Phoenixville Valley Forge Dermatology Assoc

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: A Based on the review of the laboratory's peer review records, and interview with the Nurse Manager (NM), the laboratory failed to ensure that the verification of accuracy for microscopic examinations for histopathology (Mohs) was performed at least twice annually, as required for tests not included in subpart I for 1 of 1 year in 2024. Findings Include: 1. On the day of the survey, 11/13/2025 at 09:35 am, review of the laboratory's peer review records revealed the laboratory failed to ensure the verification of accuracy for histopathology slide examinations was performed at least twice annually for 1 of 1 year in 2024. 2. The laboratory performed 1,045 microscopic slide examinations (histopathology) in 2024 (CMS-116, estimated annual volume, dated 11/12/2025). 3. The NM confirmed the findings above on 11/13/2025 at 09:40 am B Based on policy review, lack of documentation, and interview with the Nurse Manager (NM), the laboratory failed to ensure that the verification of accuracy for 2 of 3 microbiology microscopic examinations was performed at least twice annually, as required for tests not included in subpart I from 11/07/2023 to date of survey. Findings include: 1. The laboratory's PEER Review/ Proficiency Policy states: Peer review will be performed for Scabies prep and KOH prep every 6 months." 2. On the day of the survey, 11/13/2025 at 9:00 am, the laboratory could not provide documentation that the verification of accuracy for 2 of 3 microbiology microscopic examinations (KOH and Scabies prep) were performed twice annually from 11/07 /2023 to date of survey. 3. The laboratory performed 26 microbiology slide examinations in 2024 (CMS 116, estimated annual volume, dated 11/12/2025). 4. The NM confirmed the findings above on 11/13/2025 at 09:15 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 3 -- 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 Nurse Manager (NM), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 Labomed CXL microscope, 1 of 1 Lecia DM 1000 microscope, 1 of 1 Bristoline Brisolscope and 1 of 1 Avantix QS-11 cryostat used to perform histopathology (Mohs) microbiology microscopic slide examinations from 11 /07/2023 to 11/13/2025. Findings include: 1. The manufacturers operating environment specifications stated the following: 5-40 degrees Celsius (ambient temperature); maximum 80 % relative humidity. 2. On the day of the survey, 11/13 /2025, the laboratory failed to provide documentation for the monitoring of room humidity to ensure operating conditions were met for the following instruments used to perform histopathology (Mohs) and microbiology microscopic examinations (scabies, KOH, dermatophyte screenings) from 11/07/2023 to 11/13/2025: - 1 of 1 Labomed CXL microscope - 1of 1 Lecia DM 1000 microscope - 10f 1 Bristoline Brisolscope -1 of 1 Avantix QS-11 cryostat 3. The laboratory performed 1,045 histopathology (Mohs) slide examinations and 26 microbiology (scabies, KOH dermatophyte screenings) slide examinations in 2024 (CMS 116, estimated annual volume, dated 11/12/2025). 4. The NM confirmed the above findings on 11/13/2025 at 09:30 am. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of the laboratory's competency policy, personnel competency records, CLIA laboratory personnel report (CMS 209), and interview with Nursing Manager (NM), the Technical Consultant (TC) (CMS 209 personnel #1) failed to evaluate the annual competency of 2 of 2 testing personnel (TP) who performed microbiology microscopic slide examinations from 11/07/2023 to 11/13/2025. Findings include: 1. The laboratory's Competency/Training Policy stated: "Competency/training will be completed by all test performing personnel prior to performing test for the first time. It will then be completed 6 months later and every year after that." 2. On the day of survey 11/13/2025 at 8:50 am, review of the laboratory's personnel competency records and CMS 209 form revealed the TC failed to evaluate the annual competency of 2 of 2 TP #2 and TP#3 (CMS 209 personnel #2 and #3, dated 11/12/2025) who perform microbiology slide examinations (Scabies and KOH prep) from 11/07/2023 to 11/13/2025. 3. The laboratory performed 26 -- 2 of 3 -- microbiology slide examinations in 2024 (CMS 116, estimated annual volume, dated 11/12/2025). 4. The NM confirmed the above findings on 11/13/2025 at 9:00 am. -- 3 of 3 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the Clinical Nurse Manager (CNM) the laboratory failed to ensure review and evaluation of the results obtained for 2 of 3 API PT events in 2022 and 3 of 3 API PT events in 2023 in Microbiology. Findings: 1. On the day of survey 11/07/2023 at 9:55 am review of API PT records revealed the Laboratory Director's (LD) review signature for PT score reports was missing for the following API Microbiology PT events: - Events #1 & #3 in 2022. - Events #1, #2 & #3 in 2023. 2. The laboratory could not provide documentation of evaluation & review performed on the 2022 and 2023 API Microbiology PT records. 3. Interview with CNM on 11/07 /2023 at 10:50am confirmed findings above. 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 and interview with the Clinical Nurse Manager (CNM), the laboratory failed to perform and document maintenance on the 1 of 1 thermometer for room temperature in Histopathology laboratory from 01/04/2022 to 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 -- date of survey. Findings Include: 1. On the day of survey, 11/07/2023 at 9:16am, during observation of the lab the surveyor discovered 1 of 1 Thomas Scientific Humidity and Temperature indicator with no expiration date or serial number. 2. There was no identifying label on the instrument. 3. The laboratory could not provide a maintenance documentation for the thermometer. 4. Interview with CNM on 11/07 /2023 at 10:50am confirmed the thermometer was used to record room temperature in the Histopathology laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D2043 MYCOLOGY CFR(s): 493.827(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency test records and personnel interview with the Nurse Manager, the Laboratory failed to participate in 1 of 3 American Proficiency Institute (API), 2020 events. for: Dermatophyte Identification (ID). findings include: Subspecialty Analyte Year Event Score Mycology Dermatophyte ID 2020 2 0% During the survey, (11:00 01/04/2022), the Nurse Manager confirmed the findings. D2044 MYCOLOGY CFR(s): 493.827(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency test records and personnel interview with the Nurse Manager, the Laboratory failed to satisfactorily participate in 1 of 3 American Proficiency Institute (API), 2021 events. for: Dermatophyte Identification (ID). findings include: Subspecialty Analyte Year Event Score Mycology Dermatophyte ID 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 -- 2021 2 60% During the survey, (11:00 01/04/2022), the Nurse Manager confirmed the findings. -- 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, testing personnel (TP) competency assessment documents and interview with a registered nurse (RN) and registered medical assistant (RMA), the laboratory failed to establish a complete competency assessment policy to assess the competency of 1 of 1 testing personnel (TP) who performed mohs microscopic examinations and 1 of 1 supervisor's competency from 10/13/2017 to the date of survey. Findings Include: 1. On the day of survey, 08/14/2019, the laboratory failed to provide a competency assessment policy to assess 1 of 1 TP who performed mohs microscopic examinations and 1 of 1 technical supervisors / general supervisor in 2017 or 2018. 2. The RN and RMA confirmed the findings above on 08/14/2019 around 09:15 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 --