Dba Alabama Oncology

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 Hematology calibration records, a review of the Cell-Dyn Emerald Operator's Manual, and an interview with Testing Personnel #1, the laboratory failed to follow the manufacturer's instructions to perform quality controls after calibration, and before running patient/proficiency testing samples. This was noted on two of nine 2018-2021 calibrations reviewed. The findings include: 1. A review of Hematology records revealed the Cell-Dyn Emerald was calibrated on 07/20 /2020 at 12:10 PM. However, quality control was not performed following the calibration and ten patient samples were tested on 07/20/2020 after 12:34 PM. The instrument was also calibrated on 11/23/2020 at 03:20 PM without quality control being performed following the calibration and five proficiency testing samples were tested on 11/23/2020 after 4:00 PM. 2. A review of the Cell-Dyn Emerald Operator's Manual revealed in Section 11 Quality Control (Page 11-3) "...Quality control specimens must be run and results confirmed to be within acceptable limits before reporting patient results. Abbott recommends you, run controls:...After calibration 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 -- (confirmatory step)..." 3. During an interview on 05/04/2021 at 12:15 PM, Testing Personnel #1 confirmed the above findings for 07/20/2020 and 11/23/2020. -- 2 of 2 --

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 environmental records, the Abbott Cell Dyn Emerald Hematology analyzer Operator's Guide and an interview with Testing Personnel (TP #1), the surveyor determined the laboratory failed to monitor and document correct humidity readings in the room where Hematology testing was performed. The findings include: 1. A review of the Installation Environment section in the operator's manual for the Abbott Cell Dyn Emerald Hematology analyzer revealed the following on page 2-4, "...The following are environmental requirements: ...Maximum relative humidity 80% (percent) for temperatures up to 90 degrees F...". 2. A review of the January 2017 thru July 2018 temperature/humidity logs revealed testing personnel recorded 77% with no variation every day of patient testing during this one and a half year period. The Technical Consultant had documented her reviews on each of the logs. 3. During an interview on 7/26/2018 at 1:20 PM, TP #1 was asked if staff were recording the humidity correctly since the readings had not varied in the last year and a half. TP #1 showed the surveyor the device, and pointed to the reading of 77 degrees F (Fahrenheit) and 92%, indicating they were recording 77% as the daily humidity. The surveyor observed the device was a Fisher Scientific digital Thermometer / Hygrometer with the ability to display the maximum and minimum temperature and 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 -- humidity. The device was currently set to display the maximum temperature and humidity. The surveyor then asked if staff were hitting the clear/reset button on the device each day so the current information would be displayed. TP #1 stated they had never been taught this step, and were just reading whatever was on the left side (77) and recording this number as the humidity. Thus the above noted findings were substantiated. [NOTE: The surveyor found no problems with the room temperature monitoring, since testing personnel had recorded the temperatures correctly from a display on the digital wall clock, not the Fisher Scientific device.] SURVEYOR:Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --