Ssm Health Dean Medical Group - N High Point Rd

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) (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 surveyor review of laboratory records and results in the electronic medical record (EMR) and interview with the Laboratory Manager (Staff A), one of three reports reviewed for patients with Mohs procedures performed by Staff B that included more than one source did not identify the tissue source with the procedure note. Additionally, the sample identification noted in the Mohs log and the 'Mohs Pathology Report' maps did not correlate with the EMR report. Findings include: 1. Review of the Mohs log showed patient 1 had Mohs procedures performed on two sites on December 17, 2024. The log showed: Sample number / time received / source 1A / 9:05 AM / right superior lateral cheek 2A / 9:20 AM / right upper cutaneous lip 2. Review of the 'Mohs Pathology Report' maps showed the sample from the right superior lateral cheek was 1A and the sample from the right upper cutaneous lip was 2A. 3. Review of the EMR record for patient 1 on December 17, 2024, included the statement "Mohs surgery of 2 sites (right upper cutaneous lip and right superior lateral cheek) performed today". The EMR included separate sections, Procedure 1 and Procedure 2, with the details of each procedure. The Procedure 1 and Procedure 2 sections did not specify the tissue source. Review of two additional Mohs cases with multiple sites performed by Staff B in 2024 showed the tissue source was identified 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 -- with each procedure description in the EMR, the identified sources were concordant with the information in the Mohs logbook. 4. Interview with Staff A on March 5, 2025, at 1:30 PM confirmed the tissue source was not identified with the procedure details in the EMR and confirmed the procedure descriptions were not consistent with the information in the Mohs log. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of procedures and proficiency testing (PT) records from 2023 and 2024, and interview with the Laboratory Technical Specialist - Point of Care (Staff A), PT samples for KOH (potassium hydroxide) testing from three of five events and PT samples for Scabies testing from four of six events were sent to and tested at one of two other laboratories, Laboratory A and Laboratory C, and were not tested at this laboratory. Results were submitted to the AAB-Medical Laboratory Evaluation (AAB-MLE) PT program under this laboratory's (Laboratory B) account for all events. Findings include: 1. The Laboratory A Dermatology area and Laboratory C each received PT materials for KOH and Scabies tests from Laboratory B during 2023 and 2024. 2. Results from PT sample testing in the dermatology area of Laboratory A and Laboratory C were reported as results for Laboratory B's account to AAB-MLE, the PT provider. 3. Laboratory B performed KOH testing on patient dermatology samples and performed scabies testing. Laboratory B was enrolled in the AAB-MLE PT program for this testing. See D2013. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) 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 -- The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on surveyor review of procedures and proficiency testing (PT) records from 2023 and 2024, and interview and email with the Laboratory Technical Specialist - Point of Care (Staff A), Staff A transported AAB-Medical Laboratory Evaluation (AAB-MLE) PT samples for KOH (potassium hydroxide) and Scabies tests from this laboratory, Laboratory B, to either Laboratory A or Laboratory C for three of five KOH testing events and four of six Scabies testing events. Findings include: 1. The 'QSE-AS-Proficiency Testing Policy', effective date May 19, 1994, stated in the "Points of Emphasis" section, "PT samples must not be sent to another laboratory for testing." 2. Review of PT records from 2023 and 2024 showed testing personnel in this laboratory, Laboratory B, performed KOH PT testing on samples from event two in 2023 and event one in 2024 and performed Scabies PT in event one in 2023 and event one in 2024. Records showed Laboratory B received five events for KOH testing and six events for Scabies testing in 2023 and 2024. i. Proficiency records from AAB-MLE showed Scabies PT samples were tested at the following laboratories: Event one 2023: Laboratory B Event two 2023: Laboratory C Event three 2023: Performing Laboratory not identified on PT records Event one 2024: Laboratory B Event two 2024: Laboratory A Event three 2024: Laboratory A ii. Proficiency records from AAB-MLE showed KOH PT samples were tested at the following laboratories: Event two 2023: Laboratory B Event three 2023: Laboratory A Event one 2024: Laboratory B Event two 2024: Laboratory A Event three 2024: Sample K12 Laboratory A Event three 2024: Sample K11 Laboratory C iii. Review of the AAB-MLE submission reports showed the CLIA number of the laboratory as that of Laboratory B. The result reports from AAB-MLE showed Laboratory B's CLIA number with the laboratory name, "SSM Health Dean Med CRP" and identified the address of the laboratory as 752 North High Point Rd, Madison, Wisconsin 53717. 3. Interview with Staff A on December 3, 2024, at 12:50 PM and 3:30 PM confirmed Staff A transported PT samples from Laboratory B to Laboratory A or Laboratory C when the PT was not performed at Laboratory B. Further interviewed confirmed staff at Laboratory B performed patient KOH testing on dermatology samples and performed Scabies testing. 4. Email communication with Staff A on December 4, 2024, at 12:48 PM revealed the Scabies test for event three 2023 was performed at Laboratory A. -- 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 surveyor review of laboratory dermatopathology records and interview with the laboratory manager, the laboratory has not evaluated the accuracy of Mohs testing twice annually in 2018. Findings include: 1. Review of laboratory dermatopathology records from 2018 show no evidence of twice annual accuracy evaluation for Mohs test results. 2. Email communications with the laboratory manager on April 19, 2019 at 1:26 PM confirmed twice annual accuracy verification of Mohs test results had not been performed in 2018. This is a repeat deficiency previously cited February 12, 2013. 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 surveyor review of laboratory records and interview with 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 -- manager, the laboratory has not documented cryostat temperature, room temperature, and room percent humidity each day of patient testing to ensure conditions are acceptable for test system operations. Findings include: 1. Review of the "Mohs Laboratory Maintenance Log" and the patient accession log show that cryostat temperatures for two of two cryostats, room temperature, and room percent humidity were not documented for 32 out of 42 days patient testing was performed in 2018 in the dermatopathology laboratory. 2. Email communication with the laboratory manager on April 17, 2019 at 8:41 AM confirms the laboratory maintenance was not documented as required for all of the days patient testing was performed in 2018 in the dermatopathology laboratory to ensure conditions were acceptable for test system operations. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the laboratory manager, the laboratory did not document the quality control check on the Hematoxylin and Eosin (H&E) stain each day of patient testing to ensure stain quality. Findings include: 1. Review of the "Mohs Laboratory Maintenance Log" show that Hematoxylin and Eosin (H&E) stain quality control check was not documented for 32 out of 42 days patient testing was performed in 2018 in the dermatopathology laboratory. 2. Email communication with the laboratory manager on April 17, 2019 at 8:41 AM confirms the laboratory did not document stain quality as required for 32 out of 42 days patient testing was performed in 2018 in the dermatopathology laboratory. -- 2 of 2 --