Summary:
Summary Statement of Deficiencies D0000 A recertification survey was initiated on 06/15/2023. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. 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 direct observation, manufacturer's instructions, and staff interview; the laboratory failed to monitor and document room temperature for 3 of 3 storage areas. Findings included: 1. Observed on 06/15/2023 at 3:00 p.m. were the following three areas in the laboratory where Becton Dickinson (BD) blood collection tubes were stored: a. Hallway closet; Six (6) packs of one hundred (100) BD Vacutainer K2 Ethylenediaminetetraacetic Acid (EDTA) blood collection tubes, Lot Number 2227128; thirteen (13) packs of one hundred (100) BD Vacutainer Serum Separator Tubes (SST) blood collection tubes, Lot Number 3075122 b. Blood Drawing Room #2 Twenty-four (24) BD Vacutainer K2 EDTA collection tubes c. Blood Drawing Room #3 Fourteen (14) BD Vacutainer K2 EDTA collection tubes Forty-four (44) BD Vacutainer SST collection tubes No temperature monitoring devices were observed in the three rooms. 2. The manufacturer's instructions on the label of each package of the BD blood collection tubes stated a storage requirement of 4 degrees Celsius (39.2 degrees Fahrenheit) to 25 degrees Celsius (77 degrees Fahrenheit). 3. In an interview 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 -- on 06/15/2023 at 3:35pm, the General Supervisor stated that the temperature was not monitored. This confirmed the findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the manufacturer's instructions, direct observation, and interview with the General Supervisor, the laboratory failed to label one of nine in-use reagents with open and revised expiration dates. a. Review of the manufacturer's instructions titled, "Calibrator for automated systems cobas", stated on page 1, "Stability of the components in the reconstituted calibrator: at 2-8C 2 days." b. A sampling of calibration reagents observed stored in the refrigerator included: 1. 1 open bottle of C. f.a.s. (Calibrator for automated systems) Calibrator, Lot number 1075350 The laboratory failed to label the bottle with open and revised expiration dates specified by the manufacturer (for 2 days). c. In an interview on June 15, 2023 at 3:09 PM in the laboratory, the General Supervisor confirmed the findings. *Word Key: C=degrees Celsius D5783