Eagle Central Laboratory

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor observation, review of 2021, 2022 and 2023 laboratory maintenance records, review of 2021, 2022 and 2023 temperature and humidity logs and technical consultant interview 10/12/23, the laboratory failed to ensure a mechanism was in place to monitor the calibration of the thermometer and hygrometer used to record the humidity and temperature of the main laboratory. Findings: At approximately 5:00 p.m. surveyor observed on a counter top in the laboratory a Fisher Scientific thermometer and hygrometer, serial number (S/N) 91077206, labeled LAB 1, with a calibration due date of "08/14/11". Review of 2021, 2022 and 2023 laboratory maintenance records revealed yearly calibrations of centrifuges and verification of thermometers. The records failed to include a calibration of the Fisher Scientific thermometer and hydrometer, S/N 91077206. Review of 2021, 2022 and 2023 temperature and humidity logs revealed the following dates in which humidity was less than the acceptable low range of 20 percent (%): a. January 2022, 4-7, 10-14, 18-21, 24-28 and 31, humidity was recorded at 18%.

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2018, 2019, and 2020 hematology records and interview with TP (testing personnel) 3/5/20, the laboratory failed to retain documentation of daily background checks performed on the DXH-800 for at least two years. Review of 2018, 2019, and 2020 DXH-800 hematology records revealed there were no background records available for review. During interview at approximately 3:40 p. m., TP #4 and the TC stated that they thought backgrounds were stored in the analyzer. An attempt to print a random background from March 2018 revealed the background reports were not available for March 2018. Additional attempts to print background reports revealed reports from 8/15/18 to 3/5/20 were available in the analyzer, but the reports indicated a pass/fail result only and did not include the actual values obtained. D5781