Z-Roc Dermatology Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Z-ROC DERMATOLOGY LLC from September 17, 2025 to September 29, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 staff interview, the laboratory failed to verify the accuracy of Histopathology testing at least twice annually for 1 (2024) out of 2 years (2024-2025) reviewed. Findings included: 1. Personnel records reviewed revealed that in the Histopathology section there were two testing personnel TP1 (laboratory director), and TP2 (histology technician) as per CMS 209 Form. 2. Review of Subpart I, 42 CFR Part 493.901 through 493.959 revealed that there was no approved proficiency testing programs for the interpretation of stained tissues. 3. Review of the laboratory procedure stated in Proficiency Testing (PT) "Semi-annually a case will be randomly selected by the histotechnologist and will be submitted to a Board-Certified Dermatopathologist/Dermatologist or Mohs Surgeon for review." 4. Review of the Quality Assurance (QA) peer review found that peer review for Histopathology was done for TP1 on 04/30/2024. The Laboratory did not provide another record for PT in 2024 because the laboratory had closed from 08/26/2024 to 07/21/2025. 5. Review of the Mohs log record revealed that the laboratory tested approximately 223 patients dated from January 8, 2024 to August 26, 2024. 6. During an interview on 09/17/2025 at 11:48 AM, the Risk Management consultant confirmed there was one QA peer review documented for the year 2024 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 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 record review and interview with the histology technician, the laboratory failed to document the room temperature and humidity in the room where the cryostat is during 2016, 2017 and 2018. The laboratory failed to document the cryostat temperatures for 4 out 16 days in May 2017. Findings include: 1-Review of the cryostat installation requirements revealed that there is a requirement for room temperature range 18-35 C and for humidity no more than 60 %. Review of temperature logs revealed that there was no documentation of room temperature nor humidity in 2016, 2017, and 2018. 2- Review of cryostat maintenance sheet revealed that there is a requirement to record the cryostat temperature every day of use. They used cryostat 16 days in May 2017 (1,2,4,5,8,9,11,12,15,16,17,18,22,25,26 and 30), there was no documentation of cryostat temperatures record in May (22, 25, 26 and 30) 3-During an interview on 04/18/18 at 11:00 a.m., the histology technician confirmed that there was no documentation of room temperature nor humidity during 2016, 2017, and 2018 for the cryostat room also confirmed that there was no documentation of cryostat temperature for the days cited above. 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 --