Dermatology Plc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Dermatology PLC on 08/24/23 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: 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 the review of daily patient test log, manufacturer's instructions for use, patient medical note, lack of documentation, and interview, the laboratory failed to follow manufacturer's instructions for culture incubation time for one of two patient fungal culture results performed in 2022. Findings include: 1. Review of the daily patient test logs revealed two dermatophyte cultures performed on two patients in the 2022. Patient #1 collection and inoculation date on 01/31/22 and a "Date Read" on 05 /25/22. 115 days between date of inoculation and date of reading the culture for results. 2. Review of the manufacturer's instructions for use for the Accuderm AcuDTM Dermatophyte test medium revealed the following statement, "Reading should be made within fourteen days. Interpretation of the test is questionable after fourteen days due to the possibility of false positives". 3. Review of the patients' medical notes in the Modernizing Medicine electronic health record revealed a note of the DTM culture read on 04/20/22 and lacked documentation of a reading of the DTM culture at the required 14-day incubation time period. 4. In an interview with the office manager and primary nurse on 08/24/23 at 10:15 AM, the office manager stated 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 -- that they "felt the culture was read at the 14-day incubation time period but the reviewing clinician failed to record the finding." 5. In an exit interview with the same staff at 10:25 AM the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Dermatology, PLC on May 23, 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: 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 tour of testing area, policy and procedure (P&P) review, manufacturer's package insert (PI) and phone conference with manufacturer, patient test log and interview with testing physician and office manager, the laboratory failed to follow manufacturer's instructions for incubation timeframe of the Dermatophyte Test Medium (DTM) for one (1) of 1 patient on the date of survey on May 23, 2019. Findings include: 1. Tour of the testing area for the DTM culture revealed 1 patient sample (patient 1) incubating at room temperature. The collection date on the vial was April 10, 2019. The inspector requested to review results for patient 1 in the Modernizing Medicine electronic medical records. There was no result for patient 1. 2. Review of the P&P revealed the following statements (approved by the lab director on 8/25/2015): "Dermatology PLC Laboratory Manual" III. Dermatophyte Culture- E. Interpretation of Results- A failure to recover mycelial growth and appropriate color change by two weeks is generally considered a negative test result." 3. Review of the Acu-Derm PI and call to the manufacturer at approximately 10:47 AM revealed that the incubation timeframe is 14 days after inoculation. Color change can be assessed 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 -- from as early as 24 hours and up to 14 days. "Interpretation of test is questionable after 14 days due to the possibility of false positives". The representative from Acu- Derm stated: "we will not support any interpretation of fungal readings after 14 days." 4. An interview with the testing physician and office manager at approximately 11:15 AM confirmed that patient 1 sample exceeded the manufacturer defined 14 days incubation timeframe, inoculated on April 10, 2019 and no interpretation of color change or growth at the date of survey (43 days of incubation). -- 2 of 2 --