Dermatology And Advanced Skin Care

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on procedure manual and proficiency testing (PT) record review and interview with laboratory staff, the laboratory failed to ensure that histopathology PT results were evaluated and the review documented. Findings: 1. The procedure, "Quality Assurance Program" states that the laboratory should "submit 2 cases every six months to an outside Pathologist" for PT, and that "the Pathology report is attached to and retained as a method for proficiency testing." 2. PT record review showed that the laboratory fills out the "Quality assurance, proficiency testing" form with the case number of each of the two cases submitted to the outside pathologist for PT. The form requires the outside pathologist to evaluate the "Sectioning quality," "Staining quality," and to circle a "Diagnosis" of "Negative (no tumor) / Positive (tumor) / Benign lesion." The form is signed by the outside pathologist. 3. A review of PT records from 2023 and 2024 showed that on 10/10/2023 the outside pathologist interpreted "Case # 23-140" as "Negative" and "Case # 23-290" as "Positive"; on 02/22 /2024 they interpreted "Case # 23-576" as "Negative" and "Case # 24-33" as "Benign lesion"; and on 12/09/2024 they interpreted "Case 24-171" as "Positive" and "Case # 24-400" as "Benign lesion." 4. The PT records did not include the pathology report for each case, which documents the original interpretation. There was no documentation on three of three "Quality assurance, proficiency testing" forms reviewed that the laboratory director had evaluated the PT results and determined whether the laboratory had passed the PT. 5. During an interview on 01/15/2025 at 12:45 PM the laboratory staff confirmed that the laboratory failed to evaluate and document the results of histopathology PT. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based of review of patient records, interview with the testing person and laboratory support staff, the laboratory did not retain all patient MOHS maps that are used for mapping patient tumors during surgery. Findings: 1. The laboratory did not have Patient "A" MOHS surgery map that was used during the surgery for mapping the collected tumor prior to preparing the patient slides for review. 2. The patient sample was colleted on 9/21/18 and the laboratory staff nor the testing person was able to find the original MOHS map. 3. The laboratory sent a duplicate copy of the map by email and stated that the original was unable to be found. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory records, interview with the testing person and laboratory support staff, the laboratory did not perform maintenance and function checks for the autoclave. Findings: The laboratory did not perform a spore check on the autoclave since the year 2014. The laboratory support person stated that she was 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 -- unaware that maintenance and function checks were needed for the autoclave and therefore was not performed. -- 2 of 2 --