Summit Express Urgent Care Llc

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 a review of the temperature records and an interview with the Laboratory Director (also the Technical Consultant), the laboratory failed to monitor and document the refrigerator and freezer temperatures on four days in 2019. The findings include: 1. A review of the temperature records revealed no documentation of temperature monitoring of Refrigerator #1 on 04/07/2019 and 09/14/2019. The laboratory indicated an established, normal range of 36 - 46 degrees Fahrenheit (F) as acceptable. The temperature of the freezer (normal range: less than or equal to -20 degrees Celsius) was not documented on 04/08/2019 and 09/10/2019. 2. During an interview on 11/19/2020 at 1:20 PM, the Laboratory Director confirmed there were days where the temperatures were not documented without any

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the AcT Diff calibration records, the procedure manual, and an interview with the Laboratory Director (also the Technical Consultant), the laboratory failed to perform two of three calibrations at least every six months per the laboratory's policy. The findings include: 1. A review of the AcT Diff calibration records revealed a calibration was performed in April of 2016 and November of 2017 by the laboratory; however no other documentation of calibration were provided during the survey. 2. A review of the procedure manual revealed ".... Calibration performed every six months". 3. During an interview on 4/10/2018 at 2:01 PM, the Laboratory Director was asked if the laboratory had any other calibration records, the Laboratory Director reviewed the calibration records with the surveyor and confirmed the laboratory had no other calibration records on file. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the Laboratory Director (also the Technical Consultant), the surveyor determined the Technical Consultant failed to ensure semi-annual evaluations were performed during the first year of employment for two of five testing personnel. The findings include: 1. A review of the personnel records revealed no semi-annual evaluations were performed for Testing Personnel (TP) #1 and TP # 5. TP #1 was hired in September of 2017 and initially trained in July of 2017. TP #5 was hired in July of 2017 and initially trained in August of 2017. 2. In an interview with the Laboratory Director conducted on 4/10/2018 at 10: 30 AM, the Laboratory Director was asked if there were semi-annual evaluation records for TP #1 and #5. The Laboratory Director reviewed the personnel records and confirmed no semi-annual evaluation were performed for TP #1 and #5. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --