St Luke's Mohsmicrographicsurgery

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 lack of documentation and interview with the Medical Technologist (MT), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Olympus BX46 microscope used to perform histopathology microscopic slide examinations from 11/01/2025 to 01/30 /2026. Findings include: 1. The manufacturers operating environment specifications stated, " Olympus BX46 microscope: 5-40 degrees Celsius (ambient temperature); maximum 80 % relative humidity." 2. On the day of the survey, 01/30/2026 at 10:45 am, the laboratory failed to provide documentation for the monitoring of room temperature and humidity to ensure operating conditions were met for the following instruments used to perform histopathology microscopic examinations from 11/01/25 to 01/30/2026: - 1 of 1 Olympus BX46 microscope 3. The laboratory performed 2,414 histopathology slide examinations in 2025 (CMS 116, estimated annual volume, dated 12/22/2025). 4. The MT confirmed the findings above on 1/30/2026 at 10:45 am. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manuals and interview with the Histotechnologist (HT), the laboratory failed to establish a competency assessment procedure to assess 1 of 2 Clinical Consultants (CC) for their supervisory responsibilities from 7/23/2020 to the day of survey. Findings Include: 1. On the day of survey, 07/14/2022 at 09:05 am, the laboratory could not provide a competency assessment procedure to assess the competency for 1 of 2 CC (CMS 209 Personnel #2) from 7/23/2020 to 07/14/2022. 2. The HT could not provide competency assessment documentation for 1 of 2 CC from 07/23/2022 to 07/14/2022. 3. The HT confirmed the findings above on 07/14/2022 around 10:15 am. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory competency assessment records and interview with 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 Histotechnologist (HT), the Technical Supervisor (TS) failed to evaluate the annual competency assessment for 1 of 3 Testing Personnel (TP) who performed MOHS Micrographic surgery slides examined from 12/19/2020 to the day of survey. Findings include: 1. On the day of survey 07/14/2022 at 09:05 am, the HT could not provide competency assessment record for 1 of 3 TP (CMS 209 personnel #2) who performed MOHS Micrographic surgery slide examinations from 07/23/2020 to the day of survey. 2. The laboratory performed 2,824 MOHS Micrographic surgery slide examinations in 2021. 3. The HT confirmed the findings above on 07/14/2022 around 10:15am. -- 2 of 2 --