Summary:
Summary Statement of Deficiencies D0000 An announced off-site CLIA recertification survey was conducted for Skin and Laser Surgery Center on May 6, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on April 7, 2021 and virtual record review conducted on April 29, 2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form (CMS 116), the laboratory's policy and procedures, peer review documentation, lack of documentation, and interviews, the laboratory failed to perform one (1) of two (2) annual Histopathology peer review in calendar year 2020. Findings include: 1. Review of the laboratory's CMS 116 form revealed one testing personnel (TP A) was identified as performing high complexity Histopathology during the twenty-eight months reviewed (January 2019 to April 2021). 2. Review of the laboratory's policies and procedures revealed a policy, "Test Comparison/Peer Review" which stated "Peer reviews are done yearly (at least two) to review slide interpretation with an independent laboratory. Document agreement or disagreement and