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 review of the laboratory's temperature records, and interview with the laboratory personnel, it was determined that the laboratory failed to follow their defined criteria for temperature monitoring and recording. The findings included; a. Review of a temperature chart, :AFMC Andrology Lab Daily QC" for the month of Jan. 2020. b. On the Daily QC chart listed "Room T" 72-82 F; Humidity 20-60 %; "Heat block" (36.5 -37.5 oC; "Refrigerator" 2-4 oC; "freezer" -15 - -18oC; "incubator" 35-37.5 oC. c. There were a total of 12 days the laboratory performed semen analyses onsite as listed in item d, "Summary temperature chart". d. Summary of the temperature charts in 2020 with corresponding records related to its temperature parameters on the day semen analyses were performed as follow: Rm T = room temperature; F = Fahrenheit; oC = Celsius Criteria for: Room T (72 -82 F); Heat Block (36.5-37.5 oC); Freezer (-15 to -18 oC); incubator (35-37.5 oC) Date Rm T Heat block freezer incubator 01/03 19.8 38.0 -15,2 01/08 19.7 38.0 -14.8 3 (?) 01/10 20.0 38.0 -16.7 01/13 17.8 38.0 -11.2 01/16 16.4 38.0 -15.1 01/17 15.4 38.0 -10.1 01 /21 16.4 38.0 -17.8 01/23 16.1 38.0 -10.0 01/24 16.4 38.0 -12.9 01/28 17.8 38.0 -18.3 01/29 15.9 38.0 -10.2 01/30 16.8 38.0 -9.8 e. The laboratory established the acceptable "Room T" was between 72-82 F (Fahrenheit), all of the total of 12 days temperature recorded were between 15 and 20 F, which were all outside of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- established 72-82 F, f. The laboratory established the acceptable "Heat block" was between 36.5-37.5 oC, all of the total of 12 days temperature recorded were 38.0, which were all outside of the established between 36.5-37.5 oC, g., The laboratory established the acceptable "freezer" was between -15 to -18 oC, 7 out of of the total of 12 days temperature recorded were between -9.8 and -14.8 oC which were outside of the established acceptable temperature between -15 to -18 oC. h. The laboratory established the acceptable "Incubator" temperature was between 35--37.5 oC. The testing personnel addressed that the incubator is used for keeping the semen specimen under proper temperature environment while waiting for liquefactions. i. There were no temperature recorded incubator column for the total 12 days except a "3" written on 01/08. j. The temperature records in the January 2020 month showed many temperature records outside of the acceptable temperature ranges. D5781