Dermatology And Skin Cancer Consultants, Pllc

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, lack of documentation, procedure manual review, review of patient accessioning logs, and staff interviews, the laboratory failed to perform competency assessments for scabies examinations for three of three testing personnel in 2024 and 2025. The findings include: 1. Laboratory observation on 07/22 /25 at 8:15 a.m. revealed a microscope used for reading histopathology slides and examining skin scrapings for fungal elements and scabies. 2. Scabies competency assessment for testing persons two, three, and four was not documented in 2024 and 2025. 3. A review of the laboratory procedure manual revealed the following statement under section 10. 3. "Twice a year, the Laboratory Director will observe all testing personnel performing a KOH prep for accuracy in technique and specimen collection." Under section XIV-"SCABIES SKIN SCRAPING PROCEDURE," the following was noted: "Competency protocol for scabies preps is the same as for KOH preps above." 4. A review of patient accessioning logs revealed that four scabies exams were performed since the last survey date of 04/02/2024, for patient number 12500 on 01/07/25, patient number 38741 on 01/14/25, and patient number 2026 on 07 /01/25 on two separate sites. Testing person three performed all four scabies examinations. 5. The laboratory director confirmed the survey findings during an interview on 07/22/25 at 12:00 p.m. Work Key: KOH=Potassium Hydroxide D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) 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 -- (c)(2) 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 laboratory observation, a review of the laboratory procedure manual, a review of patient test reports, lack of documentation, and staff interview, the laboratory failed to verify the accuracy of scabies examination twice a year in 2025, with three patients tested. The findings include: 1. Laboratory observation on 07/22 /25 at 8:15 a.m. revealed a microscope used for reading histopathology slides and examining skin scrapings for fungal elements and scabies. 2. A review of the laboratory procedure manual revealed that accuracy for scabies is determined by the laboratory director reviewing a captured photo maintained in the patient chart to determine agreement with the original interpretation. 3. A review of patient test reports revealed that four scabies exams were performed in 2025 for patient number 12500 on 01/07/25, patient number 38741 on 01/14/25, and patient number 2026 on 07 /01/25 (two separate sites). None of the four had captured images maintained as part of the patient chart. 4. The laboratory director had not documented a second review of the examinations, resulting in the laboratory failing to verify the accuracy of the scabies exam twice a year in 2025. 5. The laboratory director confirmed the survey findings during an interview on 07/22/25 at 12:00 p.m. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on laboratory observation, review of testing personnel competency assessments, and staff interviews, the technical consultant failed to include blind testing as part of the Potassium Hydroxide (KOH) fungal detection competency assessment documentation in 2024 and 2025 for six of six competency assessments reviewed for three of three testing personnel. The findings include: 1. Laboratory observation on 07/22/25 at 8:15 a.m. revealed a microscope used for reading histopathology slides and examining skin scrapings for fungal elements and scabies. 2. A review of testing personnel KOH competency assessments revealed that six of six KOH competency assessments performed for testing persons two, three, and four in 2024 and 2025 did not include documentation of blind testing assessment. 3. The laboratory director confirmed the survey findings during an interview on 07/22/25 at 12:00 p.m. -- 2 of 2 --

Summary Statement of Deficiencies 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 patient accessioning records, and interview with the lead histotech, the laboratory failed to maintain accessioning records that were separate from a sister laboratory in 2020, 2021 and 2022 resulting in the potential for the same accessioning number being issued to multiple cases. The findings include: 1. Observation of the laboratory on 11/8/22 at 7:30 am revealed the laboratory performs testing for histopathology on patient tissue removed during MOHS procedures. 2. During the patient test management review it was noted that the accessioning records for this laboratory were not maintained separately from a sister lab. 3. Interview with the lead histotech on 11/08/22 at 9:15 am confirmed the laboratory did not maintain separate accessioning records for MOHS/histopathology cases that were distinct from a sister laboratory in 2020, 2021, and 2022. 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 review of laboratory records and interview with the lab director, 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 2 -- laboratory failed to ensure the verification of accuracy for its' histopathology patient testing was performed twice a year in 2020, 2021, and 2022. The findings include: 1. Review of laboratory verification of accuracy records for histopathology revealed that verification of accuracy was not performed twice in 2020, 2021, and 2022. 2. Interview with the lab director on 11/08/22 at 10:30 am confirmed the laboratory failed to verify the accuracy of its' histopathology procedures twice a year in 2020, 2021, and 2022. 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 observation of the laboratory, lack of documentation, and interviews with the lead histotech and the laboratory director, the laboratory failed to maintain records of chemicals, stains, and dyes used for processing tissue removed during MOHS surgical procedure and quality assessment when new reagents were opened in 2020, 2021 and 2022. The findings include: 1. Observation of the laboratory on 11/08/22 at 7:30 am revealed multiple chemicals, stains (Hematoxylin and Eosin), and dyes in use for performing processing, staining, and inking of patient tissue removed during MOHS surgical procedures. 2. There was a lack of historic records for chemicals, stains and dyes to include reagent lot numbers, date opened, expiration date, and stain quality control/quality assessment when the reagents and stains were opened. 3. During an interview with the lead histotech on 11/08/22 at 9:15 am the lead histotech stated that he checked and recorded the lot numbers and expiration dates monthly, but the record is then discarded. 4. Interview with the lab director at 10:30 am confirmed the laboratory failed to maintain historic reagent and quality assessment records that included lot numbers, date opened, expiration date and stain quality assessment when new reagents/stains were opened in 2020, 2021, and 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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 2017, 2018 and 2019 laboratory temperature records and interview with the laboratory director, the laboratory failed to document the temperature of the cryostat, in 2017, 2018 and 2019. The findings include: 1) Observation on July 11, 2019 at 10:00 a.m. of the laboratory revealed two cryostat instruments in use for patient sample preparation. 2) Review of the 2017, 2018 and 2019 laboratory temperature records revealed one temperature recording for a cryostat. 3) Interview on July 11, 2019 at 11:15 a.m. with the laboratory director confirmed the second cryostat instrument temperature documentation was not performed in 2017, 2018 and 2019. 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. 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 observation of the laboratory and interview with the supervisor of the laboratory, the laboratory failed to ensure expired potassium hydroxide (KOH) was not in use past the expiration date, in 2019. The findings include: 1) Observation on July 11, 2019 at 10:10 a.m. of the laboratory revealed a bottle of KOH lot number 1816506 expiration date June 14, 2019. 2) Interview on July 11, 2019 at 11:45 a.m. with the laboratory director confirmed the KOH expired on June 14, 2019 with patient testing in use from June 15, 2019 to current survey date. -- 2 of 2 --