Darst Dermatology, Pc

Summary Statement of Deficiencies 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 2024 and 2025 verification of accuracy records, lack of documentation, interview with laboratory director (LD) and interview with practice manager (PM) 05/14/25, the laboratory failed to verify the accuracy of the Mart 1 immunostain and the Periodic Acid-Schiff (PAS) stain at least twice annually since January of 2024; approximately 152 Mart 1 and 32 PAS stains were performed since January of 2024. Findings: Review of 2024 and 2025 verification of accuracy records revealed the laboratory sends out hematoxylin and eosin (H&E) stained slides to another pathologist for a verification of accuracy twice annually. There was no documentation the laboratory sent Mart 1 or PAS stained slides for a verification of accuracy since January of 2024. Interview with LD at approximately 11:45 a.m. confirmed the laboratory failed to verify the accuracy of the Mart 1 and PAS stains. He stated they were not aware of this requirement. Interview with PM at approximately 11:45 confirmed approximately 152 Mart 1 and 32 PAS stains were performed since January of 2024. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. 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 procedures, review of 2024 and 2025 "Cryostat Quality Control...Equipment Quality Control" logs and interview with testing personnel (TP) #1, 05/14/25, the laboratory failed to document and/or perform established maintenance protocol of the cryostat instrument. 1. The laboratory failed to document the cryostat thermometer temperature each day of use since January of 2024. Findings: Review of laboratory procedure "Equipment Quality Control...Form 3: Cryostat and Microtome Use Protocol" revealed "8. Cryostat thermometer check is done Monthly and As Used.". Review of 2024 and 2025 "Cryostat Quality Control... Equipment Quality Control" logs revealed the laboratory was documenting the cryostat temperature check monthly and not each day of use. Interview with TP #1 at approximately 1:00 p.m. confirmed the temperature check was documented monthly and not each day of use. They stated they were just following what was previously documented on the logs when they began employment. 2. The laboratory failed to document and/or perform the defrost of the cryostat every 2 months. Findings: Review of laboratory procedure "Equipment Quality Control...Form 3: Cryostat and Microtome Use Protocol" revealed "4. Defrost of cryostat is done Every two months.". Review of 2024 and 2025 "Cryostat Quality Control...Equipment Quality Control" logs revealed the laboratory documented the defrost of the cryostat in December of 2024 and in April of 2025, a period of approximately 5 months between defrosting of the cryostat. Interview with TP #1 at approximately 1:00 p.m. confirmed there was no documentation of a defrost performed between December of 2024 and April of 2025. They stated it was performed but they must have not documented it. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based of review of laboratory procedure, review of TP #1 personnel records, lack of documentation and interview with LD 05/14/25, the technical supervisor (TS) (laboratory director) failed to perform semiannual performance assessments for TP #1 during the first year of testing patient specimens. Findings: Review of laboratory quality assessment procedure revealed "The competency of Testing Personnel...will be evaluated and documented every year by the Laboratory Director...CLIA regulations for laboratories performing Moderate and High complexity testing require semiannual performance assessments during the first year and annual assessments thereafter.". Review of TP #1 personnel records revealed TP #1 began employment in April of 2024 and a performance assessment was completed in December of 2024. There was no documentation of a second performance assessment during the first year of testing patient specimens. Interview with TS (laboratory director) at approximately 1:30 p.m. confirmed a second performance assessment was not completed for TP #1, they stated they had not hired a new employee for a long time and did not realize this was required. -- 2 of 2 --

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory procedures, review of the manufacturer's instructions, review of QC(quality control) and patient records, and staff interview 3 /30/22, the laboratory failed to check and record negative reactivity each time of use for the MART-1 IHC(immunohistochemical) stain. Findings: The laboratory's "Positive and Negative Controls for Histopathology" procedure states, "..Normal skin specimens may be generated from excess tissue specimens that would normally be discarded and has been found to be negative for disease process on previous testing. These blocks would be negative controls for many studies..." The Bio-Care Medical MART-1 Cocktail product insert revealed, "limitations:...The clinical interpretation of any positive or negative staining should by complemented by morphological studies using proper positive and negative internal and external controls..." Review of MART- 1 QC logs revealed slide quality documented for each day slides are read. Review of a computer-generated patient and QC log revealed documentation for each case where MART-1 stain was performed. Approximately 625 patients had MART-1 IHC stain performed from time of last survey in May 2019 to March 2022, a period of approximately 34 months. At approximately 11:40 a.m., the Histotechnologist confirmed they are staining a positive control each time of use. She stated the computer-generated patient and QC log showed that the positive control was stained 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 -- correctly for each case performed. At approximately 12 p.m., the Laboratory Director confirmed they are only documenting the positive control reactivity for MART-1 IHC stain. -- 2 of 2 --