St Luke's Dermatology

Summary Statement of Deficiencies D0000 The Aspirus St Luke's Dermatology laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on March 05, 2026. The following standard-level deficiency was cited: 493.1236 Evaluation of proficiency testing performance 493.1407 Laboratory director responsibilities . 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 1 of 3 Provider Performed Microscopy (PPM) examinations at least twice annually in 2025. Findings are as follows: 1. The laboratory performed PPM examinations for fungus, parasites, and viruses under the specialty of Microbiology as confirmed by the Clinic Manager (CM) during a tour of the laboratory at 1:05 p.m. on 03/05/26. 2. Requirements for twice annual verification of accuracy testing for parasites were established in the Procedure for Preparing and Interpreting Wet Preparations of the Skin found in the Log & Procedure Manual for Scrapings - KOH, Wet Prep, Tzanck. 3. A single parasite accuracy verification document from 2025 was found during review of laboratory records on date of survey. The laboratory was unable to provide documentation of an additional parasite verification upon request. 4. The laboratory's patient testing log indicated two patient samples received microscopic examinations for parasites in 2025. 5. In an interview at 3:15 p.m. on 03/05/26, the CM confirmed the above finding. *This deficiency was previously cited during the 04/07/16 and 02 /24/22 surveys* . 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 -- D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: . Based on review of laboratory policies and procedures, quality control logs, and previous survey data, the Laboratory Director failed to ensure previously cited deficiencies were corrected in 2025. Findings are as follows: The following deficiency was cited during the 04/07/16 and 02/24/22 surveys and was also out of compliance on 03/05/26. D5217 - the laboratory failed to perform and document activities used to verify the accuracy of Provider Performed Microscopy examinations at least twice annually in 2025 -- 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 2 of 3 microscopic examinations at least twice annually in 2020 and 3 of 3 microscopic examinations at least twice annually in 2021. Findings are as follows: 1. The laboratory performed microscopic examinations for fungus, parasites, and viruses under the specialty of Microbiology as confirmed by the Clinic Manager (CM) during a tour of the laboratory at 10:00 a.m. on 02/24/22. 2. Requirements for twice annual verification of accuracy testing were established in the laboratory's procedures for performing KOH fungal and yeast preparations (KOH), wet preparations of the skin (WP), and Tzanck preparations (T). 3. Verification of accuracy records for 2020 and 2021 reviewed on date of survey did not include the required number of verifications for each test . See below. 2020 Test Number of verifications WP 0 T 1 2021 Test Number of verifications KOH 1 WP 1 T 1 The laboratory was unable to provide additional verification documentation upon request. 4. The laboratory's patient log indicated patient samples received microscopic examinations for fungus, parasites, and viruses in 2020 and 2021. See below 2020 Test Number of patients WP 4 T 1 2021 Test Number of patients KOH 35 WP 4 T 1 5. In an interview at 12:35 p.m. on 02/24/22, the CM confirmed the above finding. . D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease 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 -- nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory staff, the laboratory failed to retain lot number and expiration date records for 2 of 2 stains used for Histopathology testing. Findings include: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Clinic Manager during a tour of the laboratory at 10:00 a.m. on 02/24/22. 2. Laboratory policies and procedures did not include instruction to record and retain Hematoxylin and Eosin (H&E) stain lot numbers and expiration dates. 3. Documentation of H&E stain lot numbers and expiration dates was not found during review of laboratory records from September 2020 through February 2022. 4. The laboratory was unable to provide the required documentation upon request. 5. In an interview at 12:25 p.m. on 02/24/22, the Histotechnician confirmed the above finding. . 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 document review and interview with laboratory personnel, the laboratory failed to ensure all test result reports included the address of the laboratory location. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Clinic Manager during a tour of the laboratory at 10:00 a.m. on 02/24/22. 2. The address of the laboratory location was not included on test result reports reviewed on date of survey. See below Case number Date of testing M20-377 12/22/20 M21-336 11/15/21 3. The estimated Histopathology annual test volume was 388 as indicated on the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification Form CMS-116 obtained during the survey. 4. In an interview at 12:15 p. m. on 02/24/22, the CM confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to document temperatures for the cryostat for multiple dates in 2018, 2019 and 2020. Findings are as follows:: 1. The laboratory performed Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Mohs Technician (MT) during a visual observation of the laboratory on 9/17/20 at 10: 00 a.m. 2. The Leica CM1850 Cryostat was observed as present and available for use during a visual observation of the laboratory. 3. Based on a review of the Mohs patient log, daily temperatures for the above equipment were not documented on the following dates on which Mohs surgery patients were tested: Date # of Mohs cases performed 7/24/18 4 9/6/18 3 12/3/18 5 12/4/18 5 12/20/18 4 10/30/19 4 10/31/19 5 11 /19/19 4 2/03/20 3 2/25/20 5 7/28/20 3 4. The laboratory was unable to provide the cryostat temperature documentation upon request. 5. In an interview on 9/17/20 at 12: 45 p.m., the MT confirmed the above findings. . D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, 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 -- manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to document Histopathology quality control (QC) performance. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Mohs Technician (MT) during a visual observation of the laboratory on 9/17/20 at 10:00 a.m. 2. A patient case (M20-114) from 4/30/2020 was reviewed. 3. Documentation of 04/30/20 QC slide performance was not included in the written log. 4. In an interview on 9/17/20 at 12:45 p.m., the MT confirmed the above findings. . -- 2 of 2 --