Omni Dermatology, Inc

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 lack of accuracy verification documentation for the microscopic interpretation of Frozen Biopsy specimens and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2024. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of the microscopic interpretation of Frozen Biopsy specimens at least twice annually during 2024. 2. The facility personnel interviewed on 9/15/25 at 11:40 AM confirmed the laboratory failed to verify the accuracy of Histopathology testing at least twice annually during 2024. 3. The laboratory performed four frozen biopsies in 2024. 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: Based on review of test procedures for testing performed under the subspecialty of Histopathology and interview with the facility personnel, the laboratory failed to 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 -- establish a written test procedure for Frozen Section Biopsy testing. Findings include: 1. The laboratory performs testing under the subspecialty of Histopathology with a reported annual test volume of 540. 2. No documentation was presented for review during the survey conducted on 9/15/25 to indicate the laboratory established a written test procedure for Frozen Section Biopsy testing. 3. The facility personnel interviewed on 9/15/25 at 11:40 AM confirmed the laboratory failed to establish a written test procedure for Frozen Biopsy testing. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation of histopathology stain reagents and interview with the facility personnel, the laboratory used the stain reagent, Hematoxylin, past the expiration date. Findings include: 1. The laboratory performs the Hematoxylin and Eosin (H&E) stain on patient slides in conjunction with Mohs, with an approximate annual test volume of 540. 2. During the survey conducted on June 25, 2024, direct inspection of the Hematoxylin reagent, lot #160919, indicated an expiration date of May 31, 2024. 3. The laboratory used the expired reagent during one day of testing conducted on 6/19/2024. Approximately 19 patients were tested using the expired reagent. 4. The facility personnel interviewed on 6/25/2024 at 10:20 AM confirmed the expired reagent indicated above was in use at the time of the survey. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 patient test results maintained in the electronic medical record (EMR), review of the laboratory log used to record patient test results, review of the Mohs map, review of patient slides and interview with the facility personnel, the laboratory failed to accurately report the Mohs test result for one out of four patient records reviewed. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 540. 2. The laboratory utilizes an electronic medical record (EMR) system to document the Mohs test procedure and Mohs test results. The final test result information is manually transcribed by laboratory personnel into the patient's EMR. 3. The laboratory failed to correctly enter (manually transcribe) the number of Mohs stages in the EMR for one patient record reviewed during the survey, case# WM23-38. The Mohs log, patient slides and Mohs map for this patient indicated a total of 1 stage, and the operative note (final test result) entered in the EMR indicated a total of 2 stages. 4. The facility personnel interviewed on 6/25/2024 at 10:00 AM confirmed that the laboratory failed to accurately report the final test result in the EMR for the patient indicated above. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of Mohs test reports and interview with the facility personnel, the laboratory failed to establish policies and procedures for amending pathology reports. Findings include: 1. The laboratory performs Mohs testing on patient specimens under the sub-specialty of histopathology, with an approximate annual test volume of 540. The laboratory utilizes an electronic medical record (EMR) system to maintain patient records 2. Review of the Mohs test report for case# WM23-38 indicated the date of service as 2/17/23, and the test report was originally signed by the physician who made the diagnosis on 2/20/23. Information maintained in the EMR indicated the test report was amended and listed the 'amendment sign-off' date as 6/27/23. 3. The laboratory failed to provide documentation as to why the test report indicated above was amended on 6/27/23. 4. No documentation was presented for review during the survey to indicate the laboratory established policies and procedures for amending pathology reports. 5. The facility personnel interviewed on June 25, 2024 at 10:10 AM confirmed the laboratory failed to establish policies and procedures for amending pathology reports, and failed to identify why the Mohs test report indicated above was amended on 6/27/23. -- 2 of 2 --

Summary Statement of Deficiencies 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 laboratory's test reports for Mohs testing, test records for Mohs testing and interview with the facility personnel, the laboratory failed to include the test result on one test report reviewed during the survey. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 250. The laboratory utilizes an electronic medical record (EMR) system to document the test procedure and test results. 2. One out of four Mohs test reports reviewed during the survey (WM18-34) failed to include the final test result for Mohs. The EMR reviewed for this patient indicated, "Microscopic examination of the tissue revealed". 3. The facility personnel confirmed that the EMR for case# WM18-34 failed to include the final test result. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. 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 monthly Quality Assessment (QA) documentation, review of electronic test records and interview with the facility personnel, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified with electronic test reports. Findings include: 1. The laboratory performs Mohs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 250. The laboratory utilizes an electronic medical record (EMR) system to document the test procedure and test results. 2. No documentation was provided for review during the survey to indicate the laboratory established policies and procedures to monitor the Mohs test results entered into the EMR. 3. The laboratory failed to document the test results in the EMR for one out of four patient records reviewed during the survey. See D5805 for findings. 4. The facility personnel confirmed that the laboratory's established QA procedures failed to monitor the test report information entered into the EMR. -- 2 of 2 --