Duke Lightner Dermatology

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of laboratory records, review of patient testing logs and interview with laboratory director (LD) 5/12/22, the laboratory failed to establish and/or maintain verification of accuracy for the Dermatophyte Test Medium (DTM) testing, the Potassium hydroxide (KOH)/Wet Prep testing and the Tzanck stain testing since time of last survey, 2/14/19. A period of approximately 3 years and 3 months in which verifications of accuracy were not performed. 4 DTM tests, 4 KOH/Wet tests and 3 Tzanck stains were performed since February of 2019. Findings: 1. The laboratory failed to establish a verification of accuracy procedure for the DTM testing performed and failed to perform a verification of accuracy for the DTM test since time of last survey, 2/14/19. Review of laboratory procedures revealed no procedure for the verification of accuracy for the DTM testing performed. Review of laboratory records revealed no documentation of a verification of accuracy for the DTM test. Review of patient testing logs for DTM revealed 4 patients were tested. Interview with LD at approximately 10:50 a.m. confirmed the laboratory did not perform a verification of accuracy for the DTM test and the laboratory has no procedure for the verification of accuracy for the DTM test. She also confirmed 4 DTM tests were performed since time of last survey. 2. The laboratory failed to perform a verification of accuracy for the KOH/Wet Prep test since time of last survey, 2/14/19. Review of laboratory procedure "PEER SUPERVISED CLIA PROFICIENCY TESTING: KOH" revealed "...Duke is in the process of setting up Quality Control Testing for this procedure. The test will be taken twice a year....". Review of laboratory records revealed no documentation of "test" for the verification 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 -- of accuracy of the DTM test. Review of patient testing logs for the KOH/Wet Prep revealed 4 patients were tested. Interview with LD at approximately 10:50 a.m. confirmed the laboratory did not perform a verification of accuracy for the KOH/Wet Prep test. She stated, due to COVID, Duke never set up the process as intended and she needed to get in touch with them as to the status. She also confirmed 4 KOH/Wet Preps were performed since time of last survey. 3. The laboratory failed to perform a verification of accuracy for the Tzanck stain since time of last survey, 2/14/19. Review of laboratory procedure "PEER SUPERVISED CLIA PROFICIENCY TESTING: TZANCK PREP" revealed "...a viral culture swab will be obtained from the same area of the skin. This will be sent to LabCorp in viral culture media for confirmation of Tzanck preps taken.". Review of laboratory records revealed no documentation of viral culture swabs sent to LabCorp and the corelation with the Tzanck stain. Review of patient testing logs for the Tzanck stain revealed 3 patients were tested. Interview with LD at approximately 10:50 a.m. confirmed the laboratory did not perform a verification of accuracy for the Tzanck stain. She also confirmed 3 Tzanck stains were performed since time of last survey, 2/14/19. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of random patient test reports and interview with office staff 5/12/22, the patient test report failed to include the correct address of the laboratory. Findings: Review of random patient test reports, MR# PH5601 and MR# D3088324, revealed the laboratory address as 82 Wheaton Dr., Youngsville, NC 27596. The address where testing was performed is 11081 Forest Pines Drive, Suite 110, Raleigh, NC 27614. Interview with office staff at approximately 11:00 a.m. confirmed the laboratory address on the patient test reports were incorrect. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of manufacturer's instructions, laboratory procedure, records review and interview with testing personnel (TP), the director, on 2/14/19, the laboratory failed to follow the manufacturer's instructions for reading the results of the ACU- DTM (Dermatophyte Test Medium). Findings: The laboratory uses ACU-DTM for for the performance of fungal cultures. Review of the manufacturer's instructions for reading cultures, it reads under, "...Results The test medium may be examined for color change from yellow to red after 24 hours. Most pathogenic dermatophyte will produce full change in 3-7 days. The medium should be observed frequently during this period to determine that the color change is concurrent with colony growth. Certain non-dermatophytes may on occasion, turn the medium red, but usually only after full colony growth. Color interpretation of test is questionable after 14 days due to the possibility of false positives...". The review of the laboratory procedure entitled Fungal Culture/Dermatophyte Test Medium (DTM), it reads under "...Test Procedure 3. Examine the culture daily during the week for the growth characteristics reported in Reading Results below. All cultures are read by two weeks...". The review of the laboratory's Test Requisition and Report Log revealed testing readings beyond the manufacturer's instructions and laboratory procedure. Findings: a. D1200195: Specimen collected and planted on 5/2/17, and read on 5/24/17. The number of days elapsed was 22. b. XT7285: Specimen collected and planted on 5/18/17, and read on 6 /12/17. The number of days elapsed was 25. c. BT9206: Specimen collected and planted on 6/26/17, and read on 7/24/17. The number of days elapsed was 28. d. 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 -- D1221016: Specimen collected and planted on 7/11/17, and read on 8/1/17. The number of days elapsed was 31. e. G31821: Specimen collected and planted on 11/8 /18, and read on 11/28/18. The number of days elapsed was 20. The results of test read were negative. During interview with the TP, the director, at 11:30 a.m., it was revealed that the provides frequently overlook the DTM cultures, and they are placed in a secluded area of the practice, which contributes to the extended incubation period. However, even with the extended incubation period, all results were negative with no false positives. -- 2 of 2 --