Base Of The Bays Dermatology, Pc

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 record review and interview with the laboratory director, the laboratory failed to follow competency assessment policies to ensure testing personnel were competent to perform Potassium Hydroxide (KOH) preparations for one (2024) of two years reviewed. Findings include: 1. A review of the laboratory's Form CMS-209 revealed the laboratory director serves all regulatory roles for the laboratory and is the only testing personnel. 2. A review of the laboratory's "Potassium Hydroxide (KOH) Examination" policy revealed a section titled "Quality Control" stating, "The laboratory director will maintain proficiency by completing testing by the Michigan Dermatological Society twice yearly." 3. A review of the testing personnel's Michigan Dermatological Society Provider-Performed Microscopy assessments revealed a lack of assessments performed in 2024. 4. An interview on 12/18/25 at 2:45 pm with the laboratory director confirmed Michigan Dermatological Society Provider-Performed Microscopy assessments were not performed in 2024. 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: 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 -- . Based on record review and interview with the laboratory director, the laboratory failed to verify the accuracy of its Potassium Hydroxide (KOH) preparation testing at least twice annually for one (2024) of two years reviewed. Findings include: 1. A review of the laboratory's "Potassium Hydroxide (KOH) Examination" policy revealed a section titled "Quality Control" stating, "The laboratory director will maintain proficiency by completing testing by the Michigan Dermatological Society twice yearly." 2. A review of the testing personnel's Michigan Dermatological Society Provider-Performed Microscopy assessments revealed a lack of assessments performed in 2024. 3. An interview on 12/18/25 at 2:45 pm with the laboratory director confirmed Michigan Dermatological Society Provider-Performed Microscopy assessments were not performed in 2024. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) 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. (b)(1)(ii) 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 observation, record review, and interview with the laboratory director, the laboratory failed to perform microscope maintenance in accordance with the laboratory's established maintenance protocol for two (December 2023 to December 2025) of two years reviewed. Findings include: 1. The surveyor observed the laboratory's microscope on 12/18/25 at 1:10 pm. The microscope had a sticker from "Toby's Inst. Shop INC" with the date serviced of 10/27/21. 2. A review of the laboratory's "Equipment Quality Control- Microscope" policy revealed a section stating, "Microscope stage and ocular eye pieces are to be cleaned every six months. Annually by Toby's." 3. A review of the laboratory's "Maintenance Record- Microscope" revealed the last date the microscope was cleaned by the laboratory was 10/16/24. 4. A review of the laboratory's invoice from Toby's Instrument Shop Inc confirmed the last annual service was performed on 10/27/21. 5. An interview on 12 /18/25 at 2:36 pm with the laboratory director confirmed the above findings. -- 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 record review and interview with the Laboratory Director, the laboratory failed to verify the accuracy of its Mohs surgery tissue examination testing at least twice annually for 2 (2022 and 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's "American Society for Mohs Surgery Peer Review Results (ASMS)" revealed a lack of documentation for the verification of accuracy testing for Mohs surgery cases was not performed twice annually for 2 (2022 and 2023) of 2 years as follows: a. ASMS performed 4/24/2022 - no documentation for July- December 2022. b. ASMS performed 12/28/2023 - no documentation for January - June 2023. 2. An interview on 1/16/2024 at 12:15 pm, the Laboratory Director confirmed verification of accuracy testing was not performed twice annually. ***Repeat Deficiency from 3/02/2020 survey*** D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 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 -- . Based on record review and interview with the Laboratory Director, the laboratory failed to receive documentation from the processing site for the daily Hematoxylin and Eosin (H&E) stain quality for its histopathology dermatology tissue specimens for 3 (#11, #15, and #19) of 19 patient records reviewed. Findings include: 1. A review of the H&E stain quality documents received from the processing laboratory on 1/16 /2023 at 12:09 pm revealed a lack of documentation for 3 of 19 patient records reviewed as follows: a. Patient #11 performed on 6/1/2022 - no H&E stain quality documentation. b. Patient #15 performed on 4/11/2023 - no H&E stain quality documentation. c. Patient #19 performed on 12/5/2023 - no H&E stain quality documentation. 2. An interview on 1/16/2023 at 2:30 pm, the Laboratory Director confirmed the laboratory was missing the processing site H&E stain quality for the dates listed above. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: . . Based on record review and interview with the Laboratory Director, the laboratory failed to document time of histopathology Mohs tissue specimen receipt into the laboratory for 3 (Patients #2, #3, and #8) of 19 patient test records reviewed. Findings include: 1. A record review of patient Mohs' maps revealed a lack of documented time of specimen receipt into the laboratory for 3 (Patient #2, #3, and #8) of 19 patient records reviewed as follows: a. Patient #2 testing performed on 7/17/2022 - no stage II receipt time. b. Patient #3 testing performed on 9/17/2022 - no stage II receipt time. c. Patient #8 testing performed on 9/23/2023 - no stage II receipt time. 2. An interview on 1/16/2024 at 2:30 pm, the Laboratory Director confirmed the patients listed above did not have the time of specimen receipt into the laboratory documented for stage II. -- 2 of 2 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to maintain a record system that included the specimen receipt time into the laboratory for each stage of the Mohs' tissue specimen for 2 (SJ20-364095 and TS21- 24702) of 11 Mohs' patient charts audited. Findings include: 1. Record review for 2 of 11 Mohs' cases reviewed, the laboratory failed to include the specimen receipt time into the laboratory for each stage of the Mohs' tissue specimen recorded on the final Mohs' map as follows: a. SJ20-364095 performed on 4/13/2020 stage I and II b. TS21- 24702 performed on 12/10/2021 stage I and II 2. During the interview on 3/21/2022 at 3:13 pm, the LD confirmed the specimen receipt times were not present on the Mohs' map. 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 record review and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of histopathology testing at least twice annually for 2 (2018 and 2019) of 2 years. Findings include: 1. A review of the laboratory's "American Society for Mohs Surgery Peer Review Results" revealed verification of accuracy testing for mohs surgery cases was only performed once in both 2018 and 2019. 2. An interview on 3/2/2020 at 11:36 am with the LD confirmed verification of accuracy testing was not performed twice annually. 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 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 --