Dermatology Center Of New Jersey,Pc, The

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 the review of the Biannual Assessments (BA) records and interview with the Office Manager (OM) the laboratory failed to verify the accuracy of Histopathology testing biannually in the calendar year 2025. The finding includes: 1. There was no documented evidence the laboratory verified the accuracy of histopathology testing in the calendar year 2025. 2. The OM confirmed on 7-22-26 11am, the laboratory did not verify the accuracy of Histopathology testing in the calendar year 2025. D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on the lack of an Accession Log (AL) and interview with Office Manager (OM), the laboratory failed to maintain an information or record system for Mohs tests performed from from 1/1/26 to 7/22/26. The findings include: 1. The laboratory did not have an AL for 2026 2. The OM confirmed on 7/22/26 at 11:00 pm, 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 did not have an information or record sytem that ensured positive patient idenification through all phases of Mohs testing performed. -- 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 surveyor review of temperature logs, observation of the lack of a thermometer, and interview with the Laboratory Director (LD) the laboratory failed to monitor and document room temperature on each day of Mohs testing from 1/23/18 to the date of survey. The LD confirmed on 2/25/20 at 1:20 pm that the laboratory did not document room temperature. 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 D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory procedures and interview with the Office Manager (OM), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the applicable elements for Mohs Technicains from 11/10/15 to the date of the survey. The GS confirmed on 1/23/18 at 2:10 pm that a CA procedure was not established. 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 --