Austin Skin

Summary Statement of Deficiencies D0000 The Austin Skin laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of a recertification validation survey on 10/09/2025 and recertification is recommended. Standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's policy and procedures, preventive maintenance, and interview, the laboratory failed to ensure the preventive maintenance (PM) was performed annually on the Avantik QS12 cryostat for one of two years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Dermatology- Mohs Program Laboratory Manual under Equipment Quality Control for Cryostats stated, "10) Preventive maintenance and grounding check are performed yearly by Avantik." B. Interview with the histotechnologist on October 9, 2025 at 1445 hours stated he would send the 2023 and 2024 PM record via email. C. Review of the preventive maintenance showed records for 2023. Records for 2024 were requested via email on 10/13/2025 at 1355 hours but not received. II. Based on review of the laboratory's policy and procedures, preventive maintenance, and interview, the laboratory failed to ensure the preventive maintenance (PM) was performed annually on the Micronix microscope for one of two years reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Dermatology- Mohs Program Laboratory Manual under Microscope Maintenance stated, "Grounding check is monitored and ocular micrometer is calibrated yearly." B. Interview with the 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 -- histotechnologist on October 9, 2025 at 1445 hours stated he would send the 2023 and 2024 PM record via email. C. Review of the preventive maintenance showed records for 2023. Records for 2024 were requested via email on 10/13/2025 at 1355 hours but not received. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedures, pre-survey paperwork, laboratory records, and interview, the technical supervisor failed to evaluate the competency at least semi-annually during the first year the individual tested patient specimens for one of one new hire that performed Mohs testing. Findings follow. A. Review of the laboratory's policy and procedure titled Dermatology- Mohs Program Laboratory Manual, did not address competency evaluations. B. Review of the pre- survey paperwork titled Laboratory Personnel showed testing personnel #2 (as listed on the CMS form 209), began Mohs testing 09/2024 (elapsed time: 1 year, 9 days). C. Review of the laboratory records showed no semi-annual competency evaluations performed. Two competency evaluations were requested on October 9, 2025 at 1445 hours but not provided. D. Interview with the histotechnologist on October 9, 2025 at 1445 hours confirmed they had not performed semi annual competency evaluations for the Mohs surgeon. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, and interview, the laboratory director failed to sign and date three of three laboratory policies and procedures prior to use. Findings follow. A. Review of the laboratory's policies and procedures contained in Dermatology-Mohs Program Laboratory Manual, KOH Protocol, and the Mineral Oil Protocol showed the laboratory director had not signed and dated the policies and procedures. B. Interview with the Medical Assistant Supervisor on December 5, 2023 at 1130 hours confirmed the findings. 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 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) 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. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, patient testing logs, and interview, the laboratory failed to have testing procedures for KOH (Potassium Hydroxide) for fungal elements and Mineral Oil for Scabies for nine of nine months reviewed. Findings follow. A. Review of the laboratory's policies and procedures showed no policy and procedure for the KOH for fungal elements and Mineral Oil for Scabies. B. Review of patient testing logs showed the laboratory performed the following number of patient tests: 1. to date in 2022- a. KOH: 11 patient tests, accession numbers K22-001 - K22-011 b. Scabies: 0 patient tests 2. in 2021- a. KOH: 12 patient tests, accession numbers K21-001, and K21-003 - K21-013 (first tested 06 /10/2021) b. Scabies: 2 patient tests, accession numbers K21-002 and M21-001 (first tested 10/04/2021) C. Interview with the clinic supervisor on March 17, 2022 at 1215 confirmed they did not have a written policy and procedure for KOH and Scabies. 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 --