Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Rockingham Dermatology on 05/31/22 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: 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 manufacturer package insert, policy and procedures (P&P), daily patient test logs and interview, the lab failed to follow the manufacturer instructions of reading the ACU-DTM (Dermatophyte Test Medium) at 14 days of incubation for 14 of 61 patients reviewed from 11/01/20 up to date of survey on 05/31 /22. Findings include: 1. Review of the ACU-DTM (Dermatophyte Test Medium) manufacturer package insert revealed the following statement, "Results- Color interpretation of test results is questionable after 14 days due to the possibility of false positives." 2. Review of the P&P "Fungal Culture/Dermatophyte Test Medium" that stated, "Test procedure- Examine the culture at the following times- 2 weeks (14 days) for the growth characteristics reported in reading results below." 3. Review of the daily patient test log revealed the following 14 patients recorded as read for results greater than 14 days of incubation: Patient 27288- inoculated on 02/22/21 and recorded as read for results on 03/06/21, 16 days, Patient 27132- inoculated on 03/04 /21 and recorded as read for results on 03/25/21, 21 days, Patient 27718- inoculated on 06/23/21 and recorded as read for results on 07/12/21, 19 days, Patient 27398- 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 -- inoculated on 06/23/21 and recorded as read for results on 07/12/21, 19 days, Patient 27756- inoculated on 06/23/21 and recorded as read for results on 07/12/21, 19 days, Patient 12986- inoculated on 06/24/21 and recorded as read for results on 07/12/21, 18 days, Patient 20955- inoculated on 08/02/21 and recorded as read for results on 08/18 /21, 16 days, Patient 27929- inoculated on 08/02/21 and recorded as read for results on 08/18/21, 16 days, Patient 28253- inoculated on 10/06/21 and recorded as read for results on 10/25/21, 19 days, Patient 13139- inoculated on 10/05/21 and recorded as read for results on 10/25/21, 20 days, Patient 27398- inoculated on 02/08/22 and recorded as read for results on 02/21/22, 19 days, Patient 28699- inoculated on 02/16 /22 and recorded as read for results on 03/09/22, 21 days, Patient 3583- inoculated on 02/28/22 and recorded as read for results on 03/22/22, 22 days and Patient 8285- inoculated on 03/24/22 and recorded as read for results on 04/11/22, 18 days. 4. An exit interview with the office manager and nurse on 05/31/22 at approximately noon confirmed the findings. -- 2 of 2 --