Summary:
Summary Statement of Deficiencies D0000 Federal Jurisdictional Survey The laboratory is in compliance with 42 CFR part 493 with standard level 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 review of manufacturer's instructions, temperature charts, and interview, the laboratory failed to have defined the correct criteria conditions for proper storage of reagents at room temperature for hematology (DxH 800) as evidenced by: 1. In review of the manufacturer's instructions for reagents it states for Beckman Coulter DxH 800 analyzer: a. Differential pack store at 2-25 degrees C. b. Cleaner store at 2-25 degrees C. 2. In review of the laboratory's temperature charts the laboratory defined a criteria outside of the proper room temperature storage range: 15-30 degrees C. 3. In review of the room conditions temperature graphs for (all day monitoring) May 25th- 27th and June 1st, 8-10, for three days ,the room temperature was above 25 degrees C at certain periods of the day. The temperature graphs show that they are above 25 degrees without a numeric value. The following dates and times were seen above 25 degrees on the chart : a. 6-10-2018 @ 4pm b. 5-27-2018 @12PM c. 5-26-2018 @4 pm The laboratory did not take any remedial actions and was unaware of the storage requirements by the manufacturer. 4. In interview with the Laboratory Director on 3- 18-2019 @1115 am she stated that she was not aware that reagents had a tighter Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- storage temperature. She also stated that everything must have changed when they went to the DxH 800 a few years ago. 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 record review, manufacturers instructions and interview with staff the laboratory failed to document open vial stability of Coulter 6 C quality control material. as evidenced by: 1. Coulter 6C manufacturers instructions state: " 16 Open Vial days, assumes that the instruction for use section of the package insert is performed a maximum of 18 times within 16 days. 2. Direct observation of current lot of Coulter 6c materiel in the refrigerator( L1 123192490, L2 133182490, L3 143192490) was observed @ 1115 on 0303/18/19 without new expiration date on the vial or documented. 3. In interview with the Director @ 1115 on 03/18/19, she stated : The QC was good for 7 days and they typically run qc 2 times per day during lot rollover and every 4 hours during sessions, , and no means to ensure 18 events in 16 days were not surpassed." D5783