John K Wildemore Md, Llc

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 Testing Personnel (TP) #2, the laboratory failed to verify twice annually the accuracy of macroscopic histopathology examinations performed for 2 of 2 years in 2024 and 2025. Findings include: 1. On the day of survey, 11/13/2025, the laboratory failed to provide documentation for the verification of accuracy performed at least twice annually for macroscopic histopathology examinations (grossing and inking) performed in 2024 and 2025. 2. The laboratory could not provide a procedure for the performance of the verification of accuracy for macroscopic histopathology examinations (grossing and inking). 3. TP #2 (CMS 209 personnel #2, dated 11/13/2025) confirmed the findings above on 11/13 /2025 at 10:50 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 the laboratory's temperature records, lack of documentation, and interview with Testing Personnel (TP) #2, the laboratory failed to establish acceptable criteria for relative humidity to ensure operating conditions were met for reliable test system operation and test result reporting of MOHS microscopic slide examinations performed for 2 of 2 years from 11/02/2023 to 11/13/2025. Findings Include: 1. On the day of the survey, 11/13/2025 at 09:43 am, review of the laboratory's temperature logs revealed the laboratory failed to establish acceptable criteria for relative humidity to ensure operating conditions were met for the following instrumentation used when Mohs microscopic slide examinations were performed from 11/02/2023 to 11/13 /2025: - Avantik QS11 cryostat (s/n 57840) manufacturer's acceptable range: 0% to 60% - Leica DM 750 microscope (s/n 29VP0086) manufacturer's acceptable range: 20% to 90% 2. The laboratory could not provide documentation of monitoring relative humidity for 2 of 2 years when Mohs microscopic examinations were performed from 11/02/2023 to 11/13/2025. 3. Review of the laboratory's Mohs test logs revealed the laboratory performed 473 histopathology slide examinations from 11/02/2023 to 11/13 /2025. 4. TP #2 (CMS 209 personnel #2, dated 11/13/2025) confirmed the findings above on 11/13/2025 at 10:50 am. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of maintenance/function check records and interview with Testing Personnel (TP) #2, the laboratory failed to assess the maintenance and function checks as defined by the manufacturer for 1 of 1 Extech thermometer/humidity monitor used in the Histopathology laboratory from 11/02 /2023 to the day of survey. Findings Include: 1. On the day of survey, 11/13/2025 at 10:22 am, observation of the laboratory revealed 1 of 1 Extech hygro-thermometer clock (model number 445703), with no expiration date. 2. The laboratory could not provide maintenance/function check records for the 1 of 1 Extech thermometer /humidity monitor used to record room temperature in the Histopathology laboratory from 11/02/2023 to 11/13/2025. 3. TP #2 (CMS 209 personnel #2, dated 11/13/2025) confirmed the findings above on 11/13/2025 at 10:50am. -- 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 the laboratory's procedure manual and interview with testing personnel #2 (TP), the laboratory failed to establish a procedure that includes the six points of CLIA for the assessment of 1 of 2 testing personnel (TP) that performed inking of histopathology specimens from 03/16/2022 to the date of survey. Findings include: 1. On the day of survey, 11/01/2022 at 09:35 am, the laboratory could not provide a competency assessment policy that includes the minimum requirements of CLIA to assess 1 of 2 TP (CMS 209 TP #2) that performed inking of histopathology exmainations from 03/16/2022 to 11/02/2023. 2. The laboratory performed 473 histopathology examinations in 2022 (CMS 116 annual volume). 3. TP #2 confirmed the finding above on 11/01/2022 at 10:30 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 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the histology technology (HT), the laboratory failed to have safety data sheets (SDS) accessible to ensure protection from physical, chemical, biochemical, and biohazardous reagents and stains store in the laboratory from 2017 to the date of survey. Findings Include: 1. On the day of survey, 11/08/2019, the HT could not provide SDS to ensure protection from physical, chemical, biochemical, and biohazardous reagents and stains for the list below from 12/22/2017 to 11/08/2019. - Avantik Biogroup, 95% reagent alcohol. - Avantik Biogroup, 100% reagent alcohol. - Avantik Biogroup, scotts tap water. - Avantik Biogroup, eosin working solution. - Avantik Biogroup, hematoxylin gills III stain. - Avantik Biogroup, tissue marking dye (red). - Avantik Biogroup, tissue marking dye (yellow). - Avantik Biogroup, tissue marking dye (blue). 2. The HT confirmed the findings above on 11/08/2019 around 10:15 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. 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 -- This STANDARD is not met as evidenced by: Based on observation of reagents and interview with the histology technologist (HT), the laboratory failed to label and indicate reagents and stains with the appropriate open dates and other pertinent information required for proper use in 2017 to the date of survey. Findings Include: 1. On the day of survey, 11/08/2019, observation of reagents and stains in use, revealed that the laboratory did not record open dates of the following reagents and stains below: - 1 of 1, gallon bottle of Avantik Biogroup, 95% reagent alcohol. - 1 of 1, gallon bottle of Avantik Biogroup, 100% reagent alcohol. - 1 of 1, gallon bottle of Avantik Biogroup, scotts tap water. - 1 of 1, 32 oz bottle of Avantik Biogroup, eosin working solution. - 1 of 1, 32 oz bottle of Avantik Biogroup, hematoxylin gills III stain. - 2 of 2, 2 oz bottle of Avantik Biogroup, tissue marking dye (red). - 1 of 1, 2 oz bottle of Avantik Biogroup, tissue marking dye (yellow). - 1 of 1, 2 oz bottle of Avantik Biogroup, tissue marking dye (blue). 2. The laboratory was unable to provide pertinent information regarding 1 of 1 bottle of unlabeled solution, thought to be Toluidine blue stain. 3. The HT confirmed the findings above on 11/08/2019 around 10:00 am. *** oz = Ounce 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 laboratory reagents and interview with the histotechnologist (HT), the laboratory failed to ensure that Avantik Biogroup, tissue marking dyes (2 of 5 bottles) were not used beyond their expiration date. Finding Include: 1. On the day of survey, 11/08/2019, observation of laboratory reagents revealed, the below Avantik Biogroup, tissue marking dyes (2 of 5 bottles) had expired in 2017: - Avantik Biogroup, tissue marking dye (red), Lot# 42664, Expired: 10/2017. - Avantik Biogroup, tissue marking dye (yellow), Lot#042825 , Expired: 10/2017. 2. The HT confirmed the finding above on 11/08/2019 around 10:00 am. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, maintenance records and interview histology technologist (HT), the laboratory failed to document the maintenance activities specified in their procedure manual for 1 of 1 Leica DM 750 microscope used for mohs microscopic examination in 2018. Findings Include: 1. -- 2 of 3 -- According to the Laboratory's microscope maintenance policy signed by the Laboratory Director, " 3. Yearly preventive maintenance done by approved microscope company." 2. On the day of survey, 11/08/2019, the laboratory could not provide documentation regarding preventive maintenance performed on 1 of 1 Leica DM 750 microscope in 2018. 3. In 2018, 300 patient slides were analyzed. 3. The HT confirmed the findings above on 11/08/2019 around 9:30 am. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on the review of patient test reports and interview with histology technologist (HT), the laboratory failed to include on mohs maps/test reports (2 of 2 reviewed) the location where mohs microscopic examination slides were read from 12/22/2017 to the date of survey. Finding Include: 1. On the day of survey, 11/08/2019, review of some test reports (2 of 2 reviewed), revealed that the test reports did not include the address where mohs microscopic examination slides were being read from 12/22/2017 to 11/08/2019. 2. In 2018, 300 patient slides were analyzed. 3. The HT confirmed the location where mohs microscopic examination slides were read are not included on mohs maps/test reports on 11/08/2019 around 10:30 am. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the mohs microscopic examination procedure manual and interview with the histology technologist (HT), the laboratory director failed to ensure an approved procedure manual was available for mohs microscopic examination from 2017 to the date of survey. Findings Include: 1. On the day of survey, 11/08/2019, review of the mohs microscopic examination procedure manual revealed, the manual listed a different laboratory name (Main Line Dermatology) than the laboratory being inspected (John K. Wildemore MD, LLC). 2. The surveyor was unable to distinguish if the mohs microscopic examination procedure was from the laboratory being inspected, or from another laboratory. 3. The HT confirmed the findings above on 11 /08/2019 around 9:35 am. -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --