Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Oasis Dermatology PLLC on July 9, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the laboratory failed to store four 100% Reagent Alcohol containers, three XS-3 Xylene Substitute containers and one reagent waste jug in a flammable cabinet. Findings Included: 1. On 7/10/26 at 11:05 AM, 4 100% Reagent Alcohol and 3 XS-3 Xylene Substitute were stored in a cabinet. A reagent waste jug was stored on the floor. 2. Review of XS-3 Xylene Substitute sticker read, "store in a dry, cool, locked place. Keep container tightly closed in a fireproof place." 3. Review of 100% Reagent Alcohol sticker read "Highly Flammable liquid and vapor. Store in locked, dry, cool and well-ventilated place." 4. On 7/09/26 at 1:08 PM, the Office Manager confirmed 100% Reagent Alcohol, XS-3 Xylene Substitute and reagent waste jug were not stored properly. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(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 -- Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on interview and record review, the laboratory failed to document the cryostat and stain line maintenance for 5/15/26 and 5/29/26. Findings Included: 1. Review of Mohs micrographic surgery (Mohs) log revealed Mohs testing was performed on 5/15 /26 and 5/29/26. 2. Review of Cryostat Maintenance revealed room temperature, humidity and Cryostat temperature were not documented for 5/15/26 and 5/29/26. 3. Review of Manual stain line revealed stain line changes were not documented for 5/15 /26 and 5/29/26. 4. Review of Daily Quality control log Cryostat Maintenance read "acceptable humidity reading range up to 65%, acceptable room temperature 68 F to 80 (F) Fahrenheit, acceptable cryostat temperature -14 C to -30 Celsius (C). 5. On 7/09 /26 at 1:08 PM, the Office Manager stated cryostat and stain line maintenance for 5/15 /26 and 5/29/26 could not be located. 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. This STANDARD is not met as evidenced by: Based on interview and record review, the laboratory failed to document quality control acceptability for Hemoxylin and Eosin for 5/15/26 and 5/29/26. Findings Included: 1. Review of Mohs micrographic surgery (Mohs) log revealed Mohs testing was performed on 5/15/26 and 5/29/26. 2. Review of the Daily Quality Control worksheet revealed daily quality control was missing between 5/15/26 and 5/29/26. 3. Review of Quality Control Measures for Modified Hematoxylin & Eosin and/or Toluidine Blue Routine stain read, "the laboratory director will review the slide in order to evaluate the stain quality. 4. On 7/09/26 at 1:08 PM, the Office Manager stated daily quality control logs could not be located. -- 2 of 2 --