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 observation , a lack of documentation and interview with laboratory staff it was determined that the laboratory failed to define and monitor the conditions for proper storage of supplies consistent with manufacturer ' s instructions in one of one room in which supplies with storage temperature requirements were stored. Survey findings follow: A.On a tour of the facility conducted at approximately 1400 on 6/26 /19, 230 BD EDTA blood collection tubes, lot # 8215703 expiration date 2019-12-31 , and 400 BD SST blood collection tubes lot # 8261880 expiration date 2019-9-30 all with storage temperature requirement of 4 degrees C. to 25 degrees C. were observed in the laboratory room. B. Upon request, the laboratory was unable to provide documentation of room temperatures for the room identified above. C. In an interview on 6/26/19 at approximately 02:00 PM the laboratory staff member identified on the Entrance Conference Attendance Record confirmed that room temperature was not monitored for the room identified above.. 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 --