Advanced Dermasurgery Associates

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 Centers for Medicare and Medicaid Services (CMS)-116 form, laboratory policies, CMS 209 form, laboratory twice annual accuracy records, and confirmed by staff interview, the laboratory failed to verify the accuracy of non- regulated histopathology (MOHs) procedures at least twice annually for 2 of 2 testing events in 2023. Findings included: 1. Review of the CMS-116 form submitted at survey by the laboratory revealed the laboratory performed histopathology (MOHs) procedures. 2. Review of the laboratory's "Quality Assurance Program" policy stated: "Quality Assurance Indicators ... - Comparison of Test Results Twice annually, slides from randomly chosen Mohs and in-house biopsy specimens will be sent to a dermatopahologist for evaluation of slide adequacy and second opinion of results from the Mohs surgery procedure. A request will be made for consulting slides to be returned to [XX], M.D., and accompanying reports will be filed in the Mohs laboratory as part of the quality assurance record. 3. Review of CMS-209 form submitted by the laboratory revealed Testing Person-1 (TP-1) and Testing Person-2 (TP-2) performed MOHs procedures. 4. Review of the laboratory's twice annual accuracy records revealed there were no twice annual accuracy assessment records for TP-1 for 2 of 2 events 2023. 5. During an interview on 06/28/2022 at 9:42 am, the Director of Regulatory Compliance confirmed there were no twice annual accuracy assessments for TP-1 in 2023. 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 D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiency and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies 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 record review and interview with the Lab Manager, the laboratory failed to dispose of alcohol and eosin per the manufacturers instructions for 2 out of 2 years (2016-2018) reviewed. Findings Included: During an interview on 11/08/18 at 4:30 PM the Lab Manager revealed that the alcohol and eosin were disposed of down the sink with water. Review of the bottles of alcohol and eosin it revealed that the two chemicals should be disposed of at an approved waste facility. 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 on record review and interview with the Lab Manager the laboratory failed to retain temperature and humidity records for 1 (August 2018) out of 4 months (December 2016, May 2017, November 2017, and August 2018) reviewed. Findings Included: Review of cryostat temperatures, humidity, and room temperature revealed no documentation of temperatures on August 27, 29, and 30 of 2018. Review of daily quality control and patient accession numbers revealed that 14 patients were tested on 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 27th, 10 patients were tested on the 29th, and 8 patients were tested on the 30th. During an interview on 11/08/18 at 5:00 PM the Lab Manager confirmed the information was missing. 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 record review and interview with the Office Manager the laboratory failed to perform competency evaluations on 2 (#B and #C) out of 2 Clinical Consultants and 2 (#B and #C) out of 3 Testing Personnel reviewed. Findings Included: Review of personnel files revealed that Clinical Consultant #B and #C were the same person as #B and #C Testing Personnel. There was no documentation of competency assessments for being the Clinical Consultant or the Testing Personnel for either #B or #C. During an interview on 11/08/18 at 4:45 PM the Office Manager confirmed that there were no competency evaluations for #B or #C. 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 record review and interview with the Laboratory Director the laboratory failed to verify the accuracy of testing at least twice a year for 1 (2017) out of 2 years (2016-20180 reviewed. Findings Included: Review of peer reviews revealed them performed on 11/06/18, 10/27/16, and 04/11/16. During an interview on 11/08/18 at 5: 00 PM the Laboratory Director confirmed that even though performed, there was no other documentation of peer reviews being performed. -- 2 of 2 --