Skin Cancer And Dermatology Center, The

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: A. Based on observation and interview with the Mohs Tech (MT), the laboratory failed to calibrate one thermometer used to monitor a freezer in the laboratory. Findings include: 1. During a tour of the laboratory on 08/27/2025 at 11:20 am, the surveyor observed the freezer thermometer used to monitor frozen biopsies, with a calibration due date of 08/10/2024. 2. During an interview on 08/27/2025 at 11:20 am, the MT confirmed the freezer thermometer had not been calibrated as required. B. Based on observation and interview with the Mohs Tech (MT), the laboratory failed to ensure accurate readings of the room temperature thermometer in the laboratory. Findings include: 1. During a tour of the laboratory on 08/27/2025 at 11:20 am, the surveyor observed a room temperature thermometer in use without any indication that its accuracy had been verified. 2. During an interview on 08/27/2025 at 11:20 am, the MT stated there was no process to verify the accuracy of the room temperature thermometer and indicated she relied on her "feeling" of the room temperature rather than documented verification. 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 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD) and the Mohs' Technician (MT), the laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to follow its procedure for proficiency testing. Refer to D5401 B. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: A. Based on record review and interview with the Mohs' Technician (MT), the laboratory failed to follow its procedure for the "CLIA Regulations / Manual" for 17 (March 2022 to August 2023) of 17 months the manual was in use. Findings include: 1. A record review of the "Mohs' Procedure Manual" revealed the manual was signed 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 -- on 11/11/2019. 2. A review of the "CLIA Regulations / Manual" procedure states "The manual must be reviewed / updated annually. The Laboratory Director must document any reviews / updates." 3. A record review revealed for 17 (March 2022 to August 2023) of 17 months the "Mohs' Procedure Manual" was in use a lack of documentation of the annual review by the Laboratory Director. 4. An interview on 8 /28/2023 at 11:25 am, the MT confirmed the 'Mohs Procedure Manual" was not reviewed annually for 17 months. B. Based on observation, record review, and interview with the Laboratory Director (LD), the laboratory failed to follow its procedure for proficiency testing for 2 (M22-460 and M23-169) of 6 cases reviewed. Finding include: 1. The surveyor observed the laboratory was performing proficiency testing every 6 months by sending out 2 cases to be reviewed by an outside "Board Certified Dermatopathologist." 2. A record review of the proficiency testing cases revealed for 2 (M22-460 and M23-169) of the 6 cases, the returned diagnosis by the referring physician showed "positive for tumor" while the in-house showed negative. 3. A review of the Proficiency Testing "Mohs Micrographic Surgery Skin Specimen" procedure states "Upon receipt of the pathology report from the Dermatopathologist, diagnosis of the slide specimen will be matched to the in-house diagnosis by the physician. If the diagnoses match, the reports are attached and placed in the "Proficiency Testing" located in the quality control manual. In the event the pathology report from the Dermatopathologist does NOT match the in-house diagnosis by the physician, an identical slide will be sent, by the tech or risk manager to another outside laboratory chose from the list below, for microscopic examination." 4. An interview on 8/28/2023 at 1:58 pm, the LD confirmed the 2 cases were not sent out for further review by another Dermatopathologist and that the list to choose from was blank. 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 and interview with the Mohs' Technician (MT), the laboratory failed to ensure tissue marking dyes used in histopathology testing did not exceed their expiration dates for 3 (Tissue Marking Dyes - red, violet, and orange) of 7 tissue marking dyes observed. Findings include: 1. The surveyor observed 7 tissue marking dyes in the laboratory in use on 8/28/2023 at 10:25 am and the following had exceeded their expiration date: a. Tissue Marking Dye red lot #122213 expiration date 5/31/2023. b. Tissue Marking Dye violet lot #122226 expiration date 5/31/2023. c. Tissue Marking Dye orange lot #095946 expiration date 3/31/2022. 2. An interview on 8/28/2023 at 10:25 am, the MT confirmed the tissue marking dyes listed above had exceeded their expiration dates. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall -- 2 of 3 -- quality of the postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . The laboratory failed to meet applicable postanalytic system requirements. Findings include: 1. The laboratory failed to establish a system to ensure the transcribed Mohs' surgery site was accurately transcribed from the Pathology report onto the Mohs' log, Moh's map, and the visit note. Refer to D5801. 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 record review and interview with the Mohs' Technician (MT), the laboratory failed to establish a system to ensure the transcribed Mohs' surgery site was accurately transcribed from the Pathology report onto the Mohs' log, Moh's map, and the visit note for 5 (M22-215, M22-394, M22-613, M22-724, M22-927) of 8 Mohs' cases reviewed. Findings include: 1. A record review revealed for 5 of 8 Mohs' cases reviewed, the anatomical site transcribed from the Pathology Report onto the Mohs' log, Mohs' map, and/or visit note was not transcribed accurately as follows: a. M22- 215 performed on 4/04/2022. i. Pathology report - left inferior posterior helix. ii. Mohs' log, Mohs' map, and visit note - left superior helix. b. M22-394 performed on 6 /16/2022. i. Pathology report - right cheek ii. Mohs' log, Mohs' map, and visit note - right superior preauricular cheek. c. M22-613 performed on 8/30/2022. i. Pathology report, Mohs' log, and Mohs' map- right cheek ii. Visit note - right superior lateral buccal cheek. d. M22-724 preformed on 10/06/2022. i. Pathology report - presternalis region upper ii. Mohs' log - presternalis upper iii. Mohs' map - location changed to left medial superior chest. iv. Visit note - only noted left medial superior chest. e. M22- 927 performed on 12/12/2022. i. Pathology report, Mohs' log, and Mohs' map - scalp ii. Visit note - right superior parietal scalp 2. A review of the "Mohs Surgery Documentation Policy & Procedure" signed by the Laboratory Director on 4/12/2022 states: " 1. Mohs surgery site locations(s) shall match in all of the following: a. Pre-op Biopsy Report b. Mohs Map c. Mohs Log d. Final Report in EMR 2. Once Dr. Leithauser examines the patient, and if she determines that the pre-op biopsy location is not accurate, she will write the original location (from the pre-op biopsy report) on the Mohs Map and cross it off with a single line. The correct location will be added next to the incorrect, crossed off location. 3. All other reporting, including the Mohs' Log and the Final EMR Report, will match in location. 4. All staff is to ensure all locations are correct and this will also be confirmed by the Clinical Manager and Dr. Leithauser upon report finalization." 2. An interview on 8/28/2023 at 12:51 pm, the MT confirmed the above incorrectly transcribed anatomical sites just prior to and post the new procedure being signed by the Laboratory Director. -- 3 of 3 --

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 Liaison (LL) and the Office Manager (OM), the laboratory failed to verify the accuracy of its microscopic tissue examination testing at least twice annually for 2 (March 2020 to March 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's verification of accuracy documentation revealed the following: a. 2020 - no cases sent out twice annually b. 2022 - no cases sent out for 1 of 2 twice annually 2. An interview on 3/21 /2022 at 10:05 am, the LL and OM confirmed the twice annual verification of accuracy testing for its microscopic tissue examinations was not performed and documented. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Liaison (LL) and Office Manager (OM), the laboratory failed to follow quality assurance policies for 2 (March 2020 to March 2022) of 2 years reviewed. Findings include: 1. A review of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory's established "Quality Assurance" program, the laboratory failed to complete the "Monthly Patient Quality Assurance Checklist" for 2 (March 2020 to March 2022) of 2 years reviewed. 2. A record review revealed a "CLIA Lab Modification/Correction" dated March 1, 2022 stated "Begin to implement monthly patient quality assurance review." 3. An interview on 3/21/2022 at 10:07 am, the LL and OM confirmed the laboratory had not followed the monthly quality assurance program. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Liaison (LL) and Office Manager (OM), the laboratory failed to have test requests for frozen section biopsies from an authorized person for 2 (M20-573 and FB21-005) of 10 patient test requests reviewed. Findings include: 1. A review of patient test requests revealed a lack of an order in the patients electronic medical record (EMR) from an authorized person for the following frozen section biopsies: a. M20-573 performed on 11/05/2020 b. FB21- 0005 performed on 12/21/2022 2. An interview on 3/21/2022 at 10:55 am, the LL and OM confirmed there was no test request in the EMR for the 2 patients listed above. 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: . Based on record review and interview with the Laboratory Liaison (LL) and the Office Manager (OM), the laboratory failed to ensure the Hematoxylin and Eosin (H&E) stain case number was recorded, performed, and documented each day of patient testing for 2 (March 2020 to March 2022) of 2 years reviewed. Findings include: 1. A review of the "Quality Assurance" section on the bottom of the "Laboratory Control Staining" log states, "The first case submitted to the mohs lab which consists of normal tissue will be stained for H&E, documented on the control sheet as the QA. This slide will be kept in the file with the case." 2. A review of the laboratory's "Laboratory Control Staining" log for the H&E stain quality revealed for 2 of 2 years reviewed the following days the case number which the quality of the stain was performed on was not recorded on the log as follows: a. 11/4/2021 b. 12/7-9 /2021 c. 12/13-14/2021 3. A chart audit revealed for 2 of 2 years the H&E stain was not recorded on the "Quality Control Staining" log for the following Mohs' and frozen section cases: Mohs" a. 1/18/2021 - M21-032 b. 5/25/2021 - M21-265 c. 7/12/2021 - M21-365 d. 9/01/2021 - M21-512 Frozen Sections a. 2/22/2021 - M21-117 b. 8/18 -- 2 of 4 -- /2021 - M21-457 c. 10/28/2021 - M21-669 4. An interview on 3/21/2021 at 9:46 am, the LL and OM confirmed there was no documentation on the stain log of the stain case number, stain quality performed, and documented each day of patient testing D5785

Summary Statement of Deficiencies 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 record review and interview with the Laboratory Director (LD), the laboratory failed to enter the corresponding specimen source location from the Pathology report onto the patient's Mohs' map and electronic medical record (EMR) file for 5 (#2, #5-#8) of 11 patient charts audited. Findings include: 1. Record review for 5 of 11 patient chart's audited revealed the specimen source location was not transcribed consistently from the Pathology report to the Mohs' map and the final EMR report as follows: a. #2 1. Pathology report - scalp and neck 2. Mohs' map - posterior neck 3. EMR report - left inferior posterior neck b. #5 1. Pathology report - left inferior central malar cheek 2. Mohs' map - left inferior central malar check 3. EMR report - left central malar cheek c. #6 1. Pathology report - mid chin 2. Mohs' map - mid chin 3. EMR report - left chin d. #7 1. Pathology report - right anterior lower leg 2. Mohs' map - right distal pretibial region 3. EMR report - right distal pretibial region e. #8 1. Pathology report - right temporal scalp 2. Mohs' map - right temporal scalp 3. EMR report - right lateral forehead 2. During the interview on 11/14 /19 at 3:00 pm, the LD acknowledged the specimen source location did not correlate between the three reports - Pathology report, Mohs' map, and EMR report. 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 --