Skin Cancer Center Of Northern Virginia

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Skin Cancer Center of Northern Virginia on February 14, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies cited are as follows: D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the laboratory's temperature records, manufacturer requirements, lack of documentation, and interview, the lab failed to monitor and document the room temperatures for eighteen (18) of 18 Mohs surgery days reviewed from November 1, 2021 until November 30, 2021. Findings include: 1. Review of laboratory's temperature log records revealed a lack of documentation of room temperature recordings for the following Mohs surgery days from November 1, 2021 until November 30, 2021: 11/1/2021, 11/2/2021, 11/4/2021, 11/5/2021, 11/8/2021, 11 /9/2021, 11/10/2021, 11/11/2021, 11/12/2021, 11/15/2021, 11/16/2021, 11/17/2021, 11 /18/2021, 11/19/2021, 11/22/2021, 11/23/2021, 11/29/2021 and 11/30/2021. Total of 18 of 18 days reviewed. The surveyor requested to review documentation of the room temperature for the above listed 18 days. The laboratory provided no documentation to review. 2. Review of the Avantik QS 11 Cryostat Product manual revealed the required Operating Temperature of +5C to +35C (+41F to +95F). 3. In an exit interview with the Laboratory Director and Office Manager on February 14, 2023 at approximately 11:00 AM, the above findings 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 2 -- D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, 2021 Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced virtual CLIA recertification survey was conducted for Skin Cancer of Northern Virginia on May 26, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on April 29, 2021 and virtual record review conducted on May 21, 2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is 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), laboratory's policies and procedures, quality assurance documentation, lack of documentation, and interviews, the laboratory failed to perform four (4) of four (4) annual Histopathology accuracy verifications in calendar years 2019 and 2020. Findings include: 1. Review of the laboratory's CMS 116 form revealed the laboratory was performing high complexity Histopathology during the twenty-eight months reviewed (January 2019 to May 2021). 2. Review of the laboratory's policies and procedures revealed a policy, "Frequency and Record of Quality Control Analyses", that stated "Two cases of Mohs surgery will be sent to the outside laboratory per year. These cases will be reviewed, and the results recorded on the appropriate QC form." 3. Review of the laboratory's quality assurance documentation from January 2019 to the date of survey revealed a lack of documentation of the Histopathology two times accuracy verification for calendar years 2019 and 2020. The inspector requested documentation of the two times verification of accuracy for 2019 and 2020. The laboratory provided no additional documentation for review. 4. In an interview with the Mohs Technician on 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 -- May 26, 2021 at approximately 11:05 AM, the Mohs Technician stated they forgot to perform the two times accuracy verification for 2019 and 2020. 5. In an interview with the Laboratory Director on May 26, 2021 at approximately 11:10 AM, the above findings were confirmed. -- 2 of 2 --