Levy 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 laboratory observation, a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS 209), patient test reports, the Mohs accessioning log, the laboratory procedure manual, and staff interview, the laboratory failed to have a policy for assessing competency for positions delegated by the laboratory director to the sole testing person who performed grossing (inking and mapping) of tissue removed during Mohs procedures, and reading of the histopathology slides. The findings include: 1. Laboratory observation on 11/10/25 at 12:30 p.m. revealed equipment used for processing tissue removed during Mohs procedures and a microscope used for reading the tissue slides. 2. A review of the Form CMS 209 revealed a testing person other than the laboratory director. 3. A review of patient test reports revealed that the first case performed by the sole testing person was for MOHS case number M24-01 on 04/08/24. 4. A review of the Mohs accessioning log revealed that 81 patients were tested in 2024 and a total of 120 in 2025. 5. A review of the laboratory's procedure manual revealed no policy or procedure for assessing testing personnel competency. 6. The lead histotech confirmed the survey findings during an interview on 11/10/25 at 2:15 p.m. 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 observation of the laboratory, review of laboratory records and patient test records, and interview with the office manager/histotech the laboratory failed to verify the accuracy of its' histopathology procedures twice a year 2022. The findings include: 1. Observation of the laboratory on 01/10/23 at 8:30 am revealed equipment in use for performing processing and staining of tissue removed during Mohs surgery, as well a microscope used by the dermatologist for interpretation of histopathology slides. 2. Review of laboratory records revealed verification of accuracy was not performed twice per year in 2022. 3. Review of patient records revealed testing for histopathology performed on patient case #M22-016 performed on 01/25/22 and patient case #M22-151 performed on 09/02/22. Patient accessioning logs revealed that approximately 181 patients had histopathology procedures performed in 2022. 4. Interview with the office manager/histotech on 01/10/23 at 11:45 am confirmed the laboratory did not perform twice a year verification of histopathology procedures in 2022 with patient testing performed. 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. 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 procedure manual, the laboratory reagent log, and interview with the office manager/histotech, the laboratory failed to follow the procedure for recording stain reactivity when opening new reagents in 2021, 2022, and 2023. The findings include: 1. Review of the laboratory procedure titled "Histopathology - Mohs Surgery" revealed the following under section 4.2.3: Stains, reagent and dyes are logged and the stain reaction is recorded. 2. Review of the laboratory reagent log revealed no documentation of stain reaction/acceptability when reagents were opened from 08/16/21 until the date of the survey on 01/05/23. 3. Interview with the office manager/histotech on 01/10/23 at 11:45 am confirmed the laboratory failed to follow its' own procedure for recording stain reactivity when new reagents/stains were opened in 2021, 2022 and 2023. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 observation of the laboratory, review of the manufacturer's operating manuals, environmental records, annual test volumes and interview with the office manager/histotech, the laboratory failed to monitor room humidity for the Avantik QS12 cryostat and the Linistat automated stainer in 2020, 2021, and 2022. The findings include: 1. Observation of the laboratory on 01/10/23 at 8:30 am revealed the Advantik QS12 cryostat (serial #S16099837) and the Thermo Scientific Linistat automated stainer (serial #LS5167A1704) in use for processing tissues removed during Mohs surgical procedure in preparation for histopathology procedures. 2. Review of the manufacturer's operating manuals revealed the following: Avantik QS 12 cryostat environmental conditions require a maximum relative humidity of 60%. Linistat automated stainer environmental conditions require a maximum relative humidity of 80% 3. Review of the laboratory's environmental records for the months of 07/2020, 02/2021, 09/2021, 01/2022, 09/2022, and 01/2023 revealed no monitoring of room humidity. 4. Review of the laboratory annual test volume estimates revealed approximately 500 patients tissues were processed during the period the humidity was not being monitored. 5. Interview with the office manager/histotech on 01/10/23 at 11: 45 am confirmed the laboratory did not monitor room humidity for the use of the cryostat and Linistat automated stainer in 2020, 2021, 2022 and 2023. -- 2 of 2 --

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to ensure positive patient identification for labeling Mohs histological slides (Refer to D5203); failed to verify the accuracy of the biopsy analyte twice per year (Refer to D5219); failed to establish a written policy/procedure for the patient test management assessment (Refer to D5291); failed to ensure the hematoxylin and eosin stain solution were not in use after expiration date (Refer to D5417) and, failed to include the lot numbers, date prepared/opened, expiration dates, the actual reactions and/or observations and demonstrated that controls were tested when shipments of stains were opened (Refer to D5609). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual and interview with testing personnel number two, the laboratory failed to follow the procedure to ensure positive patient identification for labeling Mohs histological 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 -- slides. The findings include: 1) Observation on August 6, 2019, at 11:55 a.m. of the laboratory revealed on July 29, 2019, patient number three had three slides prepared for Mohs testing, with one slide labeled, "QA 7-29-19" 2) Review of the procedure manual revealed, "3.4.9 Laboratory technician will cut frozen sections and stain. Slides are labeled with Mohs number, patient last name and 1st initial, stage (S1L1), piece # (numbers) and slide# (letters)." 3) Interview on August 6, 2019 at 11:56 a.m. with testing personnel number two confirmed that during 2018 and 2019 each morning the first patient slide prepared is used for daily quality control and is labeled as QA. The slide labeled as QA is also in use for patient reporting but does not have the positive patient identification labeled on the slide. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the procedure manual, the quality control records and interview with testing personnel number two, the laboratory failed to verify the accuracy of the biopsy twice per year in 2018 and 2019. The findings include: 1) Based on review of the procedure manual revealed the following: "Quality Control X 6.1.4 The laboratory participates in the Quality Assurance reading of slides sent to _(redacted pathologist name), MD at (redacted name of facility). A minimum of 2 random slides between cases are sent every 6 months." 2) Review of the quality control records revealed no biopsy slides were included in the quality assurance reviews in 2018 and 2019. 3) Interview on August 6, 2019 at 10:45 a.m. with testing personnel number two confirmed that no biopsy slides were sent for verification of accuracy in 2018 and 2019. 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 observation of the laboratory, review of the laboratory procedures, the "Quarterly Patient QA" records, and interview with testing personnel number two, the laboratory failed to establish a written policy/procedure for the patient test management assessment, in 2018 and 2019. The findings include: 1) Observation on August 6, 2019, at 11:53 a.m. of the laboratory revealed two slides on patient number two for Mohs testing. 2) Review of the laboratory procedures revealed no written procedure for the quarterly patient quality assessment process. 3) Review of the Quarterly Patient QA records revealed on 7-29-19, patient number two records and slides were reviewed for quality assessment. 4) Interview on August 6, 2019, at 12:05 p.m. with testing personnel number two confirmed there is no written procedure for the quarterly patient quality assessment process. Patient number two records indicated -- 2 of 3 -- that there are three slides but only two slides were located. There is no written procedure for how to monitor, assess, and correct problems for the patient test management pre-analytic, analytic and post-analytic processes. 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 the laboratory and interview with testing personnel number two, the laboratory failed to ensure the hematoxylin and eosin stains were not in use after the expiration dates. The findings include: 1) Observation on August 6, 2019 at 11:06 a.m. of the laboratory revealed the Gill 3 Hematoxylin lot number 062851 expiration date 06/19 and Avantik Eosin Working Solution lot number G128-02 expiration date 5/8/19 in use for patient testing. 2) Interview on August 6, 2019 at 11: 06 a.m. with testing personnel number two confirmed the hematoxylin and eosin stains were expired and in use for patient testing. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the Mohs Lab Controls-Maintenance for Linistat Stainer records, the Quality Assurance (QA) Slides records and interview with testing personnel number two, the laboratory failed to include the lot numbers, date prepared/opened, expiration dates, the actual reactions and/or observations, and demonstrated that controls were tested when shipments of stains were opened, in 2018 and 2019. The findings include: 1) Review of the Mohs Lab Controls-Maintenance for Linistat Stainer records and the Quality Assurance (QA) Slides records revealed following were not documented for the hematoxylin and eosin stains: lot number, expiration dates, opened dates, actual reactions of the stain, and when the new lot of stains were opened and tested. 2) Interview on August 6, 2019 at 11:30 a.m. with testing personnel number two confirmed the lot number, expiration dates, opened dates, actual reactions of the stains and the new lot of stain when opened and tested were not documented in 2018 and 2019. Patient testing was performed and reported in 2018 and 2019. -- 3 of 3 --