Summary:
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: Through a review of the Temperature Charts for 2020 and 2021 it was determined the laboratory temperatures were not documented legibly. Survey findings include: A. During a review of the laboratory Temperature Charts for 2020 and 2021 room temperatures could not be determined to be acceptable due to the handwriting of the laboratory personnel being illegible. B. At 2:40 p.m. on 4/13/2021, laboratory employee #3 (as listed on the form CMS-209) confirmed the room temperature documentation was illegible. 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 --