Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Christine S Rausch MD, PC (laboratory) on 11/14/23 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on tour of the laboratory, review of manufacturer's Safety Data Sheet (SDS), and interviews, the laboratory failed to follow manufacturer's instructions for disposing the StatLab XS-3, Xlyene Substitute reagent utilized to fix Mohs histological samples to examination glass slides at the date of survey on 11/14/23. Findings include: 1. A tour of the laboratory on 11/14/23 at 09:20 AM revealed the laboratory utilizes the StatLab XS-3, Xlyene Substitute reagent to fix Mohs histological samples to examination glass slides for microscopic review. During the tour, the inspector asked the primary testing personnel how they dispose of the xylene substitute reagent. They stated, "we flush the reagent down the sink with copious amounts of water." 2. Review of the SDS for the Xylene substitute reagent revealed the following instructions, "Section 6 Environmental Precautions- Prevent entry to sewers and public waters, Avoid release to the environment. Collect spillage." "Section 13: Disposal Considerations, Waste Disposal Recommendations- Dispose of contents/container in accordance with local, regional, national, territorial, provincial, and international regulations. Ecological- Waste Materials- Avoid release to the environment. This material is hazardous to the aquatic environment. Keep out of sewers and waterways." 3. In an phone interview with the StatLab technical support at 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 -- 09:45 AM on 11/14/23 , they stated, "we do not recommend or support disposing of the XS-Xylene substitute reagent down sinks with water. We encourage sites to dispose of the materials through a biohazard company." 4. An exit interview with the primary testing personnel and lab director on 11/14/23 at 10:45 AM confirmed the findings. -- 2 of 2 --