Advocare Olivo Dermatology Center

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 the Leica DM 750 Microscope and Leica CM1510S Cryostat Instruction Manuals (IM) and interview with the Laboratory Director (LD) and Testing Personnel #2 (TP #2) provided on the CMS-209, the laboratory failed to provide the correct room temperature and humidity per the IM's requirements in the laboratory from 4/8/21 to the date of the survey. The findings include: 1. The surveyor observed that the strictest requirements for room temperature was 18-40C and humidity was 20-60% based on the IM's specifications. 2. The LD and TP #2 confirmed on 8/15/23 at 1:00 pm that the acceptable laboratory room temperature and humidity provided on the daily log was not strict enough. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log and interview with the Laboratory Director (LD), the laboratory failed to retain patient test record for Mohs tests from 8 /28/17 to the date of the survey. The finding includes: 1. One out of ten Patient work records Mohs Map (MM) was not available for review. 2. The LD confirmed at 10:45 am 8/16/18 MM was not retained. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, interview with the Laboratory Director (LD), and in house review of the previous Pan Of Corrections (POC) the laboratory failed to establish written procedures for Biannual Assessment (BA) from 8 /21/14 to the date of survey. The findings include; 1) There was no evidence that a BA 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 -- procedure was written. 2) The