Coastal Skin Surgery And Dermatology

Summary Statement of Deficiencies D0000 An on - site announced CLIA recertification survey was conducted at Coastal Skin Surgery on 03/05/24. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on interview with the Mohs Technician, observation of the Laboratory Director's office closet, and review of the Avantik UltraClear Xylene Substitute (Xylene Substitute) Safety Data Sheet (SDS) , the laboratory failed to follow manufacturer's instructions for Xylene Substitute disposal and storage. Findings Included: -Interview with the Mohs Technician on 03/05/24 at 9:03 a.m., revealed the Xylene Substitute was discarded down the drain after use. - Observation of the Laboratory Director's closet on 03/05/24 at 9:10 a.m., revealed seven bottles of Xylene Substitute that were not contained in a fireproof cabinet. -Review of the Avantik Xylene Substitute SDS revealed that Xylene Substitute must be stored in a fireproof location and kept out of sewers and waterways, because it is a hazard to the aquatic environment. 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 operating conditions and temperatures of the Cryostat Histopath QS 11 equipment each day of patient testing in accordance with CLIA requirements for the whole time that the laboratory was set up. Findings included: Review of the equipment's manufacturer procedure indicated that the AVANTIK QS 11 Cryostat requires an operating condition of 5 degrees centigrade to 35 degrees centigrade at a maximun relative humidity of 60 %. There was no room temperature and humidity log available for documenting the temperature of the laboratory room from May 2016 to 2018. Interview on 5/9/18 at 11:30 AM, testing person # 2 confirmed that the temperature and humidity of the laboratory room were not checked and documented daily since the time the laboratory had operated. 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 --