Emerald Coast Dermatology And Skin Surgery

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Emerald Coast Dermatology And Skin Surgery PA on April 2, 2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review of the slides and test reports in the specialty of Histopathology and interview with the Laboratory Director, the laboratory failed to ensure accurate labelling of a patient specimen on 1 of 5 slides for 2 of 2 years (2018- 2020) reviewed. Findings included: Review of the test report and slide of patient # 3 tested on 6/14/19 revealed discrepancies of the patient's name of the slides and test report. Review of the slides and test report showed same accession number but with different names. Interview with the Laboratory Director on 04/02/20 at 1:00 PM confirmed that the laboratory failed to change the name on the label of the slide that will accurately match the patient's name. 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, it was determined that the laboratory did not document room temperature and humidity requirements to assure optimal storage temperatures for certain reagents for 2 years ( 2016-2018). Findings included: Review of the manufacturer's procedure indicated that the Multienzyme Cleanser and Paragard Paraffin Repellent should be stored at 22 degrees Centigrade and 35 degrees Centigrade. There was no temperature log available for documenting the temperature of the laboratory room. Interview on 3/7/18 at 11:30 AM, testing person # B confirmed that the temperature and humidity of the laboratory room were not checked and documented. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result 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 -- reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to perform yearly preventive maintenance on the Olympus CX31 microscope for 2 years ( 2016 - 2018 ). Findings included: Observation on 3/7/18 at 10:30 AM showed that the Olympus CX31 microscope did not have a preventive maintenance sticker. Review of the equipment maintenance records for 2016 - 2018 showed no documentation for annual preventive maintenance done on the microscope. Interview on 3/7/18 at 12:00 PM , personnel # A confirmed that the laboratory did not have records to show annual preventive maintenance on the microscope. -- 2 of 2 --