out of three proficiency testing events for years 2025 and 2026. Findings included: 1. A review of the CASPER 0155 report revealed the following results: Routine Chemistry 2025-2nd Event, the laboratory received an unsatisfactory score of 0% for overall Routine Chemistry Routine Chemistry 2026-1st Event, the laboratory received an unsatisfactory score of 0% for overall Routine Chemistry 2. A review of the API 2025 Chemistry Core (2nd Event) and API 2026 Chemistry Core (1st Event) proficiency testing records confirmed the laboratory received the above results.. D2122 HEMATOLOGY CFR(s): 493.851(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve an overall satisfactory performance (80% or greater) for the specialty of Hematology for two out of three proficiency testing events for years 2025 and 2026. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2025-2nd Event, the laboratory received an unsatisfactory score of 0% for overall Hematology. Hematology 2026-1st Event, the laboratory received an unsatisfactory score of 0% for overall Hematology. 2. A review of the API 2025 Hematology (2nd Event) and API 2026 Hematology (1st Event) proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing results were returned within the timeframes established by the American Proficiency Institute for the specialties of Routine Chemistry and Hematology for two out of three proficiency testing events for years 2025 and 2026. Refer to D6017. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute proficiency testing records, the laboratory director failed to ensure proficiency testing results were returned within the timeframes established by the American Proficiency Institute. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the specialties of Routine Chemistry and Hematology for two out of three proficiency testing events for years 2025 and 2026. Refer to D2016, D2088 and D2122. -- 3 of 3 --