Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Dermatology Associates of Virginia on October 17, 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 Olympus (serial number 209019), Nikon Eclipse (serial number 105649) and Nikon Labophot II (serial number 243815) microscopes from February 1, 2018 and up to the date of survey on October 16, 2019, a total of twenty-one (21) months and seventeen (17) days. Findings include: 1. Tour of the laboratory at approximately 9:15 AM revealed that the laboratory performs Potassium Hydroxide (KOH), scabies, Tzank smear and histological microscopic examinations using the Olympus (serial number 209019), Nikon Eclipse (serial number 105649) and Nikon Labophot II (serial number 243815) microscopes. 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 microscopes each day of use from February 1, 2018 and up to the date of survey. In an interview 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 -- with the clinical manager at approximately 10:45 AM, she/he stated that the microscopes were cleaned each day but they did not document the cleanings. She/he confirmed that there was a lack of documentation of performing the daily maintenance of the above-specified microscopes. . -- 2 of 2 --