Summary:
Summary Statement of Deficiencies D0000 An announced virtual CLIA recertification survey was conducted for Advanced Dermatology of Virginia on August 30, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on July 30, 2021 and virtual record review conducted on August 20, 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 laboratory's policies and procedures, verification of accuracy records and an interview, the laboratory failed to follow their established policy and verify the accuracy of the Potassium Hydroxide (KOH) microscopic examinations at least twice annually in the calendar year 2020. Findings include: 1. Review of the laboratory's policies and procedures revealed a policy, "Verification of PPM Test Results", with a statement, "5. PROCEDURE: PARASITOLOGY and KOH, Twice a year, the testing personnel will select a patient from whom to collect a specimen for competency and proficiency testing. 2. Each testing personnel prepares the sample for testing, reads the slide and records the results on the Bi-annual KOH and/or Scabies Competency and Proficiency Testing for Laboratory Personnel Form...6. The Bi- annual KOH and/or Scabies Competency and Proficiency Testing for Laboratory Personnel Form shall be retained in the Office Location for at least 2 years." 2. Review of the laboratory's verification of accuracy records revealed a lack of documentation of twice annual verification of accuracy for KOH microscopic examinations for calendar year 2020. The surveyor requested to review documentation of the 2020 twice annual verification of accuracy for KOH 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 -- microscopic examinations. The laboratory provided no documentation to review. 3. In an exit interview with the lead Mohs technician on August 31, 2021 at approximately 10:45 AM, the above findings were confirmed. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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 Laboratory Personnel Report Form (CLIA) (CMS-209 Form), laboratory's policies and procedures, testing personnel (TP) records, lack of documentation, and interview, the technical consultant (TC) failed to follow the laboratory's established policy to perform and document the annual competency assessments for three (3) of five (5) TP in calendar year 2020. Findings include: 1. Review of the CMS-209 form revealed there were a total of 5 TP performing patient testing. 2. Review of the TP records revealed lack of documentation by the TC of performance and review of the 2020 annual competency assessments for the following 3 TP: TP C, TP D, TP E. See attached TP code sheet. The surveyor requested to review the 2020 competency assessments for TP C, TP D and TP E. The laboratory provided no documentation to review. 3. Review of the laboratory's policies and procedures revealed a policy, "Competency Assessment for Testing Personnel" with a statement, "5. PROCEDURE: A. Competency Assessment occurs at hire, at six months and then annually and is performed for each test the testing personnel performs..." 4. In an exit interview with the lead Mohs technician on August 30, 2021 at approximately 10:45 AM, the above findings were confirmed. -- 2 of 2 --