Indigo Dermatology Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 11, 2024 to July 16, 2024. Indigo Dermatology LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 procedure manual, previous surveyor notes, peer review records, and interview, the laboratory failed to have a policy and verify the accuracy of the reading and interpretation of the Hematoxylin and Eosin stain (peer review) at least twice annually for Testing Personnel A in 2022 and Testing Personnel A and B in 2023. Findings: Review of the procedure manual revealed the laboratory was missing a procedure on peer review. On 07/11/2024 at 11:35 AM, the Mohs Technician stated he did not know where the policy on peer review was located. Review of the survey notes from the survey on 05/16/2022, showed peer review was performed in April 2022 for Testing Personnel B. Peer review records for 2022 were not available for review. Review of the QC and QA records received on 07/16/2024 at 2:57 PM revealed peer review records for 2022 were not included. Review of the Quality Control / Peer Review listed eight cases on page one and four cases on page two. The first five cases on page one were peer review for Testing Personnel A and the last three cases were peer review for Testing Personnel B. The dates of the cases on page one, in order were 12/20/2023, 12/18/2023, 12/18/2023, 02/06/2024, 01/09 /2024, 01/03/2024, 12/12/2023, and 12/12/2023. The first three cases on page two were peer review for Testing Personnel B and the last case was peer review for Testing Personnel A. The dates of the cases on page two, in order were 12/14/2023, 12 /12/2023, 02/12/2024, and 02/06/2024. Review of the Quality Control / Peer Review 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 -- showed there was no date listed as to when the peer review was performed. There were no other peer review records. On 07/11/2024 at 11:24 AM, the Mohs Technician stated he did not know when the peer review was sent out for review. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 5, 2020. Indigo Dermatology LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory's Quality Assessment Program failed to monitor and evaluate the overall quality of the analytic system and correct identified problems. Cross Reference D5403: Based on observation, record review and interview, the laboratory procedure manual failed to include the instructions for making the 95% reagent grade alcohol in their H&E (Hematoxylin and Eosin) stain. Cross Reference D5601: Based on record review and interview, the laboratory failed to have negative control slides for recording the negative reactivity for each Immunohistochemical (IHC) stains from 8/5/18 to 8/5/20. Cross Reference D5609: Based on record review and interview, the laboratory failed to document the lot number, expiration date and open dates for reagents used in their Hematoxylin & Eosin (H & E) stains from 7/8/18 to 8/5/20 (July 2018 - March 2019, May 2019 - August 2019, November 2019 - February 2020, July 2020 - August 2020) for 19 out of 26 months (July 2018 - August 2020). This is a repeat deficiency from the survey performed on 6/19/18. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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, the laboratory failed to follow their policy to access employees competency. Findings: Review of the laboratory logs and quality assurance documentation showed that there was no documentation of initial training or competency accessment for the Mohs technician from 1/28/17 to 6/19/18. During an interview on 6/19/18 at 11 AM, the Office Manager stated they only had the Mohs technicians resume and a brief typed statement, and that no other training or competency was documented. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)