North Metro Dermatology

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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of the single Histopathology test performed in the laboratory at least twice annually in 2021. In addition, the laboratory failed to verify the accuracy of one of two Microbiology microscopic examinations at least twice annually in 2022. Findings are as follows: A. Histopathology 1. The laboratory performed Mohs micrographic surgery under the specialty of Histopathology as confirmed by the Practice Manager (PM) during a tour of the laboratory at 10:20 a.m. on 06/28/23. 2. Mohs case slide evaluation by an outside provider was required twice annually as established in the Protocol for Proficiency Testing for Mohs Surgery found in the Mohs Micrographic Surgery Procedure Manual. 3. One Mohs case was evaluated on 07/20/21. A second Mohs case evaluation was not found in 2021 laboratory records. The laboratory was unable to provide a second 2021 Mohs case evaluation upon request. 4. The laboratory performed 176 Mohs micrographic surgery procedures in 2021 as indicated in the laboratory's Mohs patient log. 5. In an interview at 11:50 a.m. on 06/28/23, the PM confirmed the above finding. B. Microbiology Microscopic Examinations 1. The laboratory performed microscopic examinations for fungus and parasites under the specialty of Microbiology as confirmed by the Practice Manager (PM) during a tour of the laboratory at 10:20 a.m. on 06/28/23. 2. Scabies parasite preparation accuracy verification via peer review was required twice annually as established in the Scabies Prep Protocol found in the Provider Performed Microscopic Procedures & CLIA Waived/Non-Waived Tests Procedure Manual. 3. Documentation of twice annual Scabies preparation accuracy verification was not found during review of 2022 laboratory records. The laboratory 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 -- was unable to provide 2022 Scabies preparation accuracy verification documentation upon request. 4. The laboratory performed two Scabies preparation microscopic examinations in 2022 as indicated in the laboratory's Point of Care Scabies Work Sheet testing log. 5. In an interview at 12:55 p.m. on 06/28/23, the PM confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to dispose excess Histopathology tissue in accordance with applicable Federal, State, and local requirements. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery testing as confirmed by the Clinic Manager (CM) during a tour of the laboratory at 10:05 a.m. on 06/19/19. 2. Excess tissue was to be treated as biohazardous waste and disposed according to Federal, State, and local laws as established in the Mohs Micrographic Surgery procedure located in the Mohs Micrographic Surgery Procedure Manual. 3. A biohazard container for excess tissue was not observed in the laboratory during the tour. 4. In an interview at 10:30 a.m., the Medical Assistant confirmed excess tissue was discarded in a regular trash bin after verifying this information via a telephone conversation with the Mohs technician. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). 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 document review and interview with laboratory personnel, the laboratory failed to document the time of Histopathology specimen receipt into the laboratory for 2 of 3 Mohs Micrographic Surgery cases reviewed. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery testing as confirmed by the Clinic Manager (CM) during a tour of the laboratory at 10:05 a.m. on 06/19/19. 2. A requirement to document the time of tissue receipt on the Mohs map was established in the Mohs Micrographic Surgery procedure located in the Mohs Micrographic Surgery Procedure Manual. 3. The time of subsequent surgery stage tissue receipt was not documented on the Mohs map for 2 of 3 Mohs cases reviewed on date of survey as indicated below. The laboratory was unable to provide alternate records of specimen receipt time upon request. Case Date Stages N-M18-083 B 06/07/18 III The time of Stage III tissue receipt not documented. Case Date Stages N-M18-208 12/07 /18 II The time of Stage II tissue receipt not documented. 4. In an interview at 12:10 p. m., the Medical Assistant confirmed the above finding. -- 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 document review and interview with laboratory personnel, the laboratory failed to perform and document activities used to verify the accuracy of Microbiology and Histopathology test procedures at least twice annually. Findings are as follows: The laboratory performed Microscopic Examinations for parasites and fungus under the specialty of Microbiology and Mohs Micrographic Surgery testing under the subspecialty of Histopathology as confirmed by the Practice Manager during a tour of the laboratory on 01/11/18 at 10:15 a.m. The laboratory began Histopathology testing in August 2017 and Microscopic Examinations in 2013. Microscopic Examinations 1. The Table of Contents for the laboratory's CLIA manual indicated verification of accuracy for non-waived tests (Microscopic Examinations) would be performed twice annually for each eligible physician. 2. Documentation of the 2017 Microscopic Examination verifications was not found in laboratory records. The laboratory was unable to provide verification documentation from 2017 upon request. 3. In an interview on 01/11/18 at 11:23 a.m., Office Personnel 1 confirmed Microscopic Examination accuracy had not been verified in 2017. Mohs Micrographic Surgery 1. A twice annual verification of accuracy requirement for the Mohs Micrographic Surgery testing was established in the laboratory's CLIA manual. 2. Documentation of the 2017 Mohs Micrographic Surgery verification was not found in laboratory records. The laboratory was unable to provide verification documentation from 2017 upon request. 3. In an interview on 01/11/18 at 11:00 a.m., the Mohs Technician confirmed Mohs Micrographic Surgery accuracy had not been verified in 2017. D5403 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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)