Deaconess Clinic Inc/Downtown

Summary Statement of Deficiencies D0000 A complaint survey was completed 04/30/2026. The following condition-level deficiencies were found to be out of compliance: D5200 42 CFR 493.1230 Condition: General Laboratory Systems D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, lack of documentation, and staff interviews, the laboratory failed to ensure the following: Employee competency was assessed for one of five testing personnel who performed high complexity Histopathology slide reading in 2023, 2024, and 2025 (Refer to D5209). Twice annual verification of microscopic slide review accuracy was completed for one of five testing personnel who performed high complexity Histopathology slide reading in 2023, 2024, and 2025 (Refer to D5217). Quality Assessment reviews included one of five testing personnel in 2023, 2024, and 2025. (Refer to D5293) 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interviews, the laboratory failed to assess employee competency for one of five testing personnel performing high complexity Histopathology testing for 2023, 2024 and 2025. Findings include: 1. In interview on 4/21/2026 at 1:15 pm, E1 (Practice Administrator) stated that E2 (Testing Personnel) performed Histopathology slide reading at their location. 2. E2 analyzed the following patients' Histopathology samples microscopically: Patient Resulted Clinical Diagnosis P1 08/09/2023 SCC P2 07/13/2023 Melanoma in situ P3 08/15/2024 SCC in situ P4 08/16/2024 BCC P5 09/24/2025 S. Keratosis v/s A.Macule P6 09/25/2025 A. Keratosis/SCC in situ P7 02/23/2026 BCC 3. Upon request for yearly competency for E2 on 4/21/26 at 2:55 pm, E1 confirmed that no competency assessment was completed for E2 for 2023, 2024, and 2025. 4. In interview on 4/21 /2026 at 2:55 pm, E1 confirmed testing performed by E2 was billed under this CLIA number. 5. Review of the Laboratory Personnel Report (CLIA), signed 4/23/2026 by owner representative E5, showed the laboratory listed five high-complexity testing personnel performing Histopathology testing, including E2. Legend: BCC-Basal Cell Carcinoma E-Employee P-Patient SCC- Squamous Cell Carcinoma S.Keratosis - Seborrheic Keratosis A. Keratosis-Actinic Keratosis A. Macule - Asymmetric Macule v/s- versus 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 record review, lack of documentation, and interviews, the laboratory failed to verify the accuracy of the Histopathology microscopic slide review completed by one of five testing personnel twice annually for 2023, 2024, and 2025. Findings include: 1. In an interview on 4/21/2026 at 1:15 pm, E1 (Practice Administrator) stated E2 (Testing Personnel) performed Histopathology slide reading at their location. 2. E2 analyzed patient Histopathology samples microscopically from August 9,2023 to February 23, 2026. (Refer to D5209) 3. Upon request for twice annual verification of E2's microscopic slide reading on 04/21/2026 at 2:55 pm, E1 confirmed that the laboratory did not complete twice annual verification for E2's for 2023, 2024, and 2025. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain Mohs micrographic surgery (Mohs) quality control (QC) slides for two (PT#1 and PT#4) out of six patients reviewed. Findings included: 1. "Mohs Laboratory Procedure Manual", signed by laboratory director on 1/2/23, under section "Daily Quality Control for Hematoxylin and Eosin Stains" states "All slides are retained and kept on file at the facility." 2. Review of Mohs patient reports and slides revealed the following: a. PT#1 had no QC slide with 15 slides read on 4/1/2021. b. PT#4 had no QC slide with three slides read on 9/2/2021. 3. During interview on 1/31/2023 at 12:44 PM, SP-1 (Histotech) indicated the previous dermatologist would throw QC slides in the trash after review. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. 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 record review, lack of documentation, and interview, the laboratory failed to verify the accuracy of Mohs testing for one (2022) of two years reviewed. Findings included: 1. Review of "Quality Assurance Review", signed by laboratory director on 8/24/22, revealed peer-review was performed January 2022 to June 2022 on 8/24/22 for 23 Mohs cases. There was no documentation that peer-review was completed for Mohs cases the second half of 2022. 2. Review of the "Mohs Laboratory Procedure Manual", signed by laboratory director on 1/2/23, indicated the laboratory had no policy on how twice annual verification will be performed. 3. During an interview on 1 /31/2023 at 2:49 PM, SP-1 (Histotech) confirmed peer-review was not performed for the second half of 2022 for Mohs testing. 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, record review and interview, the laboratory failed to define and maintain temperatures for two (Leica CMS 1850 and Leica CMS 1860) of two cryostats in use for Mohs slides from October 2020 to January 2023. Findings include: 1. During tour of the laboratory on 1/31/23 at 11:18 AM, the following equipment was observed: Leica CMS 1850 Cryostat Machine and Leica CMS 1860 Cryostat Machine. 2. The manual "Leica CM1510S", version 08/2003, under 6.7 "Temperature selection chart required the following temperatures: a) Skin with fat -25 degrees Celsius (C) - -35 degrees C) Skin without fat -15 degrees C - 25 degrees C. 3. Review of policy "Cryostat Maintenance", signed by laboratory director on 1/2/23, read "If temperature is ever below -30 degree C or higher than -20 degree C