Naaman Clinic

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 the Post Analytical reviews of the Surgical Map, the Visit Note and an interview with the Mohs Technician, the laboratory failed to ensure the Accession Number assigned to the patient was preserved for the entire visit. The surveyor noted one of the five patients selected and reviewed from October 2024 to July 2026, did not have the same Accession Number listed on the Surgical Map and the Visit Note reports in 2024. Findings include: 1. A review of the Surgical Map and the Visit Note for MRN 22886 revealed there were two different Accession Numbers for these reports. 2. A further review of MRN 22886, patient date of service, December 16, 2024, had the following Accession Numbers. A) Surgical Map Report, M24-643 B) Visit Note Report, M23-643 3. The MOHS Technician confirmed the above findings during the exit conference on 07-14-2026 at 1PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the Cryostat maintenance logs, patient history records and an 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 -- interview with the MOHS Technician, the laboratory failed to document Cryostat monthly maintenance as indicated on the maintenance log form. The surveyor noted 3 out of the 21 months reviewed from October 2024 to June 2026 had no documentation of the monthly maintenance for the two cryostat utilized in the laboratory. The findings include: 1. A review of the Leica CM 1850 and Micron HN 520 Cryostat maintenance logs revealed no documentation of the required monthly maintenance for three months in 2024. 2. A further review of the maintenance logs for both cryostats revealed places to document the following required monthly maintenances. A) Thermometer Check B) Moving Components C) Clean Air Filter D) Defrost Machine 3. A review of the patient history records revealed 164 patients were performed when the monthly maintenance was not documented. 4. The MOHS Technician confirmed the above findings during the exit conference on 07-14-2026 at 1PM. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the Post Analytical reviews of the Surgical Map, the Visit Note and an interview with the Mohs Technician, the laboratory failed to ensure the Quality Assessment Program was able to monitor and detect inaccuracies on test report information. The surveyor noted two of the five patients selected from October 2024 to July 2026 did not have the same diagnosis on the Surgical Map and Visit Note. Findings include: 1. A review of the Surgical Maps and the Visit Notes for Medical Record Numbers (MRN) 22886 and MM0000006616 revealed two different diagnoses between the Surgical Map and the Visit Notes. 2. A further review of MRN 22886 and MM0000006616 revealed the following dates and diagnoses. A) MRN 22886, Surgical Map Date of Service, 12/16/2024 had a diagnosis of Squamous Cell Carcinoma in Situ (SCCIS), Visit Note December 16, 2024, had a diagnosis of Squamous Cell Carcinoma (SCC) for PreOp and PostOp Diagnoses. B) MRN MM0000006616, Surgical Map Date of Service, 7/6/2026 had a diagnosis of Squamous Cell Carcinoma in Situ (SCCIS), Visit Note July 6, 2026, had a diagnosis of Squamous Cell Carcinoma (SCC) for PreOp and PostOp Diagnoses. 3. The MOHS Technician confirmed the above findings during the exit conference on 07-14-2026 at 1PM. -- 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 a review of the Linistat Linear Stainer, Microm HM520 and Leica CM1510s (cryostats) Operator's Manuals, a review of the Cryostat Maintenance Records, a review of the patient test logs, and an interview with the laboratory technician, the surveyor determined the laboratory failed to monitor and document room temperature and humidity each day of patient testing. This affected the survey review period from March 2018 to October 2020. The laboratory further failed to monitor and document the cryostat's temperature for December 2018. The findings include: 1. A review of Linistat Linear Stainer Operator's Manual Chapter 1 Table 1-8 stated "General environmental specification - Temperature (Operating Limits) +5 degrees Celsius to +40 degrees Celsius - Relative Humidity Max. 80% RH up to 31 degrees Celsius Decreasing linearly to 50% RH at 40 degrees Celsius." A review of Microm HM520 Operator's Manual stated "Operating conditions +5 degrees Celsius up to +35 degrees Celsius (at a max. relative humidity of 60%)." A review of Leica CM1510s Operator's Manual stated "Operating temperature range from +18 degrees Celsius to +35 degrees Celsius. All specifications related to temperature are based on an ambient temperature of +22 degrees Celsius and maximum air humidity of 60%." 2. A review of the Cryostat Maintenance records revealed the following missing documentation: a) The laboratory did not document the cryostat temperature [established -15 - (-)30 degree 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 -- Celsius] for the month of December, 2018. The patient test log revealed 76 patients were tested in December, 2018. 3. During an interview on 11/18/2020 at 11:30 AM, the laboratory technician reviewed the maintenance record for the cryostats and confirmed no documented temperatures for December of 2018. At 11:50 AM, the laboratory technician confirmed the laboratory had not monitored room temperature and humidity from March 2018 to October 2020. -- 2 of 2 --