Hickory Dermatology

Summary Statement of Deficiencies D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of 2021, 2022, 2023, and 2024 quality control records, and interview with histotechnician #1 on 6/4/24, the laboratory failed to document the negative control for the Mart-1 immunohistochemical stain during a three-year period from 5/18/21-6/3/24. Approximately 729 patients were tested during this time. Findings: Review of the manufacturer's product insert for the Bio SB Mart-1/Melan-A antibody used to perform the Mart-1 immunohistochemical stain procedure revealed "... Product Limitations Due to inherent variability present in immunohistochemical procedures (including fixation of tissues, dilution factor of antibody, retrieval method utilized, and incubation time), optimal performance should be established through the use of positive and negative controls. ..." Review of 2021, 2022, 2023, and 2024 quality control records revealed the laboratory documented positive and negative controls for the Mart-1 stain from 4/22/21 (the date of the previous survey) to 5/13/21. On 5/18 /21, the laboratory began using a different form to record quality control. The new form did not include a place to document results for the negative control, and only the positive control was documented. Approximately 729 patients were tested 5/18/21-6/3 /24 when the negative control was not documented. During interview at approximately 2:30 p.m., the histotechnician confirmed that the current "Immuno Checklist and QC" form does not have a place to document the Mart-1 negative control. 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 --

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, review of quality control records, and interview with the Histology Technician 4/22/21, the laboratory failed to document quality control each day of use for the H&E(Hematoxylin and Eosin) stain. Findings: The laboratory's Histopathology-Mohs surgery procedure states, "Frequency and Record of Quality Control Analysis.. Each day that this procedure is performed, the Mohs surgeon checks the first slide of the day to make sure that the Hematoxylin and eosin stain is adequate. They will receive a quality form to fill out each day..." Review of quality control records revealed the Mohs Surgeon failed to document that the H&E stain was adequate each day the procedure was performed for approximately 22 days in March 2020. At approximately 2pm 4/22/21, the Histology Technician confirmed the Mohs Surgeon failed to document for the H& E stain each day of use in March 2020. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory's procedures, review of patient and quality control records, and interview with the Histology technician 4/22/21, the laboratory failed to document the positive and negative control reactivity for the immunohistochemical stain each time of use. Findings: Review of the laboratory's Histopathology- Mohs Surgery procedure and interview with the Histology technician on 4/22/21 revealed the laboratory performs the Mart-1/Melan-A immunohistochemical stain procedure. The laboratory completes an "Immuno Checklist and QC" record and the Mohs surgeon checks and documents for the positive and negative control and stain quality for each patient that has the immunohistochemical stain procedure performed. Review of random "Immuno Checklist and QC" records revealed the positive and negative control reactivity of the immunohistochemical stain was not documented for the following: a. # 376291 on 8/21/19; b. # 379623 on 9/26/19; c. # 300639 on 9/30/19; d. # 379549 on 10/1/19. The Histology Technician confirmed at approximately 2:30pm that the positive and negative control reactivity was not documented for the 4 patients reviewed. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with staff 6/14/18, the laboratory failed to follow policies and procedures for evaluating the competency of the providers who read KOH (potassium hydroxide) and scabies preps, Tzanck smears, and DTM (dermatophyte test medium) fungal cultures. Review of personnel records for 3 of 3 providers who read KOH (potassium hydroxide) and scabies preps, Tzanck smears, and DTM (dermatophyte test medium) fungal cultures revealed there was no documentation of competency evaluations for any of the providers since the last survey on 3/24/16. During interview at approximately 11:00 a.m., histotechnician #1 confirmed there were no competency evaluations available for 3 of 3 providers. 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 review of 2016, 2017, and 2018 patient logs and interview with TP (testing personnel) 6/14/18, the laboratory failed to verify the accuracy of the scabies preps, DTM (dermatophyte test medium) fungal cultures, and Tzanck smears at least twice a year during 2016, 2017, and 2018. Findings: 1. Review of patient logs revealed the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- laboratory had not documented any patient scabies preps since 12/10/15. During interview at approximately 12:40 p.m., TP #3 (the former laboratory director) stated that they had performed some scabies preps since then. He stated that they might have been documented as KOH preps, so it would be difficult to tell how many were actually done. He confirmed there was no documentation that the laboratory had verified the accuracy of the scabies preps at least twice a year during 2016, 2017, and 2018. 2. Review of patient logs revealed the laboratory documented verifying the accuracy of the DTM fungal cultures 1 time in 2016. The laboratory failed to document verifying the accuracy of the DTM fungal cultures during 2017, and had not documented verifying the accuracy of the DTM fungal cultures from 1/1/18 - 6/14/18. 3. Review of patient logs revealed the laboratory performed 2 patient Tzanck smears during 2016, 3 patient Tzanck smears in 2017, and 1 patient Tzanck smear from 1/1 /18 - 6/14/18. The laboratory verified the accuracy of the Tzanck smears by having two testing personnel read and document their results only 1 time in 2016 and 2017, and 1 time in 2018 from 1/1/18 - 6/14/18. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)