Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hanover Cardiac ASC LLC dba Virginia Cardiac on July 7, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Hanover Cardiac ASC LLC dba Virginia Cardiac was not in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. Specific deficiencies are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing (PT) records, policies and procedures, and interview, the laboratory failed to retain PT attestation sheets signed by the Laboratory Director (LD) or designee for three (3) of eleven (11) PT events reviewed. Findings include: 1. The laboratory participates in Hematology (HEME) and Chemistry (CHEM) PT modules with American Proficiency Institute (API) as customer number 82401. Review of the laboratory's PT records for the HEME and CHEM 3rd events in 2024, all events in 2025, the 1st events in 2026, and the 2nd 2026 CHEM event (a total of 11 events) revealed a lack of director or designee signature of attestation on the following 3 PT events documentation: 2024 CHEM 3rd event, 2026 HEME 1st event, and 2026 CHEM 2nd event. 2. Review of laboratory's Quality Assurance policy revealed section 15 titled Proficiency Testing includes "attestation statements are signed and retained." 3. In an interview at 12:14 pm on 7/7 /26 with the LD and Technical Consultant, the findings above were confirmed. 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 -- 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 review of laboratory proficiency testing (PT) records, policies and procedures, and interviews, the laboratory failed to document review of PT result evaluations as indicated by Laboratory Director (LD) or designee signature for three (3) of eleven (11) PT events reviewed. Findings include: 1. The laboratory participates in Hematology (HEME) and Chemistry (CHEM) PT modules with American Proficiency Institute (API) as customer number 82401. Review of the laboratory's PT records for the HEME and CHEM 3rd events in 2024, all events in 2025, the 1st events in 2026, and the 2nd 2026 CHEM event (a total of 11 events) revealed a lack of director or designee signature indicating review of results on the following 3 PT events result evaluations: 2024 CHEM 3rd event, 2026 HEME 1st event, and 2026 CHEM 2nd event. 2. Review of laboratory's General Lab policy manual revealed section 12 titled Proficiency Testing includes "Scores below 100% should prompt investigation to identify the cause." The laboratory's Quality Assurance policy section 15 Proficiency Testing includes "scores below 100% investigated with