Pure Dermatology

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiency was cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, reagent log, patient testing logs, interview, and pre-survey paperwork, the laboratory failed to ensure chemicals and stains used in the Hematoxylin and Eosin (H&E) stain used to process Mohs specimens had not exceeded their expiration date by 131 out of 730 days reviewed. Findings follow. A. Review of the laboratory's policies and procedures titled Stain Maintenance and Stain Maintenance Auto-Stainer did not include any instructions on the handling of expired reagents. The laboratory's policy and procedure titled Stain Maintenance stated, "10. Be sure to log all chemicals on log lot sheet." B. Review of the Chemical Log Sheet showed: 1. Hematoxylin, Lot #166741, expiration date 8/31/2024, was opened on 4/26/2024 and the next entry was Lot # 188581, expiration date 06/30/2025, was opened on 12/13/2024 revealing an elapsed expiration of 3 months 12 days (103 days). 2. Eosin, Lot # 182702, expiration 03/31 /2025 was opened on 03/21/2025, and the next entry was [showed no data] for Eosin, Lot #224682, expiration date 09/30/2026 received on 04/29/2025 revealing an elapsed expiration of at least 28 days to receipt of new bottle. NOTE: It was unknown when the stain was put into use. C. Review of the Mohs Accession Log: 1. From 09/01/2024 - 12/13/2024 showed 23 days of Mohs testing with expired Hematoxylin with 47 cases reported (SA24-069 - SA24-115). 2. From 04/01/2025 - 04/29/2025 showed 3 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 -- days of Mohs testing with expired Eosin with 17 cases reported (SA25-048 - SA25- 064). D. Interview with Technical Supervisor #2 on July 17, 2025 at 1455 hours acknowledged they have had issues with staff keeping up with reagents and the reagent log. E. Review of the CMS Form 116 showed approximately 250 blocks were reported annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, patient testing log, and interview, the laboratory failed to document the internal controls for the Henry Schein One Step + hCG Urine Cassette Test for 6 of 6 months reviewed. Findings follow. A. Review of the Henry Schein One Step + hCG Urine Cassette Test Instructional Insert package insert, Rev 04/2014, under Quality Control stated, "Internal procedural controls are included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test results." B. Review of the HCG Test Log from 07/18/2023 to 02/07/2024 showed no results for the internal procedural controls. Review of the log showed 25 patient tests were performed. C. Interview with Technical Consultant #2/testing personnel #2 on February 7, 2024 at 1550 hours confirmed there was not a column on the pregnancy log to document the internal procedural controls. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, pre-survey paperwork, competency evaluations, and interview, the technical consultant failed to evaluate the competency at least semiannually during the first year the individual tested patient specimens for one of one semi-annual competency evaluations for KOH (Potassium Hydroxide) for fungal elements and Mineral Oil for mites testing. Findings follow. A. Review of the laboratory's policy and procedure titled Proficiency testing Competency and CLIA competency assessment, approved 07/01/2023, stated, "Evaluation and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual sees patient specimens." B. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #2 (as listed on the CMS form 209) was hired 06/19/2023. C. One semi-annual competency evaluation for testing personnel #2 was requested on February 7, 2024 at 1220 hours but not provided. D. Interview with Technical Consultant #2/testing personnel #2 on February 7, 2024 at 1220 hours confirmed a competency evaluation was not performed. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for 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 on review of the laboratory's policy and procedure, pre-survey paperwork, competency evaluations, and interview, the technical supervisor failed to evaluate the competency at least semiannually during the first year the individual tested patient specimens for one of one semi-annual competency evaluations in Mohs testing. Findings follow. A. Review of the laboratory's policy and procedure titled Proficiency testing Competency and CLIA competency assessment, approved 07/01/2023, stated, "Evaluation and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual sees patient specimens." B. Review of the pre-survey paperwork titled Laboratory Personnel showed testing personnel #2 (as listed on the CMS form 209) was hired 06/19/2023. C. One semi-annual competency evaluation for testing personnel #2 was requested on February 7, 2024 at 1220 hours but not provided. D. Interview with Technical Supervisor #2/testing personnel #2 on February 7, 2024 at 1220 hours confirmed a competency evaluation was not performed. -- 2 of 2 --