Premier Procedural Dermatology Pllc

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on 03/14/2025. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on direct observation of patient slides, review of laboratory policy, and confirmed in an interview with laboratory personnel, the laboratory failed to follow its slide labeling policy for 3 of 9 slides randomly selected for review from January 2024 and January to February 2025. The findings were: 1. Based on direct observation performed on March 14, 2025, the surveyor reviewed 9 randomly selected slides from January to February 2025. Case #A24-032 1 of 3 slides failed to include the patient's name Case #A24-041 1 of 2 slides failed to include the patient's name Case #A25-027 1 of 2 slides failed to include the patient's name 2. Review of the laboratory's policy titled, "Slides", stated, "1.Label each slide with patient's name, case #, cut (stage) and specimen #..." 3. The findings were confirmed in an interview with the histotechnologist on March 14, 2025, at 08:45 a.m. in the waiting area. 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 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 the laboratory records, policies and procedures quality assurance records from 2019 through 2021, patient test records for 2020 and 2021 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for Histopathology procedures in 2020. Findings included: 1. Review of the policy / procedure titled QUALITY ASSURANCE / QUALITY found: "every six months, microscope slides from two Mohs surgical cases will be chosen from the previous six months and sent out to an outside source for review for quality assurance and / or quality control. One Basal cell and one Squamous cell carcinoma case will be sent out." 2. A review of the laboratory's quality assurance notebook found two cases were sent out for accuracy assessment on August 4, 2020 and January 2021. . 3. Review of patient test records for biopsies performed in 2020 found the laboratory performed 18 biopsies, interpreting the results of the tissues onsite. 4. An interview with the Histotechnologist and the Laboratory director conducted on May 19, 2021 at 2:57 PM confirmed that the laboratory failed to assess the accuracy of Mohs surgical procedures at least twice in 2020; and did not assess the accuracy of results for the interpretation of biopsy results. 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 --