Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Oracle Heart & Vascular, Inc on April 22, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Oracle Heart & Vascular, Inc was not in compliance with applicable Standards and Conditions under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Conditions: D5400 - 42 CFR 493.1250 Condition: Analytic Systems D6000 - 42 CFR 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to follow their established PT policy to retain the PT agency's submission forms for four (4) of four Chemistry PT events from November 2024 through the date of the survey on April 22, 2026. The findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT documentation from November 2024 through the date of the survey on April 22, 2026, revealed signed attestation statements and instrument printouts for 2025 API Chemistry Core Events 1, 2, 3 and 2026 API Chemistry Core Event 1. Further review of the laboratory's PT records revealed a lack of result submission Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- forms for the PT events listed above. The surveyor requested to review the documentation listed above. The laboratory provided no documentation for review. 2. Review of the laboratory's policy and procedure manual revealed a policy, "XII. Proficiency Testing", with the statement, "B. Once test results are obtained, the results must be submitted to the proficiency agency within the allotted time. The preferred method is by online submission of results, but results may be mailed or faxed. Copies must be kept of the reports, and the attestation statement must be signed by the person (s) performing the tests." 3. In an exit interview with the Clinical Manager on April 22, 2026, at 11:05 AM, the above findings were confirmed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to follow their established policy to retain and review PT evaluations for four of four Chemistry PT events from November 2024 through the date of the survey on April 22, 2026. The findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT documentation from November 2024 through the date of the survey on April 22, 2026, revealed signed attestation statements and instrument printouts for 2025 API Chemistry Core Events 1, 2, 3 and 2026 API Chemistry Core Event 1. Further review of the laboratory's PT records revealed a lack of PT evaluation forms and documentation of the review of results for the PT events listed above. The surveyor requested to review the documentation listed above. The laboratory provided no documentation for review. 2. Review of the laboratory's policy and procedure manual revealed the "Laboratory Director Requirements" with the statement, "The laboratory director must- ...D. Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that -- ...c. All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require