Dermatology Associates Of Virginia Pc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Dermatology Associates of Virginia on October 16, 2019 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: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the tour of the laboratory, review of policy and procedures (P&P), lack of documentation, and interview with the clinical manager, the laboratory did not follow the written policy for performing daily maintenance on the Nikon microscope (Serial number 1105405) from February 1, 2018 and up to the date of survey on October 16, 2019, a total of twenty-one (21) months and sixteen (16) days. Findings include: 1. Tour of the laboratory at approximately 2:15 PM revealed that the laboratory performs Potassium Hydroxide (KOH), scabies, Tzank smear and histological microscopic examinations using the Nikon microscope (Serial number 1105405). 2. Review of the P&P "Equipment Quality Control Form 1: Microscope Use Protocol" (signed updated as of 2/2018 by the lab director) revealed the following statement: "Microscope stage and ocular eyepieces are to be cleaned every day when used." 3. The inspector requested documentation of the cleaning of the microscope each day of use from February 1, 2018 and up to the date of survey. In an interview with the clinical manager at approximately 3:30 PM, she/he stated that the microscope was cleaned 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 -- each day but they did not document the cleaning. She/he confirmed that there was a lack of documentation of performing the daily maintenance of the above-specified microscope. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Dermatology Associates of Virginia on January 18, 2018 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 the potassium hydroxide (KOH) semi-annual verification records and an interview, the laboratory failed to verify the accuracy twice a year in 2017 for the KOH microscopic examinations. Findings include: 1. The review of the KOH semi-annual verification records for 2016 and 2017 revealed that the laboratory performed the accuracy verification on May 9, 2017. There were no other records available for review for a second verification in 2017. 2. An interview with the practice manager at approximately 11:00 AM confirmed that the laboratory failed to perform the twice a year accuracy verification for the KOH microscopic examinations in 2017. 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 --