Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Laboratory of Florida on 09 /19/22 - 09/26/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 with the Technical Supervisor, the laboratory failed to record the freezer temperature for freezer #9 every day that ammonia testing was performed for 12 days out of 497 days. Findings Included: Review of the laboratory's policy and procedure titled "Temperature and Humidity Monitoring" revealed the policy was "To monitor the relative temperature and humidity in each testing area of the laboratory on a daily basis where analyzers, refrigerators and freezers are temperature dependent. To Maintain the integrity of reagents, controls, media and samples." The procedure revealed "Technologist or Technicians will be responsible to document the temperatures and humidity in each testing area of the lab." and "Freezer temperatures must be maintained at less than - 20 degrees Celsius." Review of the manufacturer's instructions (MI) for "Beckman Coulter Infinity (Trademark) Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers" revealed "Ammonia samples are stable for 3 hours at 2 - 4 degrees Celsius or 24 hours Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- at - 20 degrees Celsius. Review of the MI for "Liquichek Elevated CRP Control" revealed the Level 1 and Level 3 controls should be stored between -20 degrees Celsius degrees and - 70 degrees Celsius. Review of the "Temperature Fridge/Freezer log" for freezer #9 revealed the following days of ammonia testing did not have freezer temperatures documented: 12/28/21 - 14 patients tested, 12/29/21 - 4 patients tested, 12/30/21 - 6 patients tested, 01/28/22 - 7 patients tested, 09/08/22 - 17 patients tested, 09/09/22 - 14 patients tested, 09/12/22 - 8 patients tested, 09/13/22 - 8 patients tested, 09/14/22 - 12 patients tested, 09/15/22 - 26 patients tested, 09/16/22 - 15 patients tested, and 09/19/22 - 12 patients tested. During an interview on 09/26/22 at 2: 50 PM, the Technical Supervisor stated the technologist forgot to document freezer #9 temperatures on the aforementioned days. D5781