Summary:
Summary Statement of Deficiencies D0000 This is the validation survey of the laboratory conducted on 1/15/2019. 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 observations made during a tour of the laboratory, a review of the "Daily Temperature Checks" for January through December 2018, and interviews with staff, it was determined the laboratory criteria for storage of Becton Dickinson (BD) Vacutainers was not consistent with the manufacturer's instructions. Survey findings include: A. During a tour of the laboratory at 11:15 a.m. on 1/15/2019 the surveyor observed K2 EDTA BD Vacutainers (lot #8276782), PST Gel BD Vacutainers (lot #8099812), and Serum Blood Collection Tube BD Vacutainers (lot #8262609) stored at room temperature in the laboratory cabinets. The manufacturers storage instructions on the packages states that the BD Vacutainers are to be stored at 4 to 25 degrees Celsius. B. Through a review of the "Daily Temperature Checks" for January through December 2018 it was revealed the acceptable range for room temperature was listed as "18 to 30 degrees Celsius". C. A review of the "Daily Temperature Checks" for January through December 2018 revealed that the temperature in the laboratory was documented higher than the manufacturer's required storage range (4 to 25 degrees Celsius) on nine of twenty-two days in January, sixteen of twenty days in February, twenty-two of twenty-two days in March, twenty-one of twenty-one days in April, 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 -- twenty-two of twenty-two days in May, twenty-one of twenty-one days in June, twenty-one of twenty-one days in July, twenty-three of twenty-three days in August, nineteen of nineteen days in September, twenty-three of twenty-three days in October, nineteen of twenty days in November, and eighteen of twenty days in December. D. In an interview, at 11:15 on 1/15/2019, laboratory employee #2 (as listed on the CMS- 209 form) confirmed the acceptable temperature range on the log did not match the manufacturer's storage requirements for the BD Vacutainers and that temperatures had been above the acceptable storage requirements. D5783