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: Based on surveyor observation, record review and staff interview, the laboratory failed to follow manufacturer instructions for proper reagent storage in the specialty of chemistry. 1. Surveyor observation on 7/22/19 at 12:20 PM of the laboratory freezers revealed the following reagent kits and quality control reagents with the following manufacturer storage requirements: a. Old Freezer (Hall) i. Liquicheck Special ImmunoAssay Control - Level 1, Lot number 60261, Level 2, Lot number 60262, store at -20 to -70 degrees Celsius. ii. MAS Chemtrak H Liquid Assayed Chemistry Control - Level 1, Lot number CHA20111A, Level 2, Lot number CHA20112A, Level 3, Lot number CHA20113A, store at -15 to -25 degrees Celsius. b. New Freezer (Hall) i. HDL Cholesterol Verifier Kit, Verichem Labs Inc., Lot number K382707, store at -15 to -25 degrees Celsius. ii. Access Free T4 Cal, Lot number 832347, store at -20 degrees Celsius or colder. iii. Access Folate Cal, Lot number 832321 and 920943, store at -20 degrees Celsius or colder. 2. Record review on 7/22/19 of the Access Folate and Free T4 Calibrators package inserts revealed, "Store at -20 degrees Celsius or colder." 3. Record review on 7/22/19 of the laboratory's 2019 'Old Freezer (Hall), Temp-Chex Temperature Record' chart revealed: a. The acceptable temperature range on the chart did not match the temperature storage requirements for the contents listed in a.i. and a.ii above. b. The acceptable temperature range listed on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the chart is less than or equal to 2 to -20 degrees Celsius. c. The freezer temperature was out of the manufacturer's range for a.i. above for 7 of 143 working days from 1/1 /19 through 7/22/19. d.