Pinnacle Dermatology

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation, record review and interview with the histotechnician (HT), the laboratory failed to label 1 of 12 bottles of frozen embedding medium with an open date. Findings include: 1. During a tour of the laboratory on 2/11/2026 at 9:15 am, the surveyor observed one bottle of Polarstat Plus embedding medium, lot number 215034, with an expiration date of 11/30/2026 which was not labeled with an open date. 2. A review of the laboratory policy, titled "POLICY ON QUALITY ASSURANCE AND PROCEDURE -MOHS SURGERY", paragraph d., "Storage and handling," iv., reveals "Reagents will have date received, date opened, and expiration date listed on them." 3. On 2/11/2026 at 9:20 am, an interview with the HT confirmed that the bottle of frozen embedding medium was not labeled with an open date in accordance to the laboratory's policy. D5805 TEST REPORT CFR(s): 493.1291(c) (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 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 -- 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 record review and interview with the histotechnician (HT), the laboratory failed to document the correct surgery date on the patient Mohs map for 1 (P6) of 10 patient test reports reviewed. Findings include: 1. On 2/11/2026 at 10:00 am, a request was made to review Mohs maps, Hematoxylin and Eosin (H&E) tissue slides, patient visit notes, and pathology reports for 10 patients (P1, P2, P3, P4, P5, P6, P7, P8, P9, and P10). 2. A review of patient #6 (P6) Mohs map, patient operative report, and the Mohs laboratory log revealed inconsistencies in documentation, as follows: a. The Mohs laboratory log revealed a specimen collection date of 6/25/2025. b. The patient operative note revealed a Mohs surgery date of 6/25/2025. c. The Mohs map report revealed a surgery date of 7/25/2025. 3. On 2/11/2026 at 1:00 pm, during an interview, the HT confirmed that the surgery for P6 was performed on 6/25/2025 and acknowledged that the Mohs map report reflected an incorrect surgery date of 7/25 /2025. -- 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 Moh's Supervisor (MS), the laboratory failed to verify the accuracy of its microscopic tissue examination testing at least twice annually for 1 (2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's verification of accuracy documentation revealed a lack of documentation for 1 (2021) of 2 years reviewed. 2. An interview on 3/31/2022 at 8:55 am, the MS confirmed the verification of accuracy testing for its microscopic tissue examinations was not completed in 2021. 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 Mohs' Supervisor (MS), the laboratory failed to maintain a record system that included the specimen receipt time into the laboratory for each stage of the Mohs' tissue specimens for 7 of 13 Mohs' 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 -- patient charts audited. Findings include: 1. Record review for 7 of 13 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. OPM21 - 0006 performed on 1/26/2021 b. OPM21 - 0124 performed on 5 /25/2021 c. OPM21 - 0162 performed on 7/28/2021 d. OPM21-0026 performed on 9 /13/2021 e. OMS21-0090 performed on 11/08/2021 f. OMS21 - 0010 performed on 1 /03/2022 g. OMS22-0090 performed on 3/14/2022 2. During the interview on 3/31 /2022 at 10:12 am, the MS confirmed the recording of the specimen receipt time into the laboratory for processing was not present on the Mohs' map. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on document review and interview with the Mohs' Supervisor (MS), the laboratory failed to establish a system to ensure the transcribed Mohs' surgery site were accurately reported for 7 of 13 Mohs' cases reviewed. Findings include: 1. Record review revealed for 7 of 13 Mohs' cases reviewed, the Mohs' surgical site on the pre-op biopsy report, the Mohs' map, the Mohs' log did not match the location on the final report in the LIS system as follows: a. OPM20-0206 performed on 12/15 /2020 i. Pre-op biopsy report and the Mohs' map - left central postauricular skin ii. Mohs' log and LIS report - left central postauricular b. OPM21-0006 performed on 1 /26/2021 i. Pre-op biopsy report and the LIS report - left proximal pretibial region ii. Mohs' map and Mohs' log - left proximal pretibial c. OPM21-0055 performed on 3/30 /2021 i. Pre-op biopsy report, Mohs' map, and the Mohs' log - right lateral eyebrow ii. LIS report - right inferior lateral forehead d. OPM21-0162 performed on 7/28/2021 i. Pre-op biopsy report and Mohs' map - right superior crus of antihelix ii. Mohs' log - right superior crus of helix iii. LIS report - right inferior posterior helix e. OMS21- 0026 performed on 9/13/2021 i. Per-op biopsy report, Mohs' map, and Mohs' log - right lateral trapezial neck ii. LIS report - right medial trapezial neck f. OMS21-0010 performed on 1/03/2022 i. Pre-op biopsy report and the LIS report - left distal pretibial region ii. Mohs' map and Mohs' log - left distal pretibial g. OMS22-0090 performed on 3/14/2022 i. Pre-op biopsy report and LIS report - right distal pretibial region ii. Mohs' map and Mohs' log - right distal pretibial 2. An interview on 3/31 /2022 at 10:15 am, the MS confirmed the locations on the pre-op biopsy report, Mohs' map, Mohs' log and the final LIS report were not consistent with the original tumor site. -- 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 record review and interview with Testing Personnel #2 (TP2), the laboratory failed to follow policies to assess competency of 3 (Testing Personnel #3, #4, and #6) of 6 testing personnel listed on the CMS-209 form. Findings include: 1. A review of testing personnel competency assessments revealed a lack of documentation for the following testing personnel performing high-complexity histopathology testing listed on the CMS-209 form: a. Testing Personnel #3 b. Testing Personnel #4 c. Testing Personnel #6 2. A review of the laboratory's established "Quality Assessment Procedures" policy revealed a section stating, "The competency of Test Personnel and all staff members will be evaluated and documented every year by the Laboratory Director or an appropriate, designated staff member and every six months for the first year of training to ensure that all laboratory staff maintains their competency in testing and laboratory management function. Proper training will be provided to correct and deficiencies found." 3. An interview on 3/11/2020 at 10:15 am with TP2 confirmed the competency assessments for the testing personnel listed above were not 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 --

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 --