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 observation and interview with the Technical Consultant (TC), the laboratory failed to calibrate and/or replace the expired thermometer in the Frigidaire refrigerator for 7 (12/07/2021 to 7/26/2022) of 7 months of operation. Findings include: 1. During a tour of the laboratory on 7/26/2022 at 9:00 am, the surveyor observed a Control Company thermometer in the Frigidaire refrigerator with an expiration date of 9/09/2018. 2. A record review of the "General Maintenance" policy in a section labeled "Thermometer check" step 3, "Verify accuracy of temperature readings annually by comparison to a NIST calibrated thermometer (or NIST traceable thermometer) or utilizing a certification services." 3. During the exit interview on 7/26/2022 at 1:45 pm, the TC confirmed the thermometer had expired and was not calibrated and/or replaced. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to ensure control materials were not used when they exceeded their expiration date for 3 (7/14/2022 low control, 7/15/2022 low and normal control, and 7 /18/2022 low, normal, and high control) of approximately 127 testing dates reviewed. Findings include: 1. A review of the laboratory's "All Sample Summary Report" from January 2022 to July 26, 2022 revealed for 3 (7/14/2022 low control, 7/15/2022 low and normal control, and 7/18/2022 low, normal, and high control) of approximately 127 testing dates the controls flagged "*" after the parameters. 2. A review of the laboratory's quality control testing records revealed an "EC" flag on the individual control reports indicating the quality control material was expired. 3. A record review of the "Quality Control and Assessment" policy lacks the directive of what to do when the quality control material has expired. 4. A review of the laboratory's quality control inserts revealed for lot number 22202-3K the quality control materials had an expiration date as follows: a. 22202-31 low control expired on 7/13/2022 b. 22202-32 normal control expired on 7/14/2022 c. 22202-33 high control expired on 7/15/2022 5. An interview on 7/26/2022 at 1:30 pm, the TC confirmed the laboratory did not ensure quality control materials were not used when the expiration date had been exceeded. D5781