Vitalogy Skincare Dba (Burnet)

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency records, pre-survey paperwork, and interview, the laboratory failed to ensure the competency of 2 of 2 Technical Supervisors/General Supervisors performing Mohs testing. Findings follow. 1. Review of competency evaluations revealed no competency evaluations were performed for personnel acting in the capacity of Technical Supervisors (TS) and General Supervisors (GS) in Mohs testing. 2. Review of the pre-survey paperwork, showed TS/GS #1, as listed on the CMS form 209, began Mohs testing at the facility on 09/01/2020, and TS/GS #2 began Mohs testing at the facility on 11/20/2020. 3. Interview with the Laboratory Manager on July 6, 2022 at 1055 hours in the office acknowledged they never qualified Mohs surgeons (outside the LD) as TS/GS. 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. 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 accuracy assessments, patient testing logs, and interview, the laboratory failed to perform twice a year accuracy assessment of its Frozen sections for the dermatopathology interpretations (diagnosis) for 11 of 11 months reviewed. Findings follow. 1. Accuracy assessments for the dermatopathology interpretations of Frozen sections were requested on July 6, 2022 at 1225 hours but not provided. 2. Review of the Frozen Section Accession Log showed from 08/11/2021 - 07/06/2022 there were 2 cases/patients reported. 3. Interview with the Laboratory Manager on July 6, 2022 at 1235 hours in the office confirmed accuracy assessments for Frozens were not performed. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the patient test reports, slides, and interview, the laboratory failed to report the results of the Immunohistochemical (IHC) stains for two of nine Mohs test reports reviewed. Findings follow. 1. Review of nine Mohs cases with IHC stains, showed the patient reports for Mohs case PB22-238 was missing the result of the Mart-1 stain, and Mohs case PB21-466 was missing the result of the CK5 (Cytokeratin 5) stain. 2. Review of the case slides showed the slides for both IHC stains. 3. Interview with the Laboratory Manager on July 6, 2022 at 1245 hours in the office confirmed the results of the IHC stain were not in the reports. -- 2 of 2 --

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's quality assurance records from 2017 through 2018, patient test records for 2017 and 2018 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for KOH preparations in 2017 and 2018. Findings included: 1. A review of the laboratory's quality assurance records from 2017 through 2018 found no documentation of verification of the accuracy of results for KOH preparations. The laboratory provided one testing event for the 2017 MLE-M3 Medical Laboratory Evaluation (MLE) proficiency testing records for CLIA 45D1069391 as their own. The laboratory also provided the enrollment form for 2018 for the same laboratory. 2. Review of patient test records found that the laboratory tested 16 patient specimens for KOH between February 3, 2017 and May 16, 2018 without verifying the accuracy of the results for KOH or participating in a Proficiency testing program. 3. An interview with the clinic manager conducted on September, 2018 at 10:28 AM confirmed the laboratory was neither enrolled in a proficiency testing program nor did the laboratory have a method in place to verify the accuracy of the test results for KOH at least twice a year. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, 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 -- and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Review of policies and procedures, patient test records,verification of accuracy of results and interview of facility personnel found that the laboratory director failed to ensure that the results for KOH had been verified at least twice annually in 2017 and 2018. (see D 5217) -- 2 of 2 --