Center For Skin Surgery Pc Lab,The

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 lack of documentation and interview with the Histotechnician (HT) and Laboratory Director (LD), the laboratory failed to ensure that the verification of accuracy for MOHS microscopic examinations were performed at least twice annually, as required for 1 of 1 test not included in subpart I for 2023 and 2024. Findings include: 1. On the day of survey, 05/14/2025 at 09:00 am, the laboratory failed to provide documentation for the verification of accuracy performed for MOHS microscopic examinations at least twice annually for 2023 and 2024. 2. The laboratory reported an annual volume of 450 MOHS microscopic examinations in 2024 (CMS 116 estimated annual volume). 3. The LD confirmed the above findings on 05/14 /2025 at 09:30 am. 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. 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 review of laboratory records, lack of documentation, and interview with the Histotechnician (HT) 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 slide examinations from 05/09/2023 to the date of survey. Findings include: 1. The operating environment listed in the instruction manual for the Olympus biological microscope states: "microscope should be kept at temperatures between 5C-40C/41F-104F, with a maximum humidity of 80%." 2. On the date of the survey, 05/14/2025 at 09:00 am, the laboratory failed to provide documentation for monitoring room temperatures and humidity to ensure operating conditions were met for 1 of 1 Olympus BX46 microscope used to perform histopathology slide examinations from 05/09/2023 to 05/14/2025. 3. The laboratory performed 450 (CMS-116 estimated annual volume) histopathology slide examinations in 2024. 4. The HT confirmed the findings above on 04/03/2025 at 10: 00 am. -- 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 review of the laboratory procedure manual, review of peer review records and interview with the histotechnician (HT), the laboratory failed to perform twice annual verification of accuracy for tissue pathology microscopic examinations in 2019. Findings Include: 1. On the day of survey, 06/16/2021, the laboratory could not provide twice annual verification of accuracy performed for tissue pathology microscopic examinations in 2019. 2. The Laboratory could not provide a policy for the performance of twice annual verification of accuracy for tissue pathology microscopic examinations. 3. The HT confirmed the findings above on 6/16/2021 around 01:10 pm. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the histotechnician (HT), the laboratory failed to ensure that 2 of 4 bottles of tissue marking dyes were not used beyond their expiration date. Finding Include: 1. On the day of survey, 06/16/2021, observation of the laboratory revealed, 2 of 4 Cancer Diagnostic Inc. (CDI) tissue 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 -- marking dyes were expired: - Green CDI bottle, Batch Code: 4204 - Expired: 2016 /01. - Black CDI bottle, Lot# 7172 - Expired: 2018/09. 2. The HT confirmed the findings above on 06/16/2021 around 13:50 pm. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, lack of documentation and interview with the histotechnician (HT), the laboratory failed to document maintenance for 1 of 1 room temperature thermometer from 05/12/2018 to 06/16/2021. Findings include: 1. On the day of survey, 06/16/2021, observation of the laboratory revealed, 1 of 1 Fisher Scientific Traceable min/max thermometer monitoring the room temperature, service sticker stated, "Due 05/12/2018". 2. The laboratory could not provide a maintenance procedure for the room temperature thermometer. 3. The HT confirmed the findings about on 06/16/2021 around 1:50 pm. -- 2 of 2 --