Dermatology Associates Of Denison Pllc

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 direct observation, review of manufacturer's instruction manual, and confirmed in staff interview, the laboratory failed to follow manufacturer's instructions for ensuring 1 of 1 microscope was covered with a dust cover when not in use. Findings included: 1. During a tour of the laboratory on 12/16/2024 at 12:30 p. m., the surveyor observed the Olympus BX41 microscope (Serial #7D1533) uncovered. The microscope was not in use on the day of inspection. 2. Review of Olympus BX41 microscope instruction manual revealed: "Maintenance and Storage ... 5. When the microscope is not in use, be sure to set the main switch to "O" (OFF). After checking that the lamp socket had been cooled down, place the dust-prevention cover on the microscope for storage." 3. During an interview on 12/16/2024 at 12:46 p. m., the Medical Assistant Supervisor and Receptionist confirmed the laboratory failed to follow manufacturer's instructions for ensuring the microscope was covered with a dust cover when not in use. 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 D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with laboratory representatives at the entrance and exit conferences. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties /subspecialties surveyed for 45 CFR 493.1230 General Laboratory Systems; 493.1250 Analytic Systems 493.1441 Laboratory Director, (high complexity) 493.1487 Testing Personnel (high complexity) Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the