Pa Dermatology Partners Ne Phlly

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 Director of training and compliance (DTC), 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 from 01/01/2024 to the date of the survey. Findings include: 1. On the day of survey, 03/11/2025 at 09:12 am, the laboratory the laboratory failed to provide documentation for the verification of accuracy performed for MOHS microscopic examinations at least twice annually from 01/01/2024 to 03/11 /2025. 2. The laboratory's proficiency testing policy states "Semi-annually, the tech or risk manager will send five cases containing the original slide and send out for a microscopic examination by a board certified Dermatopathologist". 3. The laboratory reported an annual volume of 1200 microscopic examinations/tests performed in Histopathology (CMS 116 estimated annual volume). 4. The DTC confirmed the above findings on 03/11/2025 at 09:12 am. ***** Repeat Deficiency***** 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 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 -- interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the Director of Training and Compliance (DTC), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Lecia DM 2000 Microscope used to perform histopathology slide examinations from 05/02/2023 to the date of survey. Findings include: 1. The operating environment listed in the instruction manual for the Lecia biological microscope states: "microscope should be kept at temperatures between 0C-40C/32F-104F, with a maximum humidity of 85%." 2. On the date of the survey, 03/11/2025 at 09:30 am, the laboratory failed to provide documentation for monitoring room temperatures and humidity to ensure operating conditions were met for 1 of 1 Lecia DM 2000 microscope used to perform histopathology slide examinations from 05/02/2023 to 03 /11/2025. 3. The laboratory performed 1200 (CMS-116 estimated annual volume) histopathology slide examinations in 2024. 4. The DTC confirmed the findings above on 03/11/2025 at 09:30 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 peer review records and interview with the Laboratory Manager (LM), the laboratory failed to perform at least twice annually the accuracy of Mohs micrographic examinations for 1 of 1 testing personnel (TP) in 2021, 2022 and 2023. Finding Include: 1. On the day of survey, 05/02/2023 at 10:38 am, review of Mohs micrographic examinations peer review records revealed that the evaluation and verification activity was performed once in 2022. 2. Further review of Mohs micrographic examinations peer review records showed that the laboratory did not clearly record who was the assessed pathologist and who was the reviewer for the Mohs micrographic examinations in July 2021, January 2022 and January 2023. 3. The laboratory's annual volume for histopathology is 600 patient examinations (CMS 116 form). 4. The LM confirmed the findings above on 05/02/2023 around 11:00 am. 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 the observation of the laboratory and interview with the laboratory manager (LM), the laboratory failed to ensure that 3 of 5 bottles of Avantik tissue marking dyes 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 -- were not used beyond their expiration date from 05/2020 to the day of survey. Finding include: 1. On the day of survey, 05/02/2023 at 11:12 am, observation of the laboratory revealed that the following 3 of 5 bottles of Avantik tissue marking dyes were expired: - Blue Avantik tissue marking dye bottle, Lot# 0066596 - Expired: 05 /2020. - Yellow Avantik tissue marking dye bottle, Lot# 066896 - Expired: 05/2020. - Black Avantik tissue marking dye bottle, Lot# 067444 - Expired: 06/2020. 2. The LM confirmed the finding above on 05/02/2023 around 11:10 am 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 of the microscope and interview with laboratory manager (LM), the laboratory failed to perform maintenance on 1 of 1 microscope from 07/2021 to 05 /02/2023. Findings Include: 1. On the day of survey, 05/02/2023 at 11:18 am, observation of the microscope revealed that 1 of 1 microscope was due for maintenance on 07/2021. 2. The last calibration for the microscope was on 04/03 /2020. 3. The laboratory did not provide maintenance records for the microscope for 2021 and 2022. 4. The LM confirmed the findings above on 05/02/2023 around 11:10 am -- 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, review of manufacturer's instructions, and personnel interview of the Histotechnologist and Mohs Technologist on the date of the survey (10/30 /2018), the Laboratory failed to follow manufacturer's instructions for storage of AcuDTM media, from 04/24/2017 through 10/30/2018. Findings include: 1. AcuDTM media is to be stored at 36 - 46 Fahrenheit (F) according to the manufacturer's instructions. 2. At the time of the survey (10:00 10/30/2018) the laboratory failed to document temperature of the refrigerator used for media. 3. The refrigerator used for media had 2 lots of AcuDTM media: Lot D 1255-117 (4 vials) Expiration date 19/11 /28 Lot DR 90-0918 (96 vials) Expiration date 20/09/04 4. During the survey the Histotechnologist confirmed the above findings. 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 --