Foot And Ankle Clinic Of The Virginias

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Foot and Ankle Clinic of the Virginias on 06/08/22 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: 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 the review of proficiency testing (PT) records, lack of documentation and interview, the lab failed to verify the accuracy twice a year for the nail fungus and wound culture panels in 2021. Findings include: 1. Review of available PT records revealed the lab receives at least five blind samples from Thermofisher Scientific to perform verification of accuracy for the nail fungus and wound culture panels assayed on the Biosystems QuantStudio 12 Flex real time PCR system, categorized as non- regulated analytes. In addition, the lab processed and submitted results for accuracy verification of the blind samples on 10/30/21 and 01/04/22. The inspector requested to review additional documentation of the verification of accuracy of the nail fungus and wound culture panels for the calendar year 2021. The documentation was not available for review. 2. An exit interview with the technical supervisor and primary testing personnel on 06/08/22 at noon confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An announced CLIA Initial on-site survey was conducted at the Foot and Ankle Clinic of the Virginias on October 29, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact with laboratory was on September 28, 2020 with off-site record review of documentation beginning on October 15, 2020 and a follow-up phone conference on October 23, 2020. Specific deficiencies cited are as follows: D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report (CLIA) (CMS 209) Form, verification of performance specification records, testing personnel (TP) records, lack of documentation, and interview with the technical supervisor (TS), the TS failed to provide documentation of the initial training and competency assessment for one (1) of 1 TP at the date of survey on October 29, 2020. Findings include: 1. Review of the CLIA CMS 209 Form revealed there was one TP performing patient testing (TP A). See attached TP code sheet. 2. Review of the verification of performance specification records for the QuantStuio 12k Flex Wound and Foot Fungus Polymerase Chain Reaction (PCR) test method revealed the laboratory performed initial verification studies beginning December 17, 2019. The site began testing patients on January 13, 2020. 3. Review of TP A personnel records revealed the lack of documentation of 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 -- initial training and competency assessment. The inspector requested to review the initial training and competency records. The records were not available for review. 4. The TS stated, "The documents are not available for review. It was accidentally deleted from the Dropbox file when we switched lab director" during the exit interview at approximately 10:35 AM on October 29, 2020. -- 2 of 2 --