Philadelphia Center For Dermatology

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 review of laboratory records, lack of documentation, and interview with the Laboratory Director (LD) and the Practice Manager (PM), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Lecia DBLB30T Microscope used to perform histopathology slide examinations from 04/26/2023 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, 02/28/2025 at 09:40 am, the laboratory failed to provide documentation for monitoring room temperatures and humidity to ensure operating conditions were met for 1 of 1 Lecia DBLB30T microscope (s/n 241029) used to perform histopathology slide examinations from 04/26/2023 to 02/28/2025. 3. The laboratory performed 361( CMS- 116) histopathology slide examinations from 04/26/2023 to 02/28/2025. 4. The LD confirmed the findings above on 02/28/2025 at 10:15 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 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 laboratory procedures, Potassium Hydroxide (KOH) Control and Assessment Form, Proficiency Testing (PT) records and interview with the Laboratory Director (LD) and Practice manager (PM), the laboratory failed to verify the accuracy of KOH and Scabies microscopic examinations at least twice annually in 2021 and 2022. Findings Include: 1) On the day of the survey, 04/26/2023 at 12: 39pm, the laboratory could not provide more than one PT record for KOH and Scabies microscopic examinations in 2021 and 2022. 2) Interview with the PM revealed the PT was performed through peer review and he was under the impression that PT only needed to be completed twice during the first year of testing and then yearly after that. 3) The laboratory's procedure states that proficiency testing for KOH and Scabies is performed once a year. 4) The LD and PM confirmed the above findings on 04/26/2023 around 12:45pm. 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. 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 Histology Room Temperature & Humidity records and interview with the Laboratory Director (LD), the lab failed to document room temperature and humidity in histology for 9 of 12 months in 2021. Findings Include: 1) On the day of the survey 04/26/2023 at 1:55pm, review of the 2021 Histology Room Temperature and Humidity Log revealed no temperature or humidity readings were recorded from April 18, 2021 through December 31st, 2021. 2) The LD confirmed finding above on 04/26/2023 around 2:00pm. -- 2 of 2 --

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, interview with laboratory director (LD) and coordinator, the laboratory failed to establish a complete competency assessment procedure to assess 1 of 2 testing personnel (TP) who performed Potassium Hydroxide (KOH) and scabies microscopic examinations from September of 2020 to the day of survey. Findings include: 1. On the day of survey, 04/15/2021, the laboratory could not to provide a complete competency assessment procedure to assess the competency of 1 of 2 TP performing KOH and scabies microscopic examinations in 2020 and 2021. 2. The LD could not provide training or the 6 month competency records for TP#2 analyzing KOH and scabies microscopic examinations from September 2020 to April 2021. 3. The LD and coordinator confirmed the findings above on 04/15/2021 around 09:20 am. 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 Laboratory director (LD) and coordinator, the laboratory failed 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 -- to ensure 2 of 2 Testing personnel (TP) performed in the verification of accuracy at least twice annually for Mohs and scabies microscopic examinations in 2019 and 2020. Findings Include: 1. On the day of survey, 04/15/2021, the laboratory could not provide verification of accuracy performed at least twice annually for the following tests in 2019 and 2020: - Mohs microscopic examination for 1 of 2 TP (TP#1). - Scabies microscopic examination for 2 of 2 TP. 2. The LD and coordinator confirmed the findings above on 4/15/2021 around 10:00 am. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of tissue inking dyes in use, review of the laboratory procedure manual and interview with the laboratory director (LD) and coordinator, the laboratory failed to label 5 of 5 - 56 ml bottles of Thermo Scientific Shandon Tissue Marking dyes to indicate their open and expiration dates. Findings include: 1. The laboratory procedure manual, under QC/QA Procedures for Histology on Frozen Sections, quality control, 3. Test methods, Equipment, Reagents, Material and Supplies, 3.5 - "All reagents, solutions, culture media, control material, calibration material and others supplies will be labeled to indicates": 3.5.3 states, "Received, open and check expiration date". 2. On the day of survey, 04/15/2021, observation of the laboratory's tissue marking dyes revealed 5 of 5 - 56 ml bottles of Thermo Scientific Shandon Tissue Marking dyes in use, did not indicate open or expiration dates: - Red - Reference #3120127 - Lot#714046. - Blue - Reference #3120124 - Lot#714146. - Yellow - Reference #3120126 - Lot#710919. - Black - Reference #3120125 - Lot#714006. - Green - Reference #3120128 - Lot#709344. 3. The LD and coordinator confirmed the findings above on 04/15/2021 around 9:40 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 laboratory microscopes and interview with the laboratory director (LD) and coordinator, the laboratory failed to perform maintenance /calibration for 2 of 2 microscopes used to analyze Mohs, Potassium Hydroxide (KOH) and scabies microscopic examinations from 02/2020 to the day of survey. Findings include: 1. The Laboratory Procedure Manual, under section 5 Quality assurance/ quality control, Quality Control, 7. Equipment quality control, 7.1 Microscopy, 7.1.4. states, "All microscopes are tested, calibrated and aligned by Micronix Systems Yearly." 2. On the day of survey, 04/15/2021, observation of microscopes used to analyze Mohs, KOH and scabies microscopic examinations -- 2 of 3 -- revealed the following microscopes were due for calibration on February of 2020: - Nikon Eclipse Ci - Serial #951210. - Lecica DMLB - Serial #241029. 3. The laboratory was unable to provide documentation of calibration performed on 2 of 2 microscopes after February of 2020. 4. The LD and coordinator confirmed the findings above on 4/15/2021 around 9:50 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, interview with the Laboratory director (LD) and coordinator, the LD failed to ensure quality assessment (QA) programs were established and documented to assure the quality of laboratory services provided from 2019 to the day of survey. Findings Include: 1. On the date of survey, 04/15/2021, the LD could not provide a complete QA procedure or documentation of periodic evaluation of the laboratory, that assess the laboratory's pre analytical, analytical, and post analytical processes from April 15, 2019 to April 15, 2021. 2. The LD and coordinator confirmed the finding above on 4/15/2021 around 9: 30 am. -- 3 of 3 --